Clinical Trial: Perinatal Infections in Pakistan

This study is currently recruiting patients.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Alabama, Birmingham
Aga Khan University, Pakistan
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition
Bacterial Vaginosis
Fetal Membranes, Premature Rupture
Chorioamnionitis
Pregnancy

MedlinePlus related topics:  High Risk Pregnancy;   Vaginal Diseases

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

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

Further Study Details: 

Expected Total Enrollment:  3000

Study start: June 2003;  Expected completion: January 2006
Last follow-up: July 2005;  Data entry closure: October 2005

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 main hypothesis of the study is that bacterial vaginosis (BV) is associated with adverse pregnancy outcomes. The overall goal of this research is 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 3,000 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 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. Primary outcome is perinatal mortality. Secondary outcomes include birth weight; spontaneous delivery occurring before 37 weeks gestation; rupture of fetal membranes before 37 weeks of gestation; and maternal death. The sample size was based on 25% prevalence of BV in the control group; 10 percent dropout rate; 80 percent power; and a two-tailed type I error of 0.05.

Eligibility

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 in Karachi, Pakistan; 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).

Location and Contact Information

Nancy Moss, Ph.D.       mossn@mail.nih.gov

Pakistan
      Health clinic, Hyderabad,  Pakistan; Recruiting
Imtiaz Jehan, MD   imtiaz.jehan@aku.edu 
Robert Goldenberg, M.D.,  Principal Investigator

Study chairs or principal investigators

Robert Goldenberg, MD,  Principal Investigator,  University of Alabama, Birmingham   

More Information

Website for the Global Network for Women's and Children's Health Research.

Research Triangle Institute International

Aga Khan University, Pakistan

Study ID Numbers:  GN 09; U01 HD40607
Record last reviewed:  December 2004
Last Updated:  December 10, 2004
Record first received:  October 7, 2003
ClinicalTrials.gov Identifier:  NCT00070746
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005