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 |
| Protocol serial number | N/A |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (The Netherlands) |
- 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
Scientific
Leiden University Medical Centre (LUMC)
Department of Gynaecology
Leiden
2300 RC
Netherlands
| G.van_Stralen@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomized double-blinded placebo-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure(s) |
1. Number of spontaneous delivered placentas |
| Key secondary outcome measure(s) |
1. Interval between delivery of the baby and administration of misoprostol |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
