Active Versus Expectant Management of the Third Stage of Labor

April 11, 2023 updated by: Christiana Care Health Services

A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor

The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum hemorrhage is the leading cause of maternal mortality worldwide. During the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. Controversy remains as to the optimal method of delivering the placenta. Two predominant, yet very different, strategies have emerged. Expectant management is most commonly used in the United States. This includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. Then uterotonic agents are administered,usually oxytocin. This is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. This is the predominant practice in the United Kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine.

Comparison: Active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Singleton gestation
  • Cephalic presentation
  • >37 weeks gestation
  • >16 years of age

Exclusion Criteria:

  • Multiple gestation
  • Breech presentation
  • Blood dyscrasias
  • Multiparous females Para >5
  • Placenta previa
  • Patients on anticoagulants
  • Previous history of postpartum hemorrhage
  • IUFD
  • Non-reassuring fetal heart rate pattern

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage
Procedure: Active management of the third stage of labor
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
Drug: Oxytocin and gentle cord traction with fundal massage
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
Other: 2
Expectant management of the third stage of labor
Procedure: Expectant management of the third stage of labor
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
Drug: Oxytocin
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater
Time Frame: reported immediately after delivery
reported immediately after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in hematocrit from before delivery to the first postpartum day
Time Frame: 24 hours
24 hours
Rate of maternal blood transfusion
Time Frame: 48 hours
48 hours
Duration of the third stage of labor
Time Frame: 60 minutes
60 minutes
Incidence of retained placenta
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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