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CTRI Number  CTRI/2020/03/023954 [Registered on: 13/03/2020] Trial Registered Prospectively
Last Modified On: 02/08/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Infections of female genital tract  
Scientific Title of Study
Modification(s)  
A study on reproductive tract infections / sexually transmitted infections among urban and peri urban women in North India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarmila Mazumder  
Designation  Senior Scientist and Senior Deputy Director  
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies 45 Kalu Sarai, New Delhi 110016, India

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Neeta Dhabhai 
Designation  Senior Clinical Research Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies 45 Kalu Sarai, New Delhi 110016, India

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  CHRD@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Neeta Dhabhai 
Designation  Senior Clinical Research Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies 45 Kalu Sarai, New Delhi 110016, India

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  CHRD@sas.org.in  
 
Source of Monetary or Material Support  
Department of Reproductive Health and Research (includes HRP – the UNDP/UNFPA/UNICEF/ WHO/ World Bank Special Programme of Research in Human Reproduction World Health Organization 20 Avenue Appia 1211 Geneva Switzerland 
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi - 110016 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarmila Mazumder  Centre for Health Research and Development, Society for Applied Studies  680, Nai Basti, Devli Gaon, Khanpur, 110062 New Delhi, Delhi
South
DELHI 
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Society for Applied Studies, Ethics Review Committee  Approved 
World Health Organisation, Ethics Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Reproductive tract infections (RTI)/Sexually transmitted infections (STI) 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Women enrolled in WINGS at the time of exit, that is, 18 months since enrolment in WINGS.

24 months after delivery for women with live birth
 
 
ExclusionCriteria 
Details  Non consent for participation  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To determine the prevalence of laboratory confirmed RTI/STIs (Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Candida albicans and bacterial vaginosis among symptomatic and asymptomatic women of reproductive age group (WRA) participating in WINGS.  Atleast 14 days after their exit from the primary trial WINGS, for 2 groups of women
- Women who complete 18 months of the pre and peri-conception phase without getting pregnant
- Women with live birth, when the child is aged 24 months.
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Assess the diagnostic validity of the current
RTI/STI diagnostic and management practice
(i.e., RTI/STI syndromic case management)
in the WINGS relative to the gold standard etiologic diagnosis based on laboratory confirmation of RTI/STI) among women having
of symptoms of RTI/STI
 
Atleast 14 days after their exit from the primary trial WINGS, for 2 groups of women
- Women who complete 18 months of the pre and peri-conception phase without getting pregnant
- Women with live birth, when the child is aged 24 months.
 
To identify demographic, behavioural, sexual and clinical factors associated with laboratory confirmed RTI/STI among women with symptoms such as vaginal discharge, itching and burning, rashes, pain lower abdomen, dyspareunia, ulcer or sore and swelling.  Atleast 14 days after their exit from the primary trial WINGS, for 2 groups of women
- Women who complete 18 months of the pre and peri-conception phase without getting pregnant
- Women with live birth, when the child is aged 24 months.
 
 
Target Sample Size   Total Sample Size="440"
Sample Size from India="440" 
Final Enrollment numbers achieved (Total)= "440"
Final Enrollment numbers achieved (India)="440" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/03/2020 
Date of Study Completion (India) 20/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

RTI/STI are major public health problems in India. RTIs/STIs are associated with infertility, causing damage, inflammation, adhesions, lacerations or obstructions to the cervix, tubes and peritoneumFurthermore, STIs such as syphilis, gonorrhoea, and chlamydial infections in pregnancy can cause premature rupture of membranes, low-birth-weight and prematurity, neonatal sepsis, neonatal conjunctivitis, and congenital infections and deformities. STIs increase the risk of HIV acquisition, and significantly affect the quality of life due to various symptoms, including itching, discharge, dyspareunia, lower abdominal pain and infertility. In India we do not have enough information on causative organism of RTI/STI. The government guidelines recommend treatment based on symptoms and signs of RTI/ STI.  Asymptomatic women may also suffer from these infections, which they may not be aware of.

This will be a cross-sectional study that aims to determine the prevalence of laboratory confirmed RTI/STI among symptomatic and asymptomatic women of reproductive age group, assess the diagnostic validity of the syndromic case management approach and identify demographic, behavioural, sexual and clinical factors associated with laboratory confirmed RTI/STI among women with infections. Women enrolled in WINGS will be invited to participate in this study atleast 14 days after their their exit from the WINGS on completion of 18 months follow up period among those who do not become pregnant and at completion of 24 months among women who delivered a live birth. After obtaining written informed consent, women will be asked about symptoms, examined for signs in both symptomatic and asymptomatic women and high vaginal and endocervical swabs specimens will be collected to confirm the etiological diagnosis. Samples will be analysed in an NABL accredited laboratory. A questionnaire will be administered to collect information on predefined baseline characteristics.

Women with signs and symptoms of STI/RTI will be treated based on the syndromic approach as recommended in national guidelines. Women will be revisited after the laboratory reports are received and will be treated accordingly. Women will be provided information on RTI/STI and counselled on prevention of these infections. Some women who may require admission or need some procedures will be referred to Safdarjung hospital (tertiary care government hospital) for further management. A complete course of treatment and supply of condom will be provided for free.   


The study will provide useful information on the prevalence of signs, symptoms and etiological diagnosis of RTIs/STIs in symptomatic and asymptomatic women of reproductive age group. The results of the study will provide insights to plan program to diagnose, prevent and control such infections.

 
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