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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Reproductive tract infections (RTI)/Sexually transmitted infections (STI) |
|
Intervention / Comparator Agent
|
|
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 peritoneum. Furthermore, 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. |