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Completed

NCT Number: NCT00473707

Active Versus Expectant Management of the Third Stage of Labor

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

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active management of the third stage of labor

Procedure

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

Procedure

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

Oxytocin and gentle cord traction with fundal massage

Drug

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

Drug

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

Primary outcomes

  1. Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater

    Time frame: reported immediately after delivery

Secondary outcomes

  1. Mean change in hematocrit from before delivery to the first postpartum day

    Time frame: 24 hours

  2. Rate of maternal blood transfusion

    Time frame: 48 hours

  3. Duration of the third stage of labor

    Time frame: 60 minutes

  4. Incidence of retained placenta

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 15, 2007
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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