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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00107874

First Posted: April 12, 2005

Last Update Posted: December 9, 2005

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.

Information provided by:

Basel Women’s University Hospital

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 Intervention Model: Parallel Assignment Masking: Double 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:

MedlinePlus related topics: Bleeding Cesarean Section Postpartum Care

Drug Information available for: Oxytocin Misoprostol

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	April 11, 2005
First Posted:	April 12, 2005
Last Update Posted:	December 9, 2005
Last Verified:	April 2005

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 Oxytocin	Misoprostol Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents

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