We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Perinatal Infections in Pakistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00070746
Recruitment Status : Completed
First Posted : October 10, 2003
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bacterial Vaginosis Fetal Membranes, Premature Rupture Chorioamnionitis Pregnancy

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.

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Time Perspective: Prospective
Official Title: Perinatal Infections and Pregnancy Outcomes in Pakistan: A Collaborative Research Project in Partnership With the University of Alabama, USA
Study Start Date : June 2003
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070746

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
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Alabama at Birmingham
Aga Khan University
Principal Investigator: Robert Goldenberg, MD Drexel University
More Information

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2003    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

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

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