Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-Scheduled Cesarean Section
|ClinicalTrials.gov Identifier: NCT00107874|
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||April 11, 2005|
|First Posted Date ICMJE||April 12, 2005|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||January 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Reduction of postpartum hemorrhage|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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|
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.
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||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Condition ICMJE||Postpartum Hemorrhage|
|Intervention ICMJE||Drug: misoprostol|
|Study Arms||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 Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||February 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Switzerland|
|Removed Location Countries|
|NCT Number ICMJE||NCT00107874|
|Other Study ID Numbers ICMJE||M73/99|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Basel Women’s University Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||Basel Women’s University Hospital|
|Verification Date||April 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP