An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

NCT ID: NCT02410655

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-07-27

Brief 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

Keywords

Uterine atony; Postpartum hemorrhage; Vaginal delivery; Uterotonic; Oxytocin; Bolus; Evidence-based; Protocol

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional standard of care

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

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.

Evidence based protocol

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pitocin; Pitocin

Eligibility Criteria

Inclusion Criteria

• Vaginal Delivery

Exclusion Criteria

• Cesarean Delivery
• Allergy to Oxytocin
• Cardiac Arrhythmia

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Violetta Lozovyy, MD

Role: PRINCIPAL_INVESTIGATOR

Lutheran Medical Center

Jade King, BS

Role: PRINCIPAL_INVESTIGATOR

Lutheran Medical Center

Roulhac D Toledano, MD, PhD

Role: STUDY_DIRECTOR

Lutheran Medical Center

Kevin Fitzpatrick, MD

Role: STUDY_CHAIR

Lutheran Medical Center

Other Identifiers

16-00279

Identifier Type: -

Identifier Source: org_study_id

NCT02453568

Identifier Type: -

Identifier Source: nct_alias