Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00257803
First received: November 21, 2005
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section. Both of these methods are commonly used. To date there has been little research to demonstrate that one method of giving oxytocin is better than another in women who are more likely to bleed after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes the uterus contract better to reduce bleeding and decreases the need to give additional oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their baby by cesarean section.


Condition Intervention
Postpartum Hemorrhage
Drug: Oxytocin
Drug: Saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double-blind Comparison of a 5 Unit Intravenous Oxytocin Bolus Versus Placebo as a Strategy to Prevent Uterine Atony at Cesarean Section in Women Who Are at Increased Risk of Post-Partum Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Need for additional oxytocics in women at high risk of hemorrhage [ Time Frame: within the first hour after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcomes include uterine tone and side effects. [ Time Frame: within 10 minutes of delivery and time from giving the bolus until placenta delivery ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: November 2005
Study Completion Date: December 2012
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.
Drug: Oxytocin
See detailed description
Placebo Comparator: 2
In one group, women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born.
Drug: Saline solution
See detailed description

Detailed Description:

Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section. Both of these methods are commonly used. To date there has been little research to demonstrate that one method of giving oxytocin is better than another in women who are more likely to bleed after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes the uterus contract better to reduce bleeding and decreases the need to give additional oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their baby by cesarean section.

Women who participate will be randomized (like a toss of a coin) to one of two groups. Neither the woman nor the anesthesiologist nor the obstetrician will know which group they are in.

In one group, the women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born. In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.

Both groups will have the standard amount of oxytocin given slowly (over a 30 minute period) into the intravenous in their arm (infusion). The amount of oxytocin that is put into the intravenous bag is a normal amount that would be given during cesarean section in any woman not involved in the study and it will be started after the initial injection has been given. The only difference between the two groups is that one group will have an extra dose of oxytocin given directly into the vein via the intravenous while the other will have a saline solution given directly into the vein via the intravenous.

Information that will be obtained during the study will include any decrease in blood pressure or increase in heart rate at the time the saline or oxytocin is given directly into the vein. The obstetrician will be asked to indicate how well the uterus is contracting and they can ask the anesthesiologist to give more oxytocin or a more powerful drug if, in their opinion, the uterus is not contracting well. This is the normal way that this is done.

If the woman should feel dizzy (possibly secondary to low blood pressure) their anesthesiologist will treat them the same way as they would if this happened to any woman who is not part of the study. In other words, the anesthesiologist and obstetrician will treat the woman the way they normally would whether the woman was part of the study or not.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 19 years or over
  • Having a cesarean section
  • Have one or more of the following

    1. a larger than average uterus, because of

      • a large baby
      • twins, triplets, etc
      • a large volume of fluid around the baby
    2. have received oxytocin to help stimulate labor for eight or more hours before cesarean section
    3. have infection inside the uterus that is treated with antibiotics
    4. bleeding after giving prior birth
    5. the placenta is in a position where it is more likely to bleed
    6. have had five or more pregnancies before current one

Exclusion Criteria:

  • Significant medical problem such that an oxytocin bolus might not be safe
  • Active bleeding and their blood pressure or pulse rate are not normal
  • Blood does not clot normally
  • Aged less than 19 years
  • Does not understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257803

Locations
Canada, British Columbia
BC Women's Hospital, Department of Anesthesia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Joanne Douglas, MD University of British Columbia
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00257803     History of Changes
Other Study ID Numbers: H05-70504, NHR05-0206
Study First Received: November 21, 2005
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Oxytocin, bolus, postpartum hemorrhage

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014