Misoprostol in the management of retained placenta, a safe alternative for manual removal? A randomised controlled trial. - Misoprostol in the management of retained placenta, a safe alternative for manual removal? A random

Active, not recruiting

Conditions: To assess the effectiveness of misoprostol in the management of retained placenta. Will 800 micrograms of misoprostol orally reduce the need for manual removal under general anaesthesia and prove to be a safe alternative?
MedDRA version: 8.1Level: HLTClassification code 10017847Term: Gastric ulcers and perforation

Registration Number: EUCTR2006-006371-20-NL

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 100

Inclusion Criteria

All women with at least 25 completed pregnancy weeks and retained placenta.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excessive blood loss (>1000 ml) within 60 minutes after the delivery of the newborn. Allergy for misoprostol or one of its components.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness of misoprostol in the management of retained placenta. Will 800 micrograms of misoprostol orally reduce the need for manual removal under general anaesthesia and prove to be a safe alternative?;Secondary Objective: Side effects of misoprostol;Primary end point(s): Primary: number of spontaneous delivered placentas, number of manual removals and amount of blood loss. Secondary: interval between delivery of the baby and administration of misoprostol, interval between administration of misoprostol and delivery of the placenta, placenta captiva.<br>Possible side effects: diarrhoea, abdominal pain, nausea, dyspepsia, vomiting, headache and dizziness within two hours after administration of misoprostol or placebo.<br>

Secondary Outcome Measures