Infections of female genital tract

Completed

Conditions: Reproductive tract infections (RTI)/Sexually transmitted infections (STI)

Registration Number: CTRI/2020/03/023954

Lead Sponsor: Centre for Health Research and Development Society for Applied Studies

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 440

Inclusion Criteria

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.

Exclusion Criteria

Non consent for participation.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Assess the diagnostic validity of the current	RTI/STI diagnostic and management practice
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

Trial Locations

Locations (1): Centre for Health Research and Development, Society for Applied Studies
🇮🇳
South, DELHI, India
Centre for Health Research and Development, Society for Applied Studies
🇮🇳South, DELHI, India
Dr Sarmila Mazumder
Principal investigator
011-46043751
sarmila.mazumder@sas.org.in