Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05245227 |
| Other study ID # |
IRB2021-00142 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
February 2022 |
| Source |
Stony Brook University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To determine the effectiveness of using two medications simultaneously versus one medication,
as is standard of care, in preventing early postpartum hemorrhage.
There have been studies that looked at giving two medications and that there were reduced
odds of postpartum hemorrhage.
Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and
oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.
Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic
agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).
Description:
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the
world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be
attributed to uterine atony, failure of the uterus to contract in the immediate postpartum
period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical
management of the third stage of labor (the period between delivery of the infant and
placenta) and the administration of uterotonic agents (medication that induces uterine
contraction). Universal standard of care to prevent postpartum hemorrhage, according to the
American College of Obstetrics and Gynecologists and World Health Organization includes
various dose infusions of oxytocin. Additional uterotonics are given if necessary, according
to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose,
however, remain actively debated. Randomized controlled trials have not proven that
misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a
medication that is often used conjunctively or after other agents fail. A Cochrane review of
treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e.,
methergine), and combined oxytocin-ergot alkaloid administration were equally effective in
preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e.,
misoprostol) were not. In an effort to determine the benefit of a simultaneous double
uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a
controlled trial in which women will be randomly assigned to an intervention group (buccal
misoprostol and intravenous oxytocin administered simultaneously) versus a control group
(standard of care, intravenous oxytocin alone).
