An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

NYU Langone Health

Status and phase: Withdrawn; Phase 4

Conditions: Uterine Atony; Postpartum Hemorrhage

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02410655

16-00279

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Vaginal Delivery

Exclusion criteria

• Cesarean Delivery
• Allergy to Oxytocin
• Cardiac Arrhythmia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Conventional standard of care

Active Comparator group

Description:

Traditional administration of oxytocin at Lutheran Medical Center involves the use of two 20 IU / 1000 mL bags hung sequentially at a flow rate of 125 mL / hour each after the delivery of the anterior shoulder. This will total no more than 16 hours.

Treatment:

Drug: Oxytocin

Drug: Oxytocin

Evidence based protocol

Active Comparator group

Description:

The proposed evidence based protocol involves utilizing a single 30IU / 500mL bag of oxytocin. After the delivery of the anterior shoulder, an initial rapid infusion bolus of 50mL of the 30IU / 500mL at 999mL / hour. Three minutes after rapid infusion, uterine tone should be assessed. If inadequate uterine tone persists, a second rapid infusion at the same dose and rate as above should be given. If inadequate uterine tone persists, a third rapid infusion may be given. If adequate uterine tone is achieved after any rapid infusion, the remainder of the bag should be administered at a rate of 100mL / hour until finished. If adequate tone is not achieved, the remainder of the bag should be administered at 100mL / hour and additional uterotonic agents should be considered.

Treatment:

Drug: Oxytocin

Drug: Oxytocin