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


- candidate number2636
- NTR NumberNTR1002
- ISRCTNISRCTN45330307
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR25-jun-2007
- Secondary IDs 
- Public TitleMisoprostol in the management of retained placenta, a safe alternative for manual removal? A randomised controlled trial.
- Scientific TitleMisoprostol in the management of retained placenta, a safe alternative for manual removal? A randomised controlled trial.
- ACRONYM
- hypothesisThe use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
- Healt Condition(s) or Problem(s) studiedRetained placenta
- Inclusion criteria1. All women with at least 25 completed pregnancy weeks and retained placenta; 2. At least 18 years of age; 3. Master the Dutch language in word and script.
- Exclusion criteria1. Excessive blood loss (>1000 ml) within 60 minutes after the delivery of the newborn; 2. Allergy for misoprostol or one of its components.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate1-aug-2009
- Target number of participants100
- InterventionsIn case of retained placenta: administration of either 800 mcg of misoprostol or placebo 60 minutes after birth of the baby, in absence of postpartum haemorrhage
- Primary outcome1. Number of spontaneous delivered placentas; 2. Number of manual removals and amount of blood loss.
- Secondary outcome1. Interval between delivery of the baby and administration of misoprostol; 2. Interval between administration of misoprostol and delivery of the placenta; 3. Placenta captiva.
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Giel Stralen, van
- CONTACT for SCIENTIFIC QUERIES Giel Stralen, van
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Gynaecology
- Publications
- Brief summaryObjective 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? Method All women with retained placenta after vaginal birth will be included in our study. Misoprostol 800 mcg or placebo will be administered. If a final attempt to deliver the placenta by controlled cord traction after 45 minutes fails, manual removal of the placenta will be performed. Side effects will be registered. Sample size Considering the results of our pilotstudy and historical data we want to include 100 women. Outcome 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.
- Main changes (audit trail)
- RECORD25-jun-2007 - 27-aug-2007


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