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An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02410655
Enrollment
0
Registered
2015-04-07
Start date
2015-11-30
Completion date
2017-07-27
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage, Uterine Atony

Keywords

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

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.

Interventions

DRUGOxytocin

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Vaginal Delivery

Exclusion criteria

* Cesarean Delivery * Allergy to Oxytocin * Cardiac Arrhythmia

Design outcomes

Primary

MeasureTime frame
Estimated blood loss24 hours postpartum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026