Trial Information

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

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.