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

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107874
• Other study ID #: M73/99
• Status: Completed
• Phase: Phase 2
• Start date: January 1999
• Est. completion date: February 2002

Study information

• Verified date: April 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• misoprostol

Locations

Country	Name	City	State
Switzerland	Women's University Hospital, Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of postpartum hemorrhage
Secondary	Blood loss
Secondary	medicamentous side effects
Secondary	efficacy of medicaments