Active Versus Expectant Management of the Third Stage of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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<br>Drug: Oxytocin and gentle cord traction with fundal massage<br>* 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<br>|
| Other: 2<br>Expectant management of the third stage of labor | Procedure: Expectant management of the third stage of labor<br>* 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<br>Drug: Oxytocin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater |  | reported immediately after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in hematocrit from before delivery to the first postpartum day |  | 24 hours | 
| Rate of maternal blood transfusion |  | 48 hours | 
| Duration of the third stage of labor |  | 60 minutes | 
| Incidence of retained placenta |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Third stage of labor