Active Versus Expectant Management of the Third Stage of Labor

NCT ID: NCT00473707

Last Updated: 2023-04-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2006-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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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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1

Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage

Group Type ACTIVE_COMPARATOR

Active management of the third stage of labor

Intervention Type PROCEDURE

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

Oxytocin and gentle cord traction with fundal massage

Intervention Type DRUG

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

2

Expectant management of the third stage of labor

Group Type OTHER

Expectant management of the third stage of labor

Intervention Type PROCEDURE

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

Oxytocin

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Christiana Care Health System

Principal Investigators

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Danielle E Castagnola, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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26008

Identifier Type: -

Identifier Source: org_study_id

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