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Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-Scheduled Cesarean Section
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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 |
- Reduction of postpartum hemorrhage
- Blood loss
- medicamentous side effects
- efficacy of medicaments
| Estimated Enrollment: | 56 |
| Study Start Date: | January 1999 |
| Estimated Study Completion Date: | February 2002 |
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) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00107874
| Switzerland | |
| Women’s University Hospital, Basel | |
| Basel, Switzerland, 4031 | |
| 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 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017