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Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107874
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 11, 2005
First Posted Date  ICMJE April 12, 2005
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE January 1999
Actual Primary Completion Date February 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Reduction of postpartum hemorrhage
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00107874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Blood loss
  • medicamentous side effects
  • efficacy of medicaments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE Drug: misoprostol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
56
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2002
Actual Primary Completion Date February 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107874
Other Study ID Numbers  ICMJE M73/99
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Irène Hösli, Prof. Dr. MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP