Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116480
Status:
COMPLETED
Last Update Posted:
2009-03-19
First Post:
2005-06-29
Brief Title:
Misoprostol in the Treatment of Postpartum Hemorrhage
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
Misoprostol in the Treatment of Post Partum Hemorrhage A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Postpartum haemorrhage PPH remains a leading cause of maternal mortality despite treatment with conventional methods Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method In this randomised controlled trial RCT we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery and after routine syntocinon to all women during or after delivery has additional effects above the additional conventional uterotonics in reducing PPH Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH In addition they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment
Detailed Description:
None
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