The study's goal is to determine how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.

Condition
Bacterial Vaginosis Fetal Membranes, Premature Rupture Chorioamnionitis

This project, part of the National Institute of Child Health and Human Development (NICHD) Global Network for Research on Women’s and Children’s Health, is aimed at improving maternal and child survival in Pakistan. The primary objective is to examine the association between bacterial vaginosis (BV) in pregnant women at 20-26 weeks gestation and various other biochemical infection markers with adverse pregnancy outcomes (i.e., perinatal mortality [PNM], neonatal mortality, low birth weight [LBW], spontaneous preterm delivery [SPTD], premature rupture of membranes [PROM], histological chorioamnionitis). Additionally, it will explore the relationship of various health behaviors and health status to the presence of perinatal infections. A total of 3,000 pregnant women will be enrolled in the study.

Based on the findings of this study, appropriate interventions to address reproductive tract infection (RTI) could be developed and field-tested in Pakistan. We expect that these interventions, once successfully field-tested, could be widely used to improve maternal and child survival in Pakistan and other developing countries. Given the critical state of maternal and child health in Pakistan, and considering the emerging evidence that infections could lead to poor pregnancy outcomes, this study is extremely relevant and timely, and it has the potential to contribute significantly toward the improvement of reproductive health in Pakistan.

Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Participants must

• be in their 20th to 26th week of pregnancy (to be confirmed by an ultrasound)
• be permanent residents (resident for the past months or intending to stay for next the 6 months) of the study site; and,
• give informed (written or verbal) consent.

Exclusion criteria:

• have clinical diagnoses of life-threatening conditions (requiring immediate treatment or hospitalization, as diagnosed by the attending physician).

Beth McClure, M.Ed.      919-485-5704    mcclure@rti.org
Vijaya Rao, Ph.D.      919-541-6374    rao@rti.org

Pakistan
      Health clinic, Hyderabad,  Pakistan; Recruiting

Study chairs or principal investigators

Nancy Moss, Ph.D.,  Study Chair,  National Institute of Child Health and Human Development (NICHD)   
Robert Goldenberg, MD,  Principal Investigator,  University of Alabama, Birmingham   

Study ID Numbers:  GN09
Record last reviewed:  October 2003
Record first received:  October 7, 2003
ClinicalTrials.gov Identifier:  NCT00070746
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08