Clinical Trials Directory

Trials / Completed

CompletedNCT00473707

Active Versus Expectant Management of the Third Stage of Labor

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
218 (actual)
Sponsor
Christiana Care Health Services · Academic / Other
Sex
Female
Age
16 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREActive management of the third stage of laborstandardized 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
PROCEDUREExpectant management of the third stage of laborstandardized 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
DRUGOxytocin and gentle cord traction with fundal massagestandardized 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
DRUGOxytocinstandardized 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

Timeline

Start date
2002-08-01
Primary completion
2006-07-01
Completion
2006-07-01
First posted
2007-05-15
Last updated
2023-04-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00473707. Inclusion in this directory is not an endorsement.