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 of protocol

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 design	Multicentre randomized double-blinded placebo-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Misoprostol in the management of retained placenta - a safe alternative for manual removal? A randomised controlled trial
Study objectives	The 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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure	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 study start date	01/08/2007
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	100
Total final enrolment	99
Key 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
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	01/08/2009

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

Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/english/start_english.html#http:// http://www.lumc.nl/english/start_english.html
"ROR"	https://ror.org/027bh9e22

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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.