Clinical Trial: Perinatal Infections in Pakistan

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Perinatal Infections and Pregnancy Outcomes in Pakistan: A Collaborative Research Project in Partnership With the University of Alabama, USA

Brief Summary: There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.

Detailed Summary:

Pakistan, the world's seventh most populous country of about 138 million people, is beset with severe problems in its maternal and child health sector. The official maternal mortality ratio for Pakistan is reported as 340 per 100,000 live births.

The overall goal to conduct a prospective observational study to identify the risk factors for adverse pregnancy outcomes including reproductive tract infections such as BV, and other physical, dental, nutritional, psychosocial, and behavioral characteristics. The primary objective is to examine the association between 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, this study will explore the relationship of various health behaviors and health status to the presence of perinatal infections. A total of 1,500 pregnant women will be enrolled in the study. A matched case-control study will be conducted at the end of the data collection period to evaluate the use of markers for the prediction of infection related perinatal mortality and infection related SPTD. All investigators and laboratory personnel will remain blinded to the identity of specimens through the use of unique study identifier numbers. Collected data will then be unblinded, analysed, and correlated with the previously collected demographic, obstetrics, and neonatal outcome, microbiology and histopathological data.

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 interve
Sponsor: NICHD Global Network for Women's and Children's Health

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: NICHD Global Network for Women's and Children's Health

Dates:
Date Received: October 7, 2003
Date Started: June 2003
Date Completion: July 2005
Last Updated: July 29, 2014
Last Verified: July 2014