Condition category
Pregnancy and Childbirth
Date applied
02/04/2008
Date assigned
21/04/2008
Last edited
10/03/2014
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 Heleen van Beekhuizen

ORCID ID

Contact details

P.O. Box 228
Lindi
-
Tanzania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of a retained placenta with misoprostol, a double-blind randomised controlled trial in Tanzania

Acronym

Study hypothesis

Misoprostol will reduce the amount of manual removals of the placenta.

Ethics approval

Ethics approval received from the National Institute for Medical Research Tanzania on the 27th November 2007 (ref: NIMR/HQ/R.8a/Vol IX/645).

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (available in Kiswahili and English)

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

Phase

Not Specified

Drug names

Misoprostol

Primary outcome measures

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 trial start date

04/04/2008

Overall trial end date

04/04/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

117 (39 patients will receive placebo and 78 will receive misoprostol)

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

Trial participating centre

P.O. Box 228
Lindi
-
Tanzania

Sponsor information

Organisation

Tanzanian German Programme to Support Health (TGPSH) (Tanzania)

Sponsor details

P.O. Box 65350
Dar es Salaam
-
Tanzania

Sponsor type

Research organisation

Website

http://www.tgpsh.or.tz

Funders

Funder type

Research organisation

Funder name

Tanzanian German Programme to Support Health (TGPSH) (Tanzania) - allows personnel to conduct this study during working hours and will provide transportation, administration and logistics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Radboud University Medical Center (Netherlands) - study medication provided free of charge

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The researcher will perform the job unpaid, as will the staff in the joining health facilities.

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19852814
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23791153

Publication citations

  1. Protocol

    van Beekhuizen HJ, Pembe AB, Fauteck H, Lotgering FK, Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania)., BMC Pregnancy Childbirth, 2009, 9, 48, doi: 10.1186/1471-2393-9-48.

  2. Results

    van Beekhuizen HJ, Tarimo V, Pembe AB, Fauteck H, Lotgering FK, A randomized controlled trial on the value of misoprostol for the treatment of retained placenta in a low-resource setting., Int J Gynaecol Obstet, 2013, 122, 3, 234-237, doi: 10.1016/j.ijgo.2013.03.029.

Additional files

Editorial Notes