Active Versus Expectant Management of the Third Stage of Labor

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473707
• Other study ID #: 26008
• Status: Completed
• Phase: N/A
• Start date: August 2002
• Est. completion date: July 2006

Study information

• Verified date: April 2023
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• 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
• 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

Drug:
• 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
• 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

Locations

Country	Name	City	State
United States	Christiana Care Health System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater		reported immediately after delivery
Secondary	Mean change in hematocrit from before delivery to the first postpartum day		24 hours
Secondary	Rate of maternal blood transfusion		48 hours
Secondary	Duration of the third stage of labor		60 minutes
Secondary	Incidence of retained placenta		30 minutes