Misoprostol in the management of retained placenta - a safe alternative for manual removal? A randomised controlled trial
ISRCTN | ISRCTN45330307 |
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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
Scientific
Leiden University Medical Centre (LUMC)
Department of Gynaecology
Leiden
2300 RC
Netherlands
G.van_Stralen@lumc.nl |
Study information
Study design | Multicentre randomized double-blinded placebo-controlled parallel-group trial |
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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 hypothesis | 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 |
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 |
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 |
Overall study end date | 01/08/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 100 |
Total final enrolment | 99 |
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 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
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
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 |
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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 | |
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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? |
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Results article | 21/01/2013 | 07/10/2021 | Yes | No |
Editorial Notes
07/10/2021: Publication reference and total final enrolment added.