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
Protocol serial number	N/A
Sponsor	Tanzanian German Programme to Support Health (TGPSH) (Tanzania)
Funders	Tanzanian German Programme to Support Health (TGPSH) (Tanzania) - allows personnel to conduct this study during working hours and will provide transportation, administration and logistics, Radboud University Medical Center (Netherlands) - study medication provided free of charge, The researcher will perform the job unpaid, as will the staff in the joining health facilities.

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 of protocol

Not provided at time of registration

Contact information

Dr Heleen van Beekhuizen
Scientific

P.O. Box 228
Lindi
-
Tanzania

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Treatment of a retained placenta with misoprostol, a double-blind randomised controlled trial in Tanzania
Study objectives	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).
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	Reduction in the amount of manual removal of placenta (under anaesthesia) 60 minutes after delivery of the baby.
Key secondary outcome measure(s)	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.
Completion date	04/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	117
Key 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.
Key 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
Date of first enrolment	04/04/2008
Date of final enrolment	04/04/2010

Locations

Countries of recruitment

Tanzania

Study participating centre

P.O. Box 228

Lindi
-
Tanzania

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	results	01/09/2013		Yes	No
Protocol article	protocol	23/10/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes