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Active Versus Expectant Management of the Third Stage of Labor

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active management of the third stage of labor
Expectant management of the third stage of labor
Oxytocin and gentle cord traction with fundal massage
Oxytocin
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Third stage of labor

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

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

Expectant management of the third stage of labor

Outcomes

Primary Outcome Measures

Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater

Secondary Outcome Measures

Mean change in hematocrit from before delivery to the first postpartum day
Rate of maternal blood transfusion
Duration of the third stage of labor
Incidence of retained placenta

Full Information

First Posted
May 14, 2007
Last Updated
April 11, 2023
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00473707
Brief Title
Active Versus Expectant Management of the Third Stage of Labor
Official Title
A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Third stage of labor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage
Arm Title
2
Arm Type
Other
Arm Description
Expectant management of the third stage of labor
Intervention Type
Procedure
Intervention Name(s)
Active management of the third stage of labor
Intervention Description
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
Intervention Name(s)
Expectant management of the third stage of labor
Intervention Description
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
Intervention Name(s)
Oxytocin and gentle cord traction with fundal massage
Intervention Description
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
Intervention Name(s)
Oxytocin
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater
Time Frame
reported immediately after delivery
Secondary Outcome Measure Information:
Title
Mean change in hematocrit from before delivery to the first postpartum day
Time Frame
24 hours
Title
Rate of maternal blood transfusion
Time Frame
48 hours
Title
Duration of the third stage of labor
Time Frame
60 minutes
Title
Incidence of retained placenta
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle E Castagnola, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

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Active Versus Expectant Management of the Third Stage of Labor

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