An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

Official title:

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02410655
• Other study ID #: 16-00279
• Status: Withdrawn
• Phase: Phase 4
• First received: April 2, 2015
• Last updated: July 27, 2017
• Start date: November 2015
• Est. completion date: July 27, 2017

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02453568

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Vaginal Delivery

Exclusion Criteria:

• Cesarean Delivery

• Allergy to Oxytocin

• Cardiac Arrhythmia

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss		24 hours postpartum