Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097123
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2004-11-17
Brief Title:
RCT of Misoprostol for Postpartum Hemorrhage in India
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
RCT of Misoprostol for Postpartum Hemorrhage in India
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:
Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States Bleeding after the birth of a child and underlying anemia are the primary causes of mothers deaths and sickness in rural India This study assesses the effectiveness of an oral drug misoprostol given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District Karnataka India
Detailed Description:
Despite existing knowledge of ways to effectively treat postpartum hemorrhage PPH lack of resources in rural India has impeded improvement in rates of maternal mortality and morbidity Most births take place at home and local auxiliary nurse midwives are not trained or certified to administer injectable uterotonics Reduction in postpartum hemorrhage may decrease other adverse maternal outcomes such as the need for additional uterotonic agents blood transfusion surgical intervention or death The main hypothesis of the study is that misoprostol administered orally during the third stage of labor will significantly reduce the incidence of acute postpartum hemorrhage The advantages of misoprostol are that it is relatively inexpensive is an oral preparation of 600 mcg with a long shelf life and does not require refrigeration One thousand six hundred women giving birth in selected sites in Belgaum District Karnataka India will be randomly assigned to misoprostol or placebo The primary outcome is the incidence of acute postpartum hemorrhage secondary outcomes include incidence of delayed postpartum hemorrhage and secondary infection transport to higher-level facility use of uterotonic agents blood transfusion and maternal mortality for 42 days A nested case-control analysis of women who experience acute severe postpartum hemorrhage compared to women who do not will identify socioeconomic behavioral cultural and systems factors associated with postpartum hemorrhage For purposes of this study acute PPH is defined as blood loss equal to or greater than 500 ml within 2 hours of delivery and acute severe PPH as blood loss equal to or greater than 1000 ml within 2 hours of delivery
The sample size was based on a decrease of 50 PPH in the treated versus the control group 20 rate of non-compliance power of 96 and a two-tailed type I error of 005
The sample size was based on a decrease of 50 PPH in the treated versus the control group 20 rate of non-compliance power of 96 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 |
|---|---|---|---|
| U01HD042372 | NIH | None | httpsreporternihgovquickSearchU01HD042372 |