Perinatal Infections in Pakistan

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Aga Khan University
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00070746
First received: October 7, 2003
Last updated: July 29, 2014
Last verified: July 2014
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Perinatal Infections and Pregnancy Outcomes in Pakistan: A Collaborative Research Project in Partnership With the University of Alabama, USA

Further study details as provided by NICHD Global Network for Women's and Children's Health:

Estimated Enrollment: 1500
Study Start Date: June 2003
Estimated Study Completion Date: July 2005
Detailed Description:

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 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:   Yes
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 Hyderabad, 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070746

Locations
Pakistan
Health clinic
Hyderabad, Pakistan
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Aga Khan University
Investigators
Principal Investigator: Robert Goldenberg, MD Drexel University
  More Information

Additional Information:
No publications provided

Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00070746     History of Changes
Other Study ID Numbers: GN 09, U01HD040607
Study First Received: October 7, 2003
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Perinatal mortality [PNM]
Neonatal mortality
Low birth weight [LBW]
Spontaneous preterm delivery [SPTD]
Premature rupture of membranes [PROM]
Histological chorioamnionitis
Global Network
Pakistan
Maternal and child health
International
Women's health

Additional relevant MeSH terms:
Chorioamnionitis
Fetal Membranes, Premature Rupture
Vaginosis, Bacterial
Communicable Diseases
Fetal Diseases
Rupture
Pregnancy Complications
Obstetric Labor Complications
Placenta Diseases
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014