Condition category
Pregnancy and Childbirth
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
28/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes