Active Versus Expectant Management of the Third Stage of Labor

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Procedure: Expectant management of the third stage of labor; Procedure: Active management of the third stage of labor; Drug: Oxytocin and gentle cord traction with fundal massage; Drug: Oxytocin

• Registration Number: NCT00473707
• Lead Sponsor: Christiana Care Health Services

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oxytocin and gentle cord traction with fundal massage	Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage
2	Expectant management of the third stage of labor	Expectant management of the third stage of labor
1	Active management of the third stage of labor	Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage
2	Oxytocin	Expectant management of the third stage of labor

Primary Outcome Measures

Name	Time	Method
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater	reported immediately after delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States