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?

NCT00257803 | Completed

• 2 other identifiers: H05-70504NHR05-0206
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

Oxytocin, bolus, postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• Need for additional oxytocics in women at high risk of hemorrhage

  within the first hour after delivery

Secondary Outcomes (1)

• Secondary outcomes include uterine tone and side effects.

  within 10 minutes of delivery and time from giving the bolus until placenta delivery

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Oxytocin DRUG

See detailed description

1

Saline solution DRUG

See detailed description

2

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 years or over
• Having a cesarean section
• Have one or more of the following
• a larger than average uterus, because of
• a large baby
• twins, triplets, etc
• a large volume of fluid around the baby
• have received oxytocin to help stimulate labor for eight or more hours before cesarean section
• have infection inside the uterus that is treated with antibiotics
• bleeding after giving prior birth
• the placenta is in a position where it is more likely to bleed
• have had five or more pregnancies before current one

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital, Department of Anesthesia

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• King KJ, Douglas MJ, Unger W, Wong A, King RA. Five unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesth Analg. 2010 Dec;111(6):1460-6. doi: 10.1213/ANE.0b013e3181f8930a. Epub 2010 Oct 1.

  PMID: 20889945 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Joanne Douglas, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: December 1, 2012
• Last Updated: March 17, 2014

Record last verified: 2014-02

Locations

CA (1)