Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116350
Status:
COMPLETED
Last Update Posted:
2009-03-19
First Post:
2005-06-28
Brief Title:
Misoprostol for the Treatment of Postpartum Hemorrhage
Sponsor:
Gynuity Health Projects
Organization:
Gynuity Health Projects
Study Overview
Official Title:
Misoprostol for the Treatment of Primary Postpartum Hemorrhage
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:
The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage PPH with uterine atony as the suspected cause in two circumstances 1 where women have received prophylactic uterotonics in the third stage of labor and 2 where no prophylactic uterotonics have been given in the third stage of labor
Detailed Description:
Postpartum hemorrhage PPH remains a major cause of maternal deaths worldwide Misoprostol offers several advantages over oxytocin and ergometrine the drugs currently used to treat PPH For example misoprostol is stable at high temperatures and has a shelf life of several years it is easy to administer it can be given to hypertensive patients and it is inexpensive This randomized double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births both when women have received prophylactic uterotonics in the third stage of labor and when they have not
Blood loss will be measured for all consenting women who deliver vaginally If PPH occurs and uterine atony is the suspected cause women will be randomized to receive either a four 200 µg pills of misoprostol sublingually and an IV of saline resembling oxytocin or b four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV This study seeks to answer the following questions
Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor
Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH
Is the side effect profile of misoprostol acceptable to women
This study will take place in hospitals located in Burkina Faso Ecuador Egypt Turkey and Vietnam
Blood loss will be measured for all consenting women who deliver vaginally If PPH occurs and uterine atony is the suspected cause women will be randomized to receive either a four 200 µg pills of misoprostol sublingually and an IV of saline resembling oxytocin or b four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV This study seeks to answer the following questions
Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor
Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH
Is the side effect profile of misoprostol acceptable to women
This study will take place in hospitals located in Burkina Faso Ecuador Egypt Turkey and Vietnam
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 |
|---|---|---|---|
| WIRB 200418781063615 | None | None | None |