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Active Versus Expectant Management of the Third Stage of Labor

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00473707
First received: May 14, 2007
Last updated: May 14, 2008
Last verified: May 2008
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater [ Time Frame: reported immediately after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in hematocrit from before delivery to the first postpartum day [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Rate of maternal blood transfusion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Duration of the third stage of labor [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Incidence of retained placenta [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: August 2002
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473707

Locations
United States, Delaware
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
  More Information

No publications provided

Responsible Party: Danielle Castagnola, Christiana Care Health System
ClinicalTrials.gov Identifier: NCT00473707     History of Changes
Other Study ID Numbers: 26008
Study First Received: May 14, 2007
Last Updated: May 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Third stage of labor

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014