Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070746
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2003-10-07
Brief Title:
Perinatal Infections in Pakistan
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
Perinatal Infections and Pregnancy Outcomes in Pakistan A Collaborative Research Project in Partnership With the University of Alabama USA
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Pakistan the worlds 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 100000 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 ie 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 1500 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 005
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 ie 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 1500 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD040607 | NIH | None | httpsreporternihgovquickSearchU01HD040607 |