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Misoprostol in the management of retained placenta - a safe alternative for manual removal? A randomised controlled trial
ISRCTN ISRCTN45330307
DOI 10.1186/ISRCTN45330307
ClinicalTrials.gov identifier
EudraCT number
Public title Misoprostol in the management of retained placenta - a safe alternative for manual removal? A randomised controlled trial
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis The use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee (Commissie Medische Ethiek) on the 17th August 2007 (ref: P07-011).
Study design Multicentre, randomised, double-blinded, placebo controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Retained placenta
Participants - inclusion criteria 1. 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
Participants - exclusion criteria 1. Excessive blood loss (greater than 1000 ml) within 60 minutes after the delivery of the newborn
2. Allergy for misoprostol or one of its components
Anticipated start date 01/08/2007
Anticipated end date 01/08/2009
Status of trial Completed
Patient information material
Target number of participants 100
Interventions All women with retained placenta after vaginal birth will be included in our study. In the case of a retained placenta, administration of either 800 mcg of misoprostol or placebo 60 minutes after birth of the baby will be performed, in absence of postpartum haemorrhage. 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.
Primary outcome measure(s) 1. Number of spontaneous delivered placentas
2. Number of manual removals and amount of blood loss
Secondary outcome measure(s) 1. Interval between delivery of the baby and administration of misoprostol
2. Interval between administration of misoprostol and delivery of the placenta
3. Placenta captiva
Sources of funding Leiden University Medical Centre (LUMC) (The Netherlands)
Trial website
Publications
Contact name Dr  Giel   van Stralen
  Address Leiden University Medical Centre (LUMC)
Department of Gynaecology
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
  Email G.van_Stralen@lumc.nl
Sponsor Leiden University Medical Centre (LUMC) (The Netherlands)
  Address Department of Gynaecology
P.O. Box 9600
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
  Sponsor website: http://www.lumc.nl/english/start_english.html#http:// http://www.lumc.nl/english/start_english.html
Date applied 23/08/2007
Last edited 28/08/2007
Date ISRCTN assigned 23/08/2007
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