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

This study has been completed.
Sponsor:
Information provided by:
Basel Women’s University Hospital
ClinicalTrials.gov Identifier:
NCT00107874
First received: April 11, 2005
Last updated: June 23, 2005
Last verified: April 2005

April 11, 2005
June 23, 2005
January 1999
Not Provided
Reduction of postpartum hemorrhage
Same as current
Complete list of historical versions of study NCT00107874 on ClinicalTrials.gov Archive Site
  • Blood loss
  • medicamentous side effects
  • efficacy of medicaments
Same as current
Not Provided
Not Provided
 
Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-Scheduled Cesarean Section
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Postpartum Hemorrhage
Drug: misoprostol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2002
Not Provided

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00107874
M73/99
Not Provided
Not Provided
Basel Women’s University Hospital
Not Provided
Study Chair: Irène Hösli Women’s University Hospital, Basel, Switzerland
Basel Women’s University Hospital
April 2005

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