Perinatal Infections in Pakistan - Article
Clinical Trial: Perinatal Infections in Pakistan
This study is currently recruiting patients.
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.
|Bacterial Vaginosis |
Fetal Membranes, Premature Rupture
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
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.
Genders Eligible for Study: Female
Accepts Healthy Volunteers
- 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.
- have clinical diagnoses of life-threatening conditions (requiring immediate treatment or hospitalization, as diagnosed by the attending physician).
Location and Contact Information
Health clinic, Hyderabad, Pakistan; Recruiting
Robert Goldenberg, M.D., Principal Investigator
Robert Goldenberg, MD, Principal Investigator, University of Alabama, Birmingham
Website for the Global Network for Women's and Children's Health Research.
Research Triangle Institute International
Aga Khan University, Pakistan
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
Cache Date: April 9, 2005