Contact information
Type
Scientific
Primary contact
Dr Giel van Stralen
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Department of Gynaecology
Leiden
2300 RC
Netherlands
G.van_Stralen@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Retained placenta
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Misoprostol
Primary outcome measures
1. Number of spontaneous delivered placentas
2. Number of manual removals and amount of blood loss
Secondary outcome measures
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
Overall trial start date
01/08/2007
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant 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
Recruitment start date
01/08/2007
Recruitment end date
01/08/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (The Netherlands)
Sponsor details
Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.lumc.nl/english/start_english.html#http:// http://www.lumc.nl/english/start_english.html
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary