Medical treatment of retained placenta: does it reduce the number of necessary surgical interventions? A randomised controlled trial in low resource setting
| ISRCTN | ISRCTN16104753 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16104753 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/04/2008
- Registration date
- 21/04/2008
- Last edited
- 10/03/2014
- 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 Heleen van Beekhuizen
Scientific
Scientific
P.O. Box 228
Lindi
-
Tanzania
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (available in Kiswahili and English) |
| Scientific title | Treatment of a retained placenta with misoprostol, a double-blind randomised controlled trial in Tanzania |
| Study hypothesis | Misoprostol will reduce the amount of manual removals of the placenta. |
| Ethics approval(s) | Ethics approval received from the National Institute for Medical Research Tanzania on the 27th November 2007 (ref: NIMR/HQ/R.8a/Vol IX/645). |
| Condition | Retained placenta |
| Intervention | Study medication will be randomised in blocks and the allocation of sealed envelopes will be in sequence of enrolment. Randomisation of misoprostol to placebo will be 2:1. 30 minutes after delivery of the baby the women will receive study medication sublingually: either misoprostol 800 microgram or placebo. Duration of follow up: until discharge next day if no complications occur. At discharge patient will be counselled that they have to come back in case of complications (blood loss and/or fever). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol |
| Primary outcome measure | Reduction in the amount of manual removal of placenta (under anaesthesia) 60 minutes after delivery of the baby. |
| Secondary outcome measures | 1. Blood loss 2. Need for blood transfusion Hb will be checked the morning after the manual removal or the sponteneous expulsion of the placenta. After this it will be decided if a blood transfusion is necessary. |
| Overall study start date | 04/04/2008 |
| Overall study end date | 04/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 117 (39 patients will receive placebo and 78 will receive misoprostol) |
| Participant inclusion criteria | Women with a retained placenta 30 minutes after delivery of the newborn (and a pregnancy duration of at least 28 weeks [birth weight 1 kg]). All women will receive active management of third stage of labour before inclusion. |
| Participant exclusion criteria | 1. Blood loss greater than 750 ml 30 minutes after delivery 2. Pulse rate greater than 120 beats/minute 3. Blood pressure (BP) dropped greater than 20 mmHg diastolic compared with BP before delivery 4. Anaemia (haemoglobin [Hb] less than 100 g/dl). Measurement of third trimester of pregnancy or around delivery |
| Recruitment start date | 04/04/2008 |
| Recruitment end date | 04/04/2010 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
P.O. Box 228
Lindi
-
Tanzania
-
Tanzania
Sponsor information
Tanzanian German Programme to Support Health (TGPSH) (Tanzania)
Research organisation
Research organisation
P.O. Box 65350
Dar es Salaam
-
Tanzania
| Website | http://www.tgpsh.or.tz |
|---|
Funders
Funder type
Research organisation
Tanzanian German Programme to Support Health (TGPSH) (Tanzania) - allows personnel to conduct this study during working hours and will provide transportation, administration and logistics
No information available
Radboud University Medical Center (Netherlands) - study medication provided free of charge
No information available
The researcher will perform the job unpaid, as will the staff in the joining health facilities.
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/10/2009 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No |
