Maternal Genitourinary Infections and Adverse Perinatal Outcomes

Summary

The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district, Bangladesh.

Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent score \>4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the population rate of preterm live birth by at least 15%.

The secondary aims of this study are:

* To determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections on the:

* proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and preterm live birth); and
* proportion of babies with early onset neonatal sepsis.
* To determine the prevalence of abnormal vaginal flora and urinary tract infections, including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.
* To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for detecting bacterial vaginosis and urinary tract infections by community health workers in a rural, developing country setting.

Conditions

• Maternal Infection Affecting Newborn

Interventions

OTHER

Screening treatment and referral

Women who are symptomatic at any study visit will be immediately referred to the sub-district hospital for full evaluation and treatment and will be visited on the following day to follow clinical status and ensure referral compliance. Referral will be reinforced by arranging transportation to the sub-district hospital and payment of hospital fees if the family is unable to afford out-of-pocket expenses. CHWs will conduct a home visit to women with positive test results within 24 hours of receiving the results to initiate treatment. All asymptomatic women will be treated for positive test results. For symptomatic women, the CHW will confirm the woman's clinical and treatment status, and provide treatment to those women who have not already received the appropriate treatment at the sub-district hospital for their infection. Antibiotic Treatment Regimens AVF: Oral clindamycin 300 mg per oral (po) twice daily (bid) for 5 days.UTI: Macrobid/Nitrofurantoin 100 mg po bid x 7 days.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• United States Agency for International Development (USAID)

  collaborator FED

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Abdullah H Baqui, MBBS, MPH, DrPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

47 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2016-03-17

Completion

2016-03-17

Countries

• Bangladesh

Study Locations