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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Postpartum Hemorrhage
 Drug: misoprostol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Basel Women’s University Hospital:

Primary Outcome Measures:
  • Reduction of postpartum hemorrhage

Secondary Outcome Measures:
  • Blood loss
  • medicamentous side effects
  • efficacy of medicaments
Estimated Enrollment: 56
Study Start Date: January 1999
Estimated Study Completion Date: February 2002
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107874

Locations
Switzerland
Women’s University Hospital, Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Basel Women’s University Hospital
Investigators
Study Chair: Irène Hösli Women’s University Hospital, Basel, Switzerland
  More Information

ClinicalTrials.gov Identifier: NCT00107874     History of Changes
Other Study ID Numbers: M73/99 
Study First Received: April 11, 2005
Last Updated: June 23, 2005
Health Authority: Switzerland: Swissmedic

Keywords provided by Basel Women’s University Hospital:
Maternal
morbidity
mortality
 pregnancy
postpartum hemorrhage
Cesarean Section

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
 Oxytocin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 30, 2016