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High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth

NCT ID: NCT06550089

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-12-31

Brief Summary

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This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

Detailed Description

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Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon.

The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).

Conditions

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Postpartum Hemorrhage Pregnancy Complications Cesarean Section Complications

Keywords

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oxytocin cesarean delivery postpartum hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High-dose oxytocin

900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.

Low-dose oxytocin

For unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.

Interventions

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Oxytocin

Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 or greater
* English or Spanish speaking
* Individuals undergoing a scheduled or unscheduled cesarean delivery

Exclusion Criteria

* Patient on therapeutic anticoagulation
* Patient with hypertensive disorder of pregnancy or chronic hypertension
* Patient with preexisting bleeding disorder
* Patient with preexisting cardiac disease
* Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
* Patient undergoing planned cesarean hysterectomy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashish Premkumar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Anna Palatnik, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Other Identifiers

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IRB24-0398

Identifier Type: -

Identifier Source: org_study_id