Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2008 |
| End Date: | June 2010 |
Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose
oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony
and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the
uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of
maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and
effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not
known.
oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony
and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the
uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of
maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and
effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not
known.
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon
recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member
DSMB in January of 2010 and their recommendations were implemented.
recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member
DSMB in January of 2010 and their recommendations were implemented.
Inclusion Criteria:
- > 24 weeks, viable pregnancy, singleton or twins
Exclusion Criteria:
- No consent
- Contraindication to oxytocin
- Antepartum fetal demise
- Intrapartum use of concentrated oxytocin
- Planned cesarean
- DIC or coagulopathy
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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