Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
misoprostol
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Maternal, morbidity, mortality, pregnancy, postpartum hemorrhage, Cesarean Section
Eligibility Criteria
Inclusion Criteria: Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation Exclusion Criteria: Emergency CS Fetal distress Fetal malformations Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome) Hypersensitivity to prostaglandins Coagulopathy Severe systemic disorders An American Society of Anesthesiologists (ASA) physical status >/= 3 Severe asthma Prior myomectomy Maternal fever (> 38.5 °C)
Sites / Locations
- Women's University Hospital, Basel
Outcomes
Primary Outcome Measures
Reduction of postpartum hemorrhage
Secondary Outcome Measures
Blood loss
medicamentous side effects
efficacy of medicaments
Full Information
NCT ID
NCT00107874
First Posted
April 11, 2005
Last Updated
April 2, 2019
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00107874
Brief Title
Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
Official Title
Oral Misoprostol as a Second-line Alternative to Intravenous Oxytocin in Preventing Postoperative Blood Loss After Non-scheduled Cesarean Section: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries.
With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section.
We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
Detailed Description
Postpartum hemorrhage (PPH) is still among the leading causes of maternal morbidity and mortality. The incidence of PPH is reduced by active management of the third stage of labor which includes the use of uterotonics for pharmacological prophylaxis. However, there is an on-going debate about the optimal drug selection since uterotonics such as oxytocin and methylergometrine are liable for specific side effects and complications when administered within a dose range needed to be effective for PPH. In the search for an alternative to these conventional standard uterotonics, misoprostol (prostaglandin E1) has turned out to be an effective therapeutic option and has been implemented in actual treatment regimens. The objective of this study was to compare the effectiveness of oral applicated misoprostol versus intravenous oxytocin in reducing blood loss in low risk obstetric patients undergoing non-scheduled cesarean section (CS) under spinal anesthesia.
Comparison:
In this prospective, double blind study, parturients undergoing CS were randomized to receive either a) oral misoprostol and an infusion of normal saline supplemented with placebo, or b) an oral placebo and an infusion of normal saline, supplemented with oxytocin subsequently to intravenous oxytocin after cord clamping in both groups.
The primary outcomes were the amount of intra- and postoperative blood loss and the occurrence of drug-related side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Maternal, morbidity, mortality, pregnancy, postpartum hemorrhage, Cesarean Section
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
misoprostol
Primary Outcome Measure Information:
Title
Reduction of postpartum hemorrhage
Secondary Outcome Measure Information:
Title
Blood loss
Title
medicamentous side effects
Title
efficacy of medicaments
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation
Exclusion Criteria:
Emergency CS
Fetal distress
Fetal malformations
Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome)
Hypersensitivity to prostaglandins
Coagulopathy
Severe systemic disorders
An American Society of Anesthesiologists (ASA) physical status >/= 3
Severe asthma
Prior myomectomy
Maternal fever (> 38.5 °C)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irène Hösli, Prof. Dr. MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Women's University Hospital, Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
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