Syphilis screening in pw 5th jan

i
Screening for Syphilis
During Pregnancy
Technical &
Operational Guidelines
Maternal Health Division
Ministry of Health & Family Welfare
Government of India
December 2014
SCREENING FOR
DURING PREGNANCY

Designed and printed with support from UNFPA
Designed by: Rouge Communications, New Delhi
E-mail: rougecommunications@gmail.com

Government of India
December 2014
SCREENING FOR
DURING PREGNANCY

As part of national and international commitments, India is steadfast in its
resolve to reduce the Maternal Mortality Ratio (MMR) by 75 percent of its 1990
levels i.e. about 560 deaths per 100,000 live births to 140 deaths per 100,000
live births by the year 2015. Going by the past trends in reduction of MMR,
India seems to be on the right track, and we hope to reach the MDG-5 target
for our country by the end of next year.
However, we need to capitalize on the ground gained and consolidate what we
have achieved. Post 2015, the world will focus on achieving the Sustainable
Development Goals (SDGs). International discussions on SDGs clearly bring
out that not only do we need to continue working on reducing MMR to much
lower levels; we also need to focus on maternal morbidities that have an
adverse effect on not just the health of the mother but also on the foetus.
Infectious diseases such as Syphilis have the potential of being transmitted
from mother to child and also increase the risk of perinatal and neonatal
mortality. Congenital Syphilis can be eliminated by the sincere implementation
of these guidelines.
These guidelines are being brought out at a very opportune moment, addressing
a need that is being felt not just at the national but at the global level. I am
confident that these guidelines will become an integral part of the antenatal
care package and that states will take up the implementation of this initiative
with full vigour and commitment.
Lov Verma
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Government of India
Department of Health & Family Welfare
Lov Verma
Secretary
Preface

India is witnessing significant changes in the health sector. Improvements
in the health systems with respect to infrastructure, personnel, and financial
allocations are already showing impact in terms of reductions in maternal and
child mortality rates. The proportion of maternal deaths attributable to direct
obstetric causes is declining, because interventions to tackle causes such as
haemorrhage, pregnancy induced hypertension etc. are being implemented.
As we move forward toward achieving our national and international
commitments, it becomes imperative to address the challenges of shifting
burden of disease, where now we see a greater proportion of maternal deaths
attributable to indirect causes such as infections. Whilst we need to continue
our efforts for tackling obstetric complications, we also need to initiate work on
managing indirect causes that put a substantial proportion of our mothers and
children at risk.
Syphilis is one such infection for which mother to child transmission is one of
the known routes for spread of the disease. Early and timely identification of
pregnant women who have this infection, through use of simple diagnostic tests
is important to initiate the needed management in positive cases. This will not
only prevent congenital transmission of the infection, but will also improve the
health of the mother.
I would like to congratulate the Maternal Health Division in framing these
guidelines with the help of NACO, institutional experts and development
partners.
These guidelines are the first step towards managing this infection which cause
significant maternal and neonatal mortality and morbidity. I am hopeful that all
health personnel will take cognizance of these new guidelines and incorporate
screening for this infection as an integral component of the antenatal care
package.
C.K. Mishra
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Government of India
Nirman Bhavan, New Delhi - 110011
C.K Mishra, IAS
Additional Secretary &
Mission Director, NHM
Telefax : 23061066, 23063809
E-mail : asmd-mohfw@nic.in
Foreword

Persons affected with sexually transmitted infection like syphilis form a
substantive proportion of our population, including pregnant women. These
infections can easily be transmitted from mother to child. Their occurrence
during pregnancy poses a risk to the health of not just the mother, but also that
of the newborn child.
Pregnancies in many of the infected mothers end in spontaneous abortion,
low birth weight babies or babies with severe infection. Unlike many neonatal
infections, congenital syphilis is preventable. The WHO has set a goal of
eliminating congenital syphilis and urges countries to undertake appropriate
public health measures such as antenatal screening and treatment of infected
pregnant women to prevent this transmission.
Diagnostic tests for syphilis screening are relatively simple and cost effective.
Starting with point-of-care testing kits, these guidelines present detailed
algorithms on the steps to be taken for confirmation and management of these
infections once the pregnant woman is found to be positive on the basis of the
screening tests. It is hoped that universal application of these simple screening
tests will go a long way in reducing the burden of syphilis and soon eliminate it.
The guidelines have been prepared by Maternal Health Division with the active
support of NACO, institutional experts and development partners. These
guidelines aim to facilitate the State and District Programme OWfficers for
effective implementation.
Dr. Rakesh Kumar
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Government of India
Dr. RAKESH KUMAR, I.A.S
Joint Secretary
Telefax : 23061723
E-mail : rk1992uk@gmail.com
E-mail : rkumar92@hotmail.com
Foreword

In 2005, Ministry of Health and Family Welfare, Government of India, released
the Guidelines for Skilled Attendance at Birth by ANMs and LHVs. This marked
a paradigm shift in programming for improving maternal health as not only did
we move away from the previous strategy of training traditional birth attendants,
but, more importantly, ANMs and staff nurses were given the legal rights to
perform certain life saving interventions and administer life saving drugs in
clearly defined conditions and obstetric complications, which would otherwise
have had an adverse impact on the mother’s health, including causing death in
extreme circumstances. These landmark changes, coupled with skill building
of human resource on the same and improved infrastructure, has resulted in
increasing numbers of safe deliveries at public health facilities and reductions
in maternal mortality due to common obstetric complications.
Even though that work is far from over, and we need to continue to maintain
focus on the direct obstetric causes of maternal mortality, data is beginning
to show an increasing proportions of non-obstetric causes and pre-existing
conditions as causes of maternal deaths. syphilis is one such infection which
has an adverse impact on the health of the mother and the foetus. syphilis
infection in the mother carries the risk of congenital transmission which can
affect the health of the newborn, in the immediate and long-term.
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Government of India
Dr. H. BHUSHAN
Deputy Commissioner (MH)
Telefax : 23062930
E-mail : drhbhushan@gmail.com
Programme Officer's Message

I would like to express that these guidelines would not have been possible
without the constant encouragement from Mr. C.K Mishra, AS & MD &
Ms Anuradha Gupta, Ex AS & MD. Dr. Rakesh Kumar, Joint Secretary
(RMNCH+A) headed the expert group meeting and gave valuable inputs in
framing this guideline.
I would like to acknowledge the contribution of all members of the Expert
Group in developing the content of these technical and operational guidelines.
I would also like to acknowledge my colleagues in MH Division especially
Dr. Dinesh Baswal, DC (MH) and development partners for their valuable
efforts and inputs in developing this document.
I am extremely hopeful, that these guidelines, along with the others, will usher
in a new era of maternal health care in the country, where in every pregnancy
the mother and child is protected not just from potential mortality, but also from
debilitating illnesses.
Dr Himanshu Bhushan

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During Pregnancy
List of Contributors
1 Shri C. K. Mishra AS & MD (NHM), MoHFW
2 Dr. Rakesh Kumar JS (RMNCH+A), MoHFW
3 Dr. Himanshu Bhushan DC (I/c MH), MoHFW
4 Dr. Dinesh Baswal DC (MH), MoHFW
5 Dr. Manisha Malhotra DC (MH), MoHFW
6 Dr. Pratima Mittal Prof. & Head, Dept of Obstetrics &
Gynaecology, VMMC & Safdarjung Hospital,
New Delhi
7 Dr. M.K. Mittal Sr. Specialist / Consultant Radiologist,
Safdarjung Hospital, New Delhi
8 Dr. Bhartendu Kumar Assoc. Prof. of Surgery, SKMCH, Muzaffarpur
9 Dr. Ratna Kumar Chennai, Ex HoD, Institute of Obstetrics &
Gynaecology, Chennai, Tamil Nadu
10 Dr. K. Kolanda Swamy Director Public Health, Govt. of TN, Chennai
11 Dr. Ragini Mehrotra HOD, Obstetrics & Gyneacology, AIIMS
Bhopal
12 Dr. Sudhir Gupta Prof & Head, Dept of Gastroenterology, GMC
& Super-speciality Hospital, Nagpur
13 Dr. Somesh Gupta Assoc. Prof., Department of Dermatology &
Venereology, AIIMS, New Delhi
14 Dr. Suneeta Mittal Sr. Consutant - Obstetrics & gynaecology,
Fortis Hospital, Gurgaon
15 Dr. Archana Mishra DD (MH), GoMP
16 Dr. Aman Kumar Singh Technical Expert STI, NACO
17 Dr. Suchitra Pandit President, FOGSI
18 Dr. Achala Batra Dept. of Obstetrics & Gynaecology, Safdarjung
Hospital, New Delhi
19 Dr. P.R. Deo UNFPA State Program Coordinator, Bhopal,
Madhya Pradesh

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During Pregnancy
20 Dr. Anchita Patil National Programme Officer, UNFPA,
New Delhi
21 Dr. Pushkar Kumar Lead Consultant, MH, MoHFW
22 Dr. Rajeev Agarwal Senior Mgt. Consultant, MH, MoHFW
23 Dr. Ravinder Kaur Senior Consultant, MH, MoHFW
24 Dr. Gulfam Ahmed Hashmi Regional Coordinator, NRU, MoHFW
25 Dr. Ashish Chakraborty Regional Coordinator, NRU, MoHFW
26 Mr. Prasanth K. S. Senior Consultant, PHA Division, NHSRC
27 Dr. Neelima Singh Faculty, Indian Institute of Health and Family
Welfare, Hyderabad
28 Dr. Nomita Chandiok ICMR
29 Dr. Raja Mahendra Radiologist, Daga Hospital, Nagpur
30 Dr. Charu Lata Mahorkar Obstetrician & Gynaecologist, Nagpur
31 Dr. Arunabh Ray BTAST, Patna
32 Mr Shridhar Pandit Programme Officer, NRHM, Govt. of
Maharashtra
33 Dr Gorakh Gopalkrishna
Mandrupkar
Joint Secretary, FOGSI
34 Sharmila G. Neogi Maternal Health Specialist, USAID India
35 Dr. M. Naina Rani National Consultant PPTCT WHO
36 Dr. Tarun Singh Sodha Consultant, MH, MoHFW
37 Dr. Sudhir Maknikar National RMNCH+A Expert, JSI
MGIMS Team
38 Dr. B.S. Garg Secretary, KHS, MGIMS, Sevagram
39 Dr. Poonam Varma Shiv
Kumar
Prof. and Head, Dept. of Obstetrics &
Gynaecology, MGIMS, Sevagram
40 Dr. Manjiri Ramteke Podder Assistant Prof., Dept of Obstetrics &
Gynaecology, MGIMS, Sevagram

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During Pregnancy
List of Acronyms
ANC Antenatal Care
ART Antiretroviral Therapy
ASHA Accredited Social Health Activist
CBO Community-based Organization
CMIS Computerized Management Information System
CS Congenital Syphilis
DSRC Designated STI/RTI Clinics
ePTCT Elimination of Parent-to-Child Transmission
ECS Elimination of Congenital Syphilis
EIA Enzyme Immunoassay
ELISA Enzyme-linked Immunosorbent Assay
FSW Female Sex Worker
FTA-ABS Fluorescent Treponemal Antibody Absorption Test
HIV Human Immunodeficiency Virus
HMIS Health Management Information System
HRG High Risk Groups (for HIV)
HSS HIV Sentinel Surveillance
ICS/ICT Immuno Chromatographic Strip (test)
ICTC Integrated Counselling and Testing Centres
IEC Information Education and Communication
Ig Immunoglobulin
F-ICTC Facility Integrated Counselling and Testing Centres
INGO International Non-governmental Organization
JSSK Janani Shishu Suraksha Karyakram

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During Pregnancy
RMNCH+A Reproductive, Maternal, New Born, Child Health and
Adolescent Health
MCTS Mother and Child Tracking System
MDGs Millennium Development Goals
MSM Men who have Sex with Men
MSW Male Sex Worker
MTCT Mother-to-Child Transmission
NGO Non-governmental Organization
NACO National AIDS Control Organisation
NACP National AIDS Control Programme
NHM National Health Mission
PCR Polymerase Chain Reaction
PPTCT Prevention of Parent-to-Child Transmission
RPR Test Rapid Plasma Reagin (Test)
RTI Reproductive Tract Infection
SEAR South-East Asia Region
SEARO South East Asia Regional Office (WHO)
SRH Sexual and Reproductive Health
STI Sexually Transmitted Infection
TPHA Treponema Pallidum Haemagglutination Assay
TP IgM Treponema Pallidum IgM Enzyme-linked Immunosorbent Assay
TPPA Treponema Pallidum Particle Agglutination Assay
VDRL Venereal Disease Research Laboratory (Test)
WHO World Health Organization

Introduction1
CHAPTER
2
CHAPTER
3
CHAPTER
4
CHAPTER
Technical Guidelines on Testing &
Management of Syphilis
Protocol for Investigation & Management
of Syphilis
Operational Plan for Investigation and
02
05
08
17
29
37References
Annexures
Annexure – 1: Anaphylaxis Management
Annexure – 2: Technical Specifications of Rapid Plasma
Reagin (RPR) Test Kits for Syphilis Testing
Annexure – 3: Technical Specifications of Treponemal-
specific Rapid (point-of-care) Diagnostic
Test for Syphilis
Annexure – 4: Referral Slip
Annexure – 5: Migration Form for Pregnant Women
with Syphilis
Annexure – 6: Monthly Syphilis Reporting Format for
State & District Programme Managers
Annexure – 7: Monthly Syphilis Reporting Format for
Health Facility

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During Pregnancy
Introduction
Syphilis is a sexually transmitted infection caused by
the spirochaete bacterium Treponema Pallidum,
subspecies Pallidum. The primary route of transmission
is through sexual contact; it may also be transmitted from
mother to foetus during pregnancy or at birth resulting in
congenital syphilis.
The signs and symptoms of syphilis vary depending on
which of the four stages it presents (primary, secondary,
latent and tertiary). The primary stage classically presents
with a single chancre (a firm, painless, non-itchy skin
ulceration); secondary syphilis with a diffuse rash which
frequently involves the palms of the hands and soles of the
feet; latent syphilis with little to no symptoms and tertiary
syphilis with gummas, neurological or cardiac symptoms.
1.1 Disease Burden
Data on the incidence and prevalence of STI in the South-
East Asia Region (SEAR) are limited. WHO estimates
approximately 600,000 pregnant women are infected with
syphilis and 230,000 associated adverse outcomes occur
every year in the SEAR.
1
CHAPTER

3
During Pregnancy
Syphilis in pregnancy is an under-recognized problem that carries a
significant public health and economic burden. It is estimated that there are
12 million people infected worldwide, with more than 90% of these cases
being from the developing countries. Each year nearly 1.5 million pregnant
women around the world are infected with active syphilis. Due to widespread
availability of Penicillin in the 1940s there was dramatic decrease in the rates
of infection, which have again increased since the turn of the millennium
in many countries, often in combination with HIV infection. This has been
attributed partly to unsafe sexual practices and decreasing use of condoms.
In the 2010–11 round of HIV sentinel surveillance, the average serological
prevalence of syphilis (qualitative test result) among ANC attendees of 696
selected ANC sites was 0.38%. Arunachal Pradesh (2.86%) has shown the
highest prevalence of syphilis followed by West Bengal (1.91%), Rajasthan
(1.17%), Punjab (0.95%), Meghalaya (0.90%), Madhya Pradesh (0.66%),
Andaman Nicobar Island, Uttar Pradesh and Tripura (0.63%) and
Odisha (0.62%).
1.2 Impact on the Millennium Development Goals
(MDGs)
With 2015 approaching, international and national focus is on achieving the
Millennium Development Goals (MDGs). Screening for and management of
syphilis during pregnancy is the next step forward by the Government of India
(GoI) in achieving MDGs 4, 5, 6.
Screening and
management of
syphilis will result in
reduced incidence
of low birth weight
(LBW), perinatal
deaths and congenital
syphilis
Reduction in the
incidence of stillbirth
and spontaneous
abortions will result in
improved pregnancy
outcomes and
reduced maternal
morbidity.
Reduction in co-
morbidities like HIV
will occur due to
improved behaviours
following counselling

4
During Pregnancy
1.3 Consequences of Syphilis
The global estimate of adverse outcomes of syphilis in pregnancy in 2008
was about 520,000. Of this large number, early foetal deaths/stillbirths are
215,000; neonatal deaths 90,000; pre-term/LBW 65,000 and congenital
diseases 150,000. An estimated 96% of maternal syphilis infection and 98%
of adverse outcomes occurred in low and middle-income countries. From
2008 to 2012, maternal syphilis infections and adverse pregnancy outcomes
declined by 33%; however the pace of decline needs to be accelerated.
1.4 Need for National Guidelines
As syphilis is known to cause adverse outcomes in pregnant women and
newborns, these guidelines offer clear technical recommendations and
operational framework for screening pregnant women and managing them
when detected positive.

5
During Pregnancy
Technical Guidelines on
Testing and Management of
Syphilis During Pregnancy
2.1 Goal
To reduce maternal and newborn morbidity and mortality
and move towards detection and treatment of maternal
syphilis and elimination of congenital syphilis.
2.2 Objectives
ƲƲ To ensure early screening of all pregnant women for
syphilis, preferably in the first trimester;
ƲƲ To detect and manage syphilis infection in pregnant
women and their partners;
ƲƲ To ensure institutional delivery at (FRUs/higher level
institutions) of all syphilis-positive pregnant women;
ƲƲ To prevent the transmission of syphilis from mother
to child.
2
CHAPTER

6
During Pregnancy
2.3 Target Population
ƲƲ All pregnant women and their newborns
ƲƲ Partners of syphilis-positive pregnant women
2.4 Prerequisites for Testing and Management
of Syphilis
ƲƲ Availability of Point-of-Care (POC) testing at Sub-centres (SC) and
outreach sessions such as Village Health and Nutrition Days (VHNDs)
ƲƲ Availability of POC test at any other facility where rapid plasma reagin
(RPR) testing is not available, including at centres where deliveries are
conducted
ƲƲ Availability of RPR testing facility at all the health facilities above sub-
centre
ƲƲ All commodities and human resource for management of syphilis,
relevant to the level of facility
»» Availability of drugs, injectables and consumables required for the
management of maternal and congenital syphilis
»» An emergency kit containing essential drugs, injections and supplies
for managing anaphylactic shock
»» Trained human resource to provide the management to pregnant
women after they test positive for syphilis
»» Appropriate referral linkages to First Referral Units (FRU)/ Emergency
Obstetric Care (EmOC) centers for conducting the delivery of syphilis-
positive pregnant women
»» Availability of Ob-Gyn and pediatrician is mandatory at such FRUs
2.5 Selection of Facilities
ƲƲ States are free to choose the number of districts where the programme
will be implemented
ƲƲ Once a district is chosen, implementation of the programme should
be universal in all health care institutions in that district, right from the
medical college to the sub-centre
ƲƲ All health care facilities in the selected district should have all the relevant
prerequisites in place
ƲƲ The service providers and programme officer must be well oriented and
trained regarding the programme

7
During Pregnancy
2.6 Steps for Implementation
ƲƲ A Government order/policy decision on implementation of the programme
should be issued by the State
ƲƲ Testing and treatment for syphilis to be declared as an integral part of the
essential ANC package
ƲƲ Orientation and training of all programme officers and service providers
involved in the programme
ƲƲ Availability of test kits, consumables, drugs and other logistics, as
relevant at health care facilities in the district identified for rolling out the
programme
ƲƲ Adequate information education and communication (IEC) /interpersonal
communication (IPC) for generating awareness
ƲƲ Availability of different formats, records, registers and other requisite
Monitoring and Evaluation (M&E) tools for documentation, data collection,
collation and for review and evaluation of the programme
ƲƲ Provision of adequate budget and timely release to the implementing
institutions

8
During Pregnancy
Protocol for Investigation and
ƲƲ All pregnant women should be tested for syphilis in
the first ANC visit itself, which should be as early as
possible, by a POC test at the sub-centre level or at
any other facility where the woman visits for ANC,
where laboratory facilities for RPR are not available,
irrespective of her previous syphilitic status.
ƲƲ Those women who go for ANC check-up at health care
facilities where testing for RPR is available should be
tested by RPR method (qualitative and quantitative).
ƲƲ Ideally, all women who test positive for syphilis
through POC should undergo testing by RPR also
for confirmation of diagnosis and assessment of the
antibody titres. The latter is important not just for
ensuring appropriate treatment for the woman but also
for deciding on the line of treatment for the newborn.
ƲƲ Those found positive either by POC or RPR should
be treated for maternal syphilis as per the defined
treatment protocol explained in this guideline.
ƲƲ Women who are at high risk for syphilis (see box on
the adjacent page), those who live in areas of high
prevalence of syphilis, those who have had adverse
outcomes of pregnancy previously or those who were
untested earlier, should be screened again in the third
trimester or at the time of delivery.
ƲƲ Testing of spouse/partner of syphilis-positive women
should be mandatory followed by treatment as per
protocol for those found positive.
3
CHAPTER

9
During Pregnancy
Pregnant women considered to be at high risk for acquiring
STIs, including Syphilis:
◘◘ Women with current or past history of STI
◘◘ Women with more than one sexual partner
◘◘ Sex workers
◘◘ Injecting drug users
Ensure readiness of emergency tray for management of
anaphylactic reactions:
◘◘ The tray should be kept in the day-care room.
◘◘ Every morning the tray should be checked for replenishment of used
drugs and for expiry dates of drugs on the tray.
◘◘ List of drugs and consumables that should always be available on the
tray: Inj Adrenaline, Inj Chlorpheniramine Maleate, Inj Dexamethasone,
Inj Hydrocortisone succinate, Inj Deriphylline, Inj Furosemide,
Inj Dopamine, Inj Sodium bicarbonate, Oxygen, Ringer Lactate,
disposable needles, gloves, cotton swabs.
3.1 Treatment Regimen for Syphilis-positive Pregnant
Women and their Partners
3.1.1 Treatment of maternal syphilis
Although severe allergy to penicillin is rare, the provider should rule
out history of allergy before administering penicillin. The emergency
drugs for managing anaphylaxis should be kept ready prior to
administering penicillin (see Anaphylaxis Management at Annexure 1).
i. In the early stage (primary and secondary syphilis of <2 years’
duration; RPR titre< 1:8 approximately), a single intramuscular
injection of 2.4 million IU benzathine benzyl penicillin is sufficient.
ii. In the late stage (tertiary > 2 years or unknown duration, RPR
titre>1:8 approximately), a total of three intramuscular injections of
2.4 million IU benzathine benzyl penicillin once a week for 3 weeks
need to be given.
ƲƲ For all syphilis-positive women detected during ANC by either POC or
RPR, their newborns should be tested by RPR.
ƲƲ All newborns showing four-fold rise in titre compared to that of mother’s
titre need to be hospitalized to initiate penicillin treatment for 10 days.

10
During Pregnancy
Important facts about penicillin use:
Facts about benzathine penicillin injection:
◘◘ Benzathine penicillin injection is the only effective treatment for
preventing congenital syphilis, perinatal deaths, stillbirths and preterm
deliveries in pregnant women with syphilis.
◘◘ A study undertaken by Tais F Galvio, Lori M. Newman et al. (Feb
2013 Journal PLOS ONE) states that no case of serious adverse
reactions to benzathine penicillin injection was reported in pregnant
women and the incidence was very low in the general population.
◘◘ Incidence of adverse reactions in pregnant women treated with
benzathine penicillin injection for preventing congenital syphilis in
studies conducted between 1954 and 2012 have shown only one
case of skin rash.
◘◘ Benefits of benzathine penicillin injection outweigh the risks of
adverse reactions.
Therefore, fears regarding use of benzathine penicillin injection among
doctors should be dispelled.
Alternative Regimen for Penicillin-allergic Pregnant women
Key points:
ýý For the treatment of syphilis during pregnancy, NO PROVEN
ALTERNATIVES TO PENICILLIN exist.
ýý All infants of pregnant women treated with a non-penicillin regimen should
be treated at birth as if mother was not sufficiently treated.
ýý Alternative to penicillin should be considered ONLY for those syphilis-
positive pregnant women who have a history of severe penicillin allergy
(e.g. anaphylaxis).
ýý Erythromycin estolate is contraindicated because of drug-related
hepatotoxicity. Only erythromycin base or erythromycin ethyl succinate
should be used.
The partner or spouse should be treated with the same regimen.
Regimen 1
◘◘ Early-stage syphilis:
Erythromycin, 500 mg orally,
4 times daily for 15 days
◘◘ Late-stage syphilis:
Erythromycin, 500 mg orally,
4 times daily for 30 days
Regimen 2
Primary syphilis (syphilitic
chancre): Azithromycin, 2 g
orally as a single dose
OR

11
During Pregnancy
3.1.2 Follow-up
Follow-up should be done during postnatal care (PNC) visits and in addition,
at 6 months and 24 months after the treatment is administered.
Flowchart 1
Syphilis screening of pregnant women using POC test and treatment of
maternal syphilis at health care settings without laboratory support
Criteria for repeat test:
◘◘ Pregnant women considered to be at high risk for acquiring STI (those with current or past history of
STI, women with more than one sexual partner, sex workers and injecting drug users);
◘◘ Pregnant women with history of repeated abortions, stillbirths, past history of delivery of premature
babies, preterm babies and neonatal deaths;
◘◘ Women living in areas of high prevalence of syphilis;
◘◘ Testing at the time of delivery will also be required to detect re-infection, particularly in those syphilis-
positive women whose partners were not treated;
First visit: ANC
registration - by ANM at
SC, VHND etc.
Screen pregnant woman for
Syphlis using Point-of-Care
(POC) test
Pregnant woman
found syphilis reactive
Pregnant woman found
syphilis non-reactive
Retest high risk
pregnant women* in
third trimester or soon
after delivery
Pregnant woman
Refer to nearest
PHC/CHC/DH
Repeat RPR titre after delivery and
assess infant for appropriate treatment
1. Immediately treat pregnant woman
2. Conduct a qualitative and
quantitative RPR/VDRL test.
3. Test and treat the spouse / partner

12
During Pregnancy
Flowchart 2
Algorithm for syphilis screening of pregnant women and treatment of
maternal syphilis at health care settings with laboratory support
Criteria for repeat test:
◘◘ Pregnant women considered to be at high risk for acquiring STI (those with current or past
history of STI, women with more than one sexual partner, sex workers and injecting drug
users)
◘◘ Pregnant women with history of repeated abortions, stillbirths, past history of delivery of
premature babies, preterm babies and neonatal deaths
◘◘ Women living in areas of high prevalence of syphilis
◘◘ Testing at the time of delivery will also be required to detect re-infection, particularly in those
syphilis-positive women whose partners were not treated.
First visit: ANC registration
at PHC or higher facility
syphilis using RPR/VDRL test
(qualitative & quantitative)
Pregnant woman
Retest high-risk* pregnant
woman in third trimester
or soon after delivery
Pregnant woman
in late third trimesterRepeat RPR/VDRL titre after
delivery and assess infant
for appropriate treatment
1. Immediately treat
pregnant woman
2. Conduct a quantitative and
qualitative RPR/VDRL test.
3. Test and treat the spouse / partner

13
During Pregnancy
Flowchart 3
Algorithm for syphilis screening of pregnant women coming directly in
labour and treatment of maternal syphilis
Pregnant woman
coming directly in labour
syphlis using POC test
Pregnant woman
Conduct a qualitative and
quantitative RPR/VDRL after delivery
for both the mother and the newborn
for comparing the antibody titre
levels of the mother and the neonate
1. Immediately treat the
pregnant woman
2. Test and treat the spouse/partner

14
During Pregnancy
3.2 Neonatal Syphilis
3.2.1 Case Definitions
Suspected case of congenital syphilis
A stillborn or live-born baby of syphilis-reactive mother who has been
inadequately treated
Confirmed case of congenital syphilis
A live born child with serum quantitative RPR titre that is four-fold
higher than the mother’s titre
OR
A child within first 2 years of life with clinical evidence of syphilis and
reactive syphilis serology irrespective of mother’s serology
3.2.2 Signs and Symptoms of Congenital Syphilis
Congenital syphilis may be asymptomatic, especially in the first few
weeks of life, in about 50% of cases. Usually symptoms appear in the
first few months, but the clinical manifestations may be delayed until
the second year of life.
The most frequent clinical signs of congenital syphilis at birth are
hepatosplenomegaly (33% –100%), bone changes seen on x-ray
Fig. 1: Radiograph showing
lower end of humerus (with
periostitis) and proximal
ends of radius and ulna (with
metaphysitis)
(75%–100%) (Fig.1), blistering
skin rash especially on palms
and soles (40%) (Fig.2), fever
(16%), low birth weight (10%–
40%), bleeding (10%), swelling
of the joints, abnormal facies,
snuffles, oedema, abdominal
distension, pallor, respiratory
distress and pseudo-paralysis.
An older child may have
stigmata (e.g. interstitial
keratitis, nerve deafness,
anterior bowing of shins, frontal
bossing, mulberry molars,
Hutchinson teeth, saddle nose,
rhagades, or Clutton joints).

15
During Pregnancy
Fig. 2: Blistering skin rash in neonates
3.3.3 Management of Congenital Syphilis
Regimen 1 (Prophylactic Treatment)
All asymptomatic babies who meet ALL the following criteria:
◘◘ Have no serological evidence of syphilis and
◘◘ Are born to mothers who were adequately treated for maternal
syphilis with penicillin during the current pregnancy and
◘◘ The mother has received the treatment at least 4 weeks prior
to delivery
Should be treated with a single dose of prophylactic penicillin:
Benzathine penicillin G 50,000 units/kg given as a single intramuscular
injection.
Regimen 2 (Curative Treatment)
This should be given to
ýý All symptomatic babies (newborns and older)
ýý All asymptomatic babies-
Asymptomatic newborns
◘◘ Born to mothers who were treated with penicillin less than 4
weeks before delivery
◘◘ Born to mothers who were treated with non-penicillin regimens
(erythromycin or azithromycin) during pregnancy
◘◘ Born to mothers whose treatment status is unknown or
undocumented

16
During Pregnancy
Asymptomatic infant/child
◘◘ Whose RPR/VDRL titre is four-fold higher than that of the
mother at or after delivery
◘◘ Born to mothers with clinical evidence of syphilis
◘◘ With a reactive syphilis IgM antibody test
◘◘ Born to mothers who did not complete the recommended
course of penicillin during pregnancy
◘◘ Born to mothers whose RPR/VDRL titres had not
dropped four-fold
Intravenous (IV) treatment regimen
Aqueous crystalline penicillin G 100,000–150,000 million units/kg/day
intravenously. It could be given as 50,000 units/kg/dose IV every 12 hours
during the first 7 days, and thereafter every 8 hours for 3 days to complete a
total of 10 days of treatment.
OR
Intramuscular (IM) treatment regimen
ƲƲ Procaine penicillin 50,000 units/kg body weight intramuscularly as a
single daily dose for 10 days;
ƲƲ Alternatively, benzathine penicillin G 50,000 units/kg IM in a single dose
Hospitalization of the infant should be considered in order to ensure the full
course of treatment. If more than one day of treatment is missed, the
entire course of treatment should be restarted.
3.3.4 Follow-up
Follow-up should be done during PNC visits as well as at 6 months
and 24 months after the treatment is received.

17
During Pregnancy
Operational Plan for
Investigation and
ƲƲ The programme manager for the state should collect
the data for the estimated number of pregnancies from
each of the districts and direct the district programme
manager to ensure that all pregnant women attending
ANC clinics at government health care facilities receive
screening for syphilis, preferably as part of the first
ANC visit itself.
ƲƲ In the district, about 60% to 70% of the total estimated
pregnancies will avail ANC screening from government
health care facilities (Sub-centre, PHC, CHC, Sub-
divisional Hospital, District Hospital, Medical College,
etc.).
ƲƲ The programme manager at the district will estimate
the caseloads per health care facility based on HMIS
data.
ƲƲ The programme manager will ensure that kits and
consumables for syphilis screening are available based
on the type of health care facility.
ƲƲ Pregnant women will be screened as mentioned in the
algorithm charts.
4
CHAPTER

18
During Pregnancy
4.1 Awareness Generation at the Community Level
All health care workers and professionals should generate awareness in the
community about the importance of screening for syphilis in the antenatal
period by using various IEC methods and strategies including IPC.
4.2 Human Resources Involved
Specialists, medical officers, laboratory technicians and other health care
workers across different levels of health care facilities; no additional human
resources need to be recruited to implementing these guidelines.
4.3 Role and Responsibilities – Defined by Levels of
Health Care Facilities
4.3.1 Village:
ƲƲ Generate awareness among pregnant women regarding the
importance of routine ANC highlighting the importance of screening
for syphilis during early pregnancy.
ƲƲ Mobilize pregnant women to attend VHND/sub-centre as per the
ANC registrations list for getting routine ANC and investigations.
ƲƲ If the pregnant woman is syphilis-positive, ASHA should ensure
her treatment, testing and treatment of spouse/partner, delivery
in an FRU or higher facility through birth planning and prompt
investigation and treatment of the newborn.
ƲƲ Enlist family support as it is required for testing and for ensuring
treatment if the woman is found to be syphilis-positive.
4.3.2 Level I: Sub-centre/VHND
ƲƲ Conduct ANC and testing for syphilis by POC test along with other
mandatory tests during ANC.
ƲƲ If the pregnant woman is reactive to the POC test, she should be
referred to PHC/CHC/Sub-divisional Hospital/District Hospital for
treatment and RPR.
ƲƲ Her spouse/partner should be encouraged to get tested and seek
treatment if found positive.
ƲƲ The ANM will record the test results in the MCP card and RCH
register.
ƲƲ All positive cases should be followed up for treatment.
ƲƲ The test kit should be kept in the refrigerator to maintain the
temperature at 2°C to 8°C.

19
During Pregnancy
ƲƲ If a refrigerator is not available at the sub-centre, then the kits
should be kept at the PHC to maintain cold chain, and be brought
to the VHND or outreach sessions while ensuring that cold chain is
maintained.
4.3.3 Level II: PHC/Corresponding urban centre
All the jobs assigned above plus the following:
ƲƲ RPR test has to be performed by the laboratory technician. In the
absence of a laboratory technician, a staff nurse will do the POC
test and refer syphilis-positive pregnant woman to the Medical
Officer or to a higher centre for treatment and RPR test.
ƲƲ The MO will provide treatment by using the standard treatment
protocol for syphilis.
ƲƲ The MO will also monitor the treatment/investigation required for
syphilis-positive cases and refer to an FRU/higher level centre for
further medical management, if required and conduction of delivery
by the specialist.
4.3.4 Level III
A) DH and All CEmOC Centres
All jobs as defined under Level II plus the following:
ƲƲ Ob-Gyn to conduct the delivery of syphilis-positive pregnant
women
ƲƲ Paediatricians to provide care to the newborn of a syphilis-
positive mother
B) Medical College and Other Super-speciality Centres
Comprehensive management of all cases needing treatment of syphilis
including all referral cases
4.4 Roles and Responsibilities Defined by Cadre of
Health Worker
4.4.1 District RCH Officer/State RCH Officer
ƲƲ Plan the roll-out of syphilis testing among pregnant women
ƲƲ Ensure that all facilities have adequate supply of test kits,
consumables and drugs for at least 3 months
ƲƲ Calculate the health facility-wise case load for sending the supplies
in advance as per consumption pattern

20
During Pregnancy
ƲƲ Coordinate with CMHO/Civil surgeon, State RCH Officer, DPMU
and DAPCU to strengthen service delivery in the field
ƲƲ Monitor the programme to ensure:
»» The storage of all supplies is in accordance with the
manufacturer’s instructions
»» The required drugs are part of the Essential Drugs List (EML)
»» Training of all the health staff
»» All the reporting units provide report on screening and treatment
of pregnant women for syphilis in HMIS
4.4.2 ANM/Staff Nurse
ƲƲ Increase awareness among pregnant women regarding syphilis
screening
ƲƲ Register all pregnant women for ANC and screen for syphilis using
the POC test during first ANC visit
ƲƲ Maintain the ANC register, including record of syphilis test results.
ƲƲ Refer syphilis-positive pregnant women to higher health care
facility for confirmation and treatment
ƲƲ Follow-up syphilis-positive women and their newborns for
treatment
ƲƲ Assist/prepare HMIS and other relevant reports
4.4.3 Laboratory Technician
ƲƲ Conduct syphilis testing test for all pregnant women visiting the
PHC and higher centres for ANC
ƲƲ Maintain the laboratory register
ƲƲ Store test kits as per guidelines
ƲƲ Refer syphilis-positive pregnant women for treatment
ƲƲ Keep records
ƲƲ Testing blood of newborns
4.4.4 Medical Officer
ƲƲ Provide treatment to all the syphilis-positive women,
ƲƲ Test and treat their spouse/partner
ƲƲ Refer the syphilis-positive pregnant women to an FRU for
delivery,and further testing

21
During Pregnancy
ƲƲ Conduct follow-up test after treatment as per guidelines
ƲƲ Follow-up of patient management
ƲƲ Manage the cases of anaphylaxis if any occur
ƲƲ Check for correctness of reporting
4.4.5 In-charge of DSRC (Designated STI/RTI Clinic)
DSRCs are mainly located at district hospitals
ƲƲ Maintain the inventory and stock registers of drugs and test kits
ƲƲ Build capacity of all new STI counsellors
ƲƲ Sensitize the PHC- MOs and ANMs/ASHAs on updates of
the programme
ƲƲ Provide mentoring and supportive supervisory visits to
health facilities
ƲƲ At the STI clinic counselling of pregnant women and laboratory
referral for testing
ƲƲ Counselling all ANC attendees and partners coming to the ANC
clinic and referring to the laboratory for screening/confirmation
of syphilis
4.4.6 Paediatrician/Gynaecologist
ƲƲ Provide delivery services to all pregnant women who test positive
for syphilis
ƲƲ Help in assessing the antibody titres in the newborn’s blood by
drawing blood from the neonate’s cubital vein and sending it to the
laboratory technician for testing by RPR
ƲƲ Provide treatment for the newborn and infant of a syphilis-positive
mother
ƲƲ Provide comprehensive care to a syphilis-positive mother and
her newborn

22
During Pregnancy
4.5 Capacity Building of Human Resource
4.5.1 Training Needs for Different Cadres
Cadre of
Health Care
Functionary Type of Training Content of Training
ASHA General
orientation about
the programme
Orientation on
▪▪ Syphilis disease burden, consequences
for pregnant women and neonates
▪▪ IEC material on awareness
ANM/LHV/SN Knowledge and
skills about POC
screening test for
syphilis
The training for ASHAs, plus
▪▪ POC testing technique
▪▪ Interpreting POC test results
▪▪ Referral required when the test is positive
▪▪ Technique of testing
sensitivity of penicillin
▪▪ Maintenance of records and
different reporting formats
Laboratory
technician
Knowledge and
skills about RPR
and POC test for
syphilis
The training for ANMs plus
▪▪ POC testing techniques
▪▪ RPR testing techniques –
qualitative and quantitative
▪▪ Interpreting POC and RPR test results
▪▪ Referral required when the test is positive
Medical Officer Medical
management of a
syphilis-positive
pregnant woman
▪▪ Interpretation of RPR test results
▪▪ Technique of administration of penicillin
injection through the proper site and route
▪▪ Medical management of
syphilis, including alternative
(to penicillin) therapies
▪▪ Referral to FRU for delivery and
management of newborn
Specialists
(Ob-Gyn,
Paediatrician)
Special obstetric
care of syphilis-
positive pregnant
women
The training for medical officers, plus
▪▪ Special obstetric care: ante-partum,
intra-partum and postpartum
▪▪ Comprehensive medical management
of syphilis-positive pregnant women
▪▪ Technique of drawing venous blood
from newborn from the cubital vein
for RPR test (by paediatrician only)
▪▪ Management of the neonate of
a syphilis-positive mother

23
During Pregnancy
4.5.2 Structure of Training for Syphilis Programme
ƲƲ A one-day training will be organized for syphilis programme in
every district
ƲƲ All participants (programme managers and medical officers [MOs]
in-charge of STI Clinics/DSRCs/District AIDS Prevention & Control
Units/Integrated Counselling and Testing centres/HFWTC/DTC
faculty, Principals, ANMTC/LHVTC; School/s of Nursing; DNOs/
HEOs/ASHA Mentors/ANMs/ SNs/ LHVs/LTs/MOs/Specialists
(Obstetricians; Paediatricians, Dermatologists) will attend
ƲƲ ASHAs will have a separate batch and 1-day training programme
can be incorporated either into their existing module or a separate
orientation programme at block level can be organized
4.5.3 Batch Size
ƲƲ All health care facilities in a district will be mapped
ƲƲ Health personnel of all health care service delivery points need to
be oriented/ trained on a rotational basis
ƲƲ One batch can have 40 to 60 trainees from all cadres
(heterogeneous group)
ƲƲ One batch of trainees will comprise
Programme managers: 3–5
ANM/SN/LHV: 20–25
LT: 5–10
MO/ Ob-Gyn/Paediatrician and dermatologist/ pathologist or
microbiologist: 10–15
ƲƲ Once the health personnel of the designated delivery points in
the district have been trained on a priority basis, other health
personnel involved in ANC care can be oriented
ƲƲ District Training In-charge will prepare a training plan and
calendar accordingly

24
During Pregnancy
4.5.4 Training Sites
Prerequisites:
ƲƲ Seminar/Conference room with capacity of 50–60 participants
ƲƲ Audio-visual and other training aids
ƲƲ At least two in-house Ob-Gyn and one paediatrician
ƲƲ Availability of in-house counsellor, pathologist/ microbiologist,
community medicine faculty is desirable
ƲƲ Any medical college/district hospital having the above
prerequisites can be chosen as a training site/venue
4.5.5 Trainers
ƲƲ MO, Ob-Gyn, paediatrician and dermatologist/pathologist or
microbiologist/specialist in Community Medicine to be included as
trainers as per their availability and area of expertise
ƲƲ One-day training of trainers should be organized for 20–25 trainers
at medical college level
4.5.6 Training Material
ƲƲ GoI guidelines on syphilis
ƲƲ Any other teaching or training material synchronized with GoI
guidelines
ƲƲ Job aids/Posters/Handouts/Flipcharts
ƲƲ Presentations
ƲƲ POC testing strips/cards
4.6 Monitoring and Evaluation Framework
This initiative envisages a focused and robust monitoring and evaluation
system with specific indicators mentioned below to monitor progress of the
initiative across states so as to take appropriate programmatic responses.
NACO and the Maternal Health Division of MoHFW will monitor indicators
identified as critical for monitoring at national level. States and districts will be
responsible for monitoring of these indicators and for ensuring quality of data
collection from the facilities.

25
During Pregnancy
4.6.1 Key performance indicators for Syphilis Screening (KPI)
ƲƲ Number of pregnant women tested for syphilis out of total ANCs
registered
ƲƲ Total number of syphilis-positive pregnant women detected out of
those tested
ƲƲ Total number of pregnant women adequately treated (i.e. received
one dose of benzathine penicillin injection) for syphilis
ƲƲ Total number of confirmed cases of congenital syphilis
ƲƲ Total number of babies born to syphilis-positive mothers who
received treatment
4.7 Budget
ƲƲ Infrastructure: No additional infrastructure required
ƲƲ Human resource: No separate human resource required
ƲƲ Equipment/Instruments: No additional equipment or infrastructure
required
ƲƲ Testing kits, consumables and drugs required for this programme need to
be budgeted for
While estimating the budget required for rolling out this initiative, the following
need to be considered
4.7.1 Estimated Case Loads
ƲƲ All pregnant women availing ANC at public health care facilities will
be screened for syphilis by strip/card test, or by RPR depending
on where they access ANC services
ƲƲ The pregnant women who test positive for syphilis by the POC
test will need to be tested by RPR also (both qualitative and
quantitative)
ƲƲ The pregnant women who test positive for syphilis by POC test will
need benzathine penicillin injection treatment
ƲƲ All spouses / partners of syphilis-positive women should ideally be
tested for syphilis too, and if found positive, then they too will need
to be treated

26
During Pregnancy
ƲƲ Newborns with congenital syphilis or where mothers were
inadequately treated will need to be treated with benzathine penicillin
Estimating these proportions from existing data or from reported data
following initial roll-out will assist in budgeting for this initiative.
4.7.2 Records/Registers and Formats
The following records and registers need to be printed and made
available to the relevant service provider(s)
ƲƲ Monthly syphilis reporting formats for state and district programme
managers (Annexure 6)
ƲƲ Monthly syphilis reporting formats for health care facility (Annexure 7)
ƲƲ Referral slip (Annexure 4)
ƲƲ Migration form for Pregnant Women with syphilis (Annexure 5)
4.7.3 Drugs Consumables and Other Logistics
ƲƲ Estimate the requirement of test kits, drugs, consumables like
lancets, gloves, swabs, etc. and ensure supplies of the same
4.7.4 Training
ƲƲ One-day training will be organized for syphilis programme at the
state level
ƲƲ One-day training will be organized for syphilis programme in every
district. ProgrammeManagers/ANMs/SNs/LHVs/LTs/MOs/OB-GYN/
Paediatricians/Pathologists/Microbiologists will attend

27
During Pregnancy
Sr.
No. Head
Unit Cost
(Rs.)
Number of
Participants Days
Total
(Rs.)
1 TA for participants (to and fro) –
to be given as per actuals
3,000 50 1,50,000
2 DA to trainees 700 50 1 35,000
3 Lunch and tea 200 50 1 10,000
4 Per diem/Honorarium for
trainers**
1,000 2 1 2,000
5 Logistic expenses such as for
study material, course material,
photocopying, job aids, flip
charts, LCD etc.
(Rate x days of training x
number of participants)
200 50 1 10,000
Sub-total 2,07,000
Incidental overheads
(10% of sub-total)
20,000
Total for one batch of 50
candidates for 1-day training
2,27,000
Sr.
No. Head
Unit Cost
(Rs.)
Number of
Participants Days
Total
(Rs.)
TA as per state norms
1 DA to District-level Programme
Officers
700 10 1 7,000
2 DA to Staff Nurses/ANM/LHV 400 25 1 20,000
3 DA to Medical Officers/Ob-Gyn 700 15 1 10,500
4. Lunch and tea 200 50 1 10,000
5 Honorarium to State-level Faculty** 1,000 2 1 2,000
6 Logistic expenses such as for
study material, course material,
photocopying, job aids, flip charts,
audio-visuals etc.
(Rate x number of participants)
200 50 - 10,000
Sub-total 49,500
Incidental overheads
(10% of sub-total)
5,000
Total for batch of 50 54,500
1-day Training at State Level for Syphilis - Batch of 50
1-day Training of District-level Officers for Syphilis - Batch of 50
Note:
** TA to be given as per state norms
The state needs to adjust the training norms as per the training load of the district and state
Budget:Training for Syphilis

28
During Pregnancy
Note:
◘◘ Every district programme officer needs to undertake advance planning and budget estimates for
universal screening of syphilis in the district.
◘◘ The state programme officer needs to reflect the budgetary requirement in the state/ NHM
Programme Implementation Plan (PIP).
◘◘ State/district accounts manager needs to ensure timely submission of utilisation certificates and
statements of expenditure.
◘◘ Necessary equipment/supplies either cash or in kind need to be made available in advance to
all the health care facilities in the district.
◘◘ Similarly, training institutes also need to be provided with the training budget as per the
estimates in advance.
◘◘ Any procurement that needs to be done should be through competitive and transparent bidding
process.

29
During Pregnancy
Annexures
Annexure – 1
Anaphylaxis Management
Before administrating penicillin drugs or injections, ask the patient about
previous allergies to penicillin.
Signs of possible Anaphylaxis
ƲƲ Shock
ƲƲ Difficulty in breathing
ƲƲ Itchy rash or hives (urticarial)
Management of Anaphylaxis
ƲƲ Call for help
ƲƲ Check
»» Airway
»» Breathing: Give mouth-to-mouth respiration, if necessary
»» Circulation: Perform cardiopulmonary resuscitation, if necessary
ƲƲ If Anaphylaxis, give Adrenaline intramuscularly (IM)
»» Dosage: Adult 0.5 mL (if elderly, 0.3 mL), repeat every 5–10 minutes
until adequate response
»» Check blood pressure and pulse every 5–10 minutes
ƲƲ Give Hydrocortisone. Dosage: Adult 250 mg IM
ƲƲ Give Chlorpheniramine. Dosage: 10–20 mg or Diphenhydramine
50–100 mg IM
ƲƲ Transfer patient to hospital
»» Repeat Adrenaline injection if necessary. Take extra doses with you
»» Record all details of treatment. Give a copy to the hospital as well as to
the patient
»» Stay with the patient until another doctor takes over care in person

30
During Pregnancy
Annexure – 2
Technical Specifications of Rapid Plasma Reagin (RPR) Test Kits
for Syphilis Testing
ƲƲ The indigenous RPR kits should have been manufactured under
manufacturing licence issued by the State Licensing Authority under
the Drugs and Cosmetics Act. The imported kits should have been
imported under import licence issued by the DCG (I) under the Drugs
and Cosmetics Act.
ƲƲ The assay should allow for qualitative and semi-quantitative
determination of reagin antibodies in serum or plasma for serological
diagnosis of syphilis based on flocculation principle using non-
treponemal antigens.
ƲƲ The assay should be suitable to perform with either serum or plasma.
ƲƲ The assay should have sensitivity of 80% or more in primary syphilis and
a specificity of 90% or more.
ƲƲ The assay should be calibrated to WHO reference serum and the same
should be supported by statements in kit inserts and certificate from
manufacturer.
ƲƲ The test should be able to yield results within 20 minutes.
ƲƲ The pack size of RPR test kit should be less than or equal to 50 tests
per kit.
ƲƲ The assay components should include positive and negative serum
controls sufficient for conducting 20% of the tests (10% negative and
10% positive controls).
ƲƲ The kit should have all essential accessories required for the test such
as cards, dropper, accelerator, etc., in adequate quantities for the
number of tests to be performed.
ƲƲ The kit should have 5/6th of the shelf life or 12 months before expiry
(whichever is more) at the time of receipt by the consignee.
ƲƲ The kit should have a storage temperature of 2°C to 8°C and supplier/
local agent should have the facility to store kits at 2°C to 8°C.
ƲƲ Cumulative Time Temperature Indicator should be part of the kit and the
indicator technology used should be prequalified by WHO.
ƲƲ Literature detailing the components, methodologies, validity criteria,
performance characteristics, storage conditions, manufacturing and
expiry dates should be provided with each kit.

31
During Pregnancy
Annexure – 3
Technical Specifications of Treponemal-specific Rapid (Point-of-
Care) Diagnostic Test for Syphilis
ƲƲ The assay should have solid phase coated with synthetic or recombinant
type of Treponema Pallidum antigens.
ƲƲ The assay may be based on any of the rapid test principles:
(Immunoconcentration/Dot blot immunoassay (vertical flow), dip stick and
comb assay.
ƲƲ The assay should quantitatively detect total anti-treponemal antibody (IgG
and IgM) in whole blood, serum or plasma for serological diagnosis of
syphilis in all stages of infection.
ƲƲ The assay should have an in-built positive and negative control for testing
the validity of the test kits.
ƲƲ The assay should have reactive and non-reactive controls with each kit in
adequate volume (minimum 10% of pack size).
ƲƲ The kit should have 5/6th
of the shelf life or 12 months before expiry
(whichever is more) at the time of receipt by the consignee.
ƲƲ Adequate literature detailing the principle, components, methodologies,
validity criteria, bio-safety, performance characteristics, storage
conditions, limitation of assay, manufacture and expiry dates and
methods of disposal should be provided with each kit.
ƲƲ The imported rapid kit should have approval of the statutory authority in
its country of origin. The imported kits should have been registered and
licensed in India by the Central Drugs Standard Control Organization
(CDSCO).
ƲƲ In case of indigenous manufacturers they should have a valid licence
issued by the competent authority defined under Drugs and Cosmetics
Act, 1940, after appropriate evaluation by the centres approved by the
CDSCO.
ƲƲ The assay should have sensitivity of 90% or more and specificity of 95%
or more and the same should be supported by statements in kit insert and
certificate from National Institute of Biological Sciences.
ƲƲ The assay should be calibrated to WHO reference serum and the same
should be supported by statements in kit insert and certificate from the
manufacturer.

32
During Pregnancy
ƲƲ The manufacturer should ensure the following:
»» The test should be packed such that there is a provision to conduct
single test at a time.
»» The pack size of test kits should be in 50 (for peripheral health levels)
and 100 tests per kit (for secondary and tertiary health care level) but
not more than 100 tests per kit.
ƲƲ The manufacturer/authorized agent should ensure maintenance of cold
chain during storage and transport of kits at 2°C to 8°C.
ƲƲ Total procedure time should not be more than 30 minutes.

33
During Pregnancy
Annexure – 4
Referral Slip
Name of referring facility: _________________________________________
Address: __________________________________Telephone:___________
Name of the patient: _____________________________________________
Father’s/Husband’s name: ___________________________________
Contact no.:_________
Address: ____________________________
Referred on ____/____/____ (dd/mm/yy_________ (time) to_________
_______________________________(name of the facility) for management.
Provisional diagnosis: __________________________
Summary of management:_______________________
Blood group: ________________ Hb:_____
Status of Syphilis: ______________
Other investigations: __________
Procedures and critical interventions carried out
Treatment given: __________________
Dose of penicillin: ___________ Duration:_______________________
Condition at time of referral: _________
Consciousness: Temp: ________ Pulse:_________ BP:____________
Reason for referral:
Mode of transport for referral: Govt./PPP/Vehicle arranged by patient
Telephonic information on referral provided to the institution referred to: No/
Name of the person spoken to: _________________________________
Signature of referring physician/health functionary:
Name/Designation/Stamp:

34
During Pregnancy
Annexure – 5
Migration Form for Pregnant Women with Syphilis
Name:________________________________________________________
Husband’s/Father’s name:________________________________________
Present address: _______________________________________________
_____________________________________________________________
Name of Health Facility attended:__________________________________
Migration address:______________________________________________
_____________________________________________________________
Address of health facility to be attended:_____________________________
_____________________________________________________________
Diagnosis of Syphilis:______________________Date:______________
Period of gestation: ________weeks___________________
Treatment given:_______________________________________________
____________________________________________________________
Information about migration given to:
Name:_______________________________________________________
Designation:__________________________________________________
Mobile no./Telephone no:________________________________________
Place of work:_________________________________________________
Signature of Doctor

35
During Pregnancy
Annexure – 6
Monthly Syphilis Reporting Format for State & District
Programme Managers for month of ...........……………year………...
Name of State:____________________Name of District:________________
Estimated number of pregnant women:______________________________
Estimated number of deliveries:____________________________________
ƲƲ Total number of ANC conducted (including all 4 ANC visits) in reporting
month:_______________
ƲƲ Number of syphilis-positive pregnant women diagnosed out of total
number of ANC conducted in the reporting month:________________
ƲƲ Total number of pregnant women who received adequate treatment
(i.e. received one dose of benzathine penicillin injection) for syphilis
out of total number of syphilis-positive women diagnosed in reporting
month:_______________
ƲƲ Number of confirmed cases of congenital syphilis out of total number
of syphilis-positive pregnant women who delivered in the reporting
month:_______________
ƲƲ Number of babies who received treatment who are born to syphilis-
positive mothers out of total number of syphilis-positive pregnant women
diagnosed in reporting month:_________________
Note:
◘◘ Districts will report to their states.
◘◘ Information will be compiled at state level to forward to GOI.

36
During Pregnancy
Annexure – 7
Monthly Syphilis Reporting Format for Health Facility for
Month of …………………, Year………………
Name of State:___________________Name of District:_________________
Name of Health Facility:__________________________________________
Estimated number of pregnant women:______________________________
Estimated number of deliveries:____________________________________
ƲƲ Total number of ANC conducted (including all 4 ANC visits) in reporting
month:________________
ƲƲ Number of syphilis-positive pregnant women diagnosed out of total
number of ANC conducted in the reporting month:__________________
ƲƲ Total number of pregnant women received adequate treatment (i.e.
received one dose of benzathine penicillin injection) for syphilis out
of total number of syphilis-positive women diagnosed in reporting
month:_________________
ƲƲ Number of confirmed cases of congenital syphilis out of total number
of syphilis-positive pregnant women who delivered at the facility in the
reporting month:__________________
ƲƲ Number of babies who received treatment who are born to syphilis-
positive mothers out of total number of syphilis-positive pregnant women
who delivered in reporting month:____________________
Note:
◘◘ Health facility will report to District.
◘◘ Information will be compiled at district level for forwarding to state.

37
During Pregnancy
References
ƲƲ World Health Organization. The Global Elimination of Congenital Syphilis:
Rationale and Strategy for Action. Geneva, World Health Organization,
2007
ƲƲ Investment Case for Eliminating Mother to Child Transmission of Syphilis:
Promoting Better Maternal and Child Health and Stronger Health Systems,
WHO Publications, 2012
ƲƲ Eliminating Congenital Syphilis in South East Asia Region - A Feasible
Strategic Initiative 2011–2015; WHO Publication, 2012
ƲƲ HIV Sentinel Surveillance Data for 2010–11, NACO
ƲƲ Report on Global Sexually Transmitted Infection Surveillance, WHO
Publications, 2013
ƲƲ Singh AE, Romanowski B. Syphilis: Review with Emphasis on Clinical,
Epidemiologic and Some Biologic Features. Clinical Microbiological
Review, 1999, 12:187–209
ƲƲ Brion LP et al. Long Bone Radiographic Abnormalities as a Sign of Active
Congenital Syphilis in Asymptomatic Newborns. Paediatrics, 1991.
ƲƲ Davanzo R et al. Neonatal and Post-neonatal Onset of Early Congenital
Syphilis: A Report from Mozambique. Annals of Tropical Paediatrics, 1992,
12:445–450.
ƲƲ Centre for Disease Control (CDC), STD Surveillance Case Definitions, STD
Surveillance, 2010
ƲƲ Centre for Disease Control, MMWR, 2010, weekly/Vol.59/No.14,
April 16, 2010.
ƲƲ National STI Guidelines.
ƲƲ Tais F. Galvao1, Marcus T. et al. Safety of Benzathine Penicillin for
Preventing Congenital Syphilis: A Systematic Review. PLOS ONE,
February 2013, Vol.8/No.2.
ƲƲ Central Drugs Standard Control organization, DGHS, MoHFW, Govt. of
India. http://www.cdsco.nic.in/writereaddata/National%20List%20of%20
Essential%20Medicine-%20final%20copy.pdf (accessed on June 20, 2014)
ƲƲ Operational Guidelines for ePTCT of Syphilis. NACO, 2014.
ƲƲ Guidelines for Community Process, National Rural Health Mission, June
2013
ƲƲ World Health Organization. Model List of Essential Medicines 17th
edition. Geneva. WHO 2011; Available from http://www.who.int/medicines/
publications/essentialmedicines/en/index.html
ƲƲ World Health Organization. Methods for Surveillance and Monitoring of
Congenital Syphilis Elimination within Existing Systems. 2011.

42
During Pregnancy
Government of India
Nirman Bhawan, New Delhi-110011
Website: www.mohfw.gov.in & www.nhm.gov.in

Syphilis screening in pw 5th jan

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