Active Versus Expectant Management of the Third Stage of Labor

Christiana Care Health Services

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Procedure: Expectant management of the third stage of labor; Drug: Oxytocin; Procedure: Active management of the third stage of labor; Drug: Oxytocin and gentle cord traction with fundal massage

Study type: Interventional

Funder types: Other

Identifiers

NCT00473707

26008

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Oxytocin and gentle cord traction with fundal massage

Procedure: Active management of the third stage of labor

2

Other group

Description:

Expectant management of the third stage of labor

Treatment:

Drug: Oxytocin

Procedure: Expectant management of the third stage of labor