Active Versus Expectant Management of the Third Stage of Labor

• Sponsor: Christiana Care Health Services (Other)
• Overall Status: Completed
• CT.gov ID: NCT00473707
• Collaborator: (none)
• Enrollment: 218
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 4.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Procedure: Active management of the third stage of labor; Procedure: Expectant management of the third stage of labor; Drug: Oxytocin and gentle cord traction with fundal massage; Drug: Oxytocin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor
• Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage	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; 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
Other: 2 Expectant management of the third stage of labor	Procedure: 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; 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

Outcome Measures

Primary Outcome Measures

1. Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater [reported immediately after delivery]

Secondary Outcome Measures

1. Mean change in hematocrit from before delivery to the first postpartum day [24 hours]

2. Rate of maternal blood transfusion [48 hours]

3. Duration of the third stage of labor [60 minutes]

4. Incidence of retained placenta [30 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health System	Newark	Delaware	United States	19718

Sponsors and Collaborators

• Christiana Care Health Services

Investigators

• Principal Investigator: Danielle E Castagnola, MD, Christiana Care Health Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00473707
• Other Study ID Numbers: 26008
• First Posted: May 15, 2007
• Last Update Posted: May 15, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Third stage of labor
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Oxytocin

Study Results

No Results Posted as of May 15, 2008