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: 8.1 Level: HLT Classification code 10017847 Term: Gastric ulcers and perforation
Conditions
Interventions
Trade Name: Cytotec
Product Name: cytotec
Product Code: A02BB01
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: MISOPROSTOL
CAS Number: 59122462
Concentration unit: µg microgram(s)
Concentra
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Excessive blood loss (>1000 ml) within 60 minutes after the delivery of the newborn. Allergy for misoprostol or one of its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Possible side effects: diarrhoea, abdominal pain, nausea, dyspepsia, vomiting, headache and dizziness within two hours after administration of misoprostol or placebo. | — |
Countries
Netherlands
Outcome results
None listed