Clinical trial NCT00107874: Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Keywords: Maternal
morbidity
mortality
pregnancy
postpartum hemorrhage
Cesarean Section
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2005-04-12
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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)

Primary outcomes:
measure: Reduction of postpartum hemorrhage
Secondary outcomes:
measure: Blood loss
measure: medicamentous side effects
measure: efficacy of medicaments
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Women's University Hospital, Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Irène Hösli, Prof. Dr. MD
role: STUDY_CHAIR
References: