NCT02410655

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

Detailed description

A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.

Conditions

• Uterine Atony
• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Oxytocin	500 mL bag of oxytocin (30 IU / 500 mL) to be connected to the IV, and controlled at the obstetricians request. Up to two, 50 mL rapid infusion boluses to be given after delivery of anterior shoulder. Upon completing the bolus(es) flow rate should be continued at 100 mL / hour. This should total no more than 4.5 hours.
DRUG	Oxytocin	A total of two 1000 mL bags of oxytocin (20 IU/ 1000 mL) are to be connected to the IV sequentially, and controlled at the obstetricians request, are each to be administered over 8 hours after delivery of anterior shoulder in vaginal delivery. This will total 16 hours of oxytocin infusion.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-27
• Completion: 2017-07-27
• First posted: 2015-04-07
• Last updated: 2017-07-31