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Active Versus Expectant Management of the Third Stage of Labor

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ClinicalTrials.gov Identifier: NCT00473707
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : May 15, 2008
Sponsor:
Information provided by:
Christiana Care Health Services

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : August 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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

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




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Danielle Castagnola, Christiana Care Health System
ClinicalTrials.gov Identifier: NCT00473707     History of Changes
Other Study ID Numbers: 26008
First Posted: May 15, 2007    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008

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

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