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

ISRCTN ISRCTN45330307
DOI https://doi.org/10.1186/ISRCTN45330307
Secondary identifying numbers N/A
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
07/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Giel van Stralen
Scientific

Leiden University Medical Centre (LUMC)
Department of Gynaecology
Leiden
2300 RC
Netherlands

Email G.van_Stralen@lumc.nl

Study information

Study designMulticentre randomized double-blinded placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleMisoprostol in the management of retained placenta - a safe alternative for manual removal? A randomised controlled trial
Study hypothesisThe use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
Ethics approval(s)Approved 17/08/2007, local medical ethics committee (Commissie Medische Ethiek), ref: P07-011
ConditionRetained placenta
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Misoprostol
Primary outcome measure1. Number of spontaneous delivered placentas
2. Number of manual removals and amount of blood loss
Secondary outcome measures1. 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 study start date01/08/2007
Overall study end date01/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants100
Total final enrolment99
Participant 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
Participant exclusion criteria1. 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 date01/08/2007
Recruitment end date01/08/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre

Funders

Funder type

Hospital/treatment centre

Leiden University Medical Centre (LUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 21/01/2013 07/10/2021 Yes No

Editorial Notes

07/10/2021: Publication reference and total final enrolment added.