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ISRCTN
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ISRCTN16104753
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ClinicalTrials.gov identifier
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Public title
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Medical treatment of retained placenta: does it reduce the number of necessary surgical intreventions? A randomised controlled trial in low resource setting
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Scientific title
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Treatment of a retained placenta with misoprostol, a double-blind randomised controlled trial in Tanzania
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Misoprostol will reduce the amount of manual removals of the placenta.
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Ethics approval
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Ethics approval received from the National Institute for Medical Research Tanzania on the 27th November 2007 (ref: NIMR/HQ/R.8a/Vol IX/645).
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Study design
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Double-blind randomised controlled trial
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Countries of recruitment
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Tanzania
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Disease/condition/study domain
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Retained placenta
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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04/04/2008
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Anticipated end date
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04/04/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet (available in Kiswahili and English)
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Target number of participants
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117 (39 patients will receive placebo and 78 will receive misoprostol)
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Interventions
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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).
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Primary outcome measure(s)
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Reduction in the amount of manual removal of placenta (under anaesthesia) 60 minutes after delivery of the baby.
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. Tanzanian German Programme to Support Health (TGPSH) (Tanzania) - allows personnel to conduct this study during working hours and will provide transportation, administration and logistics
2. Radboud University Medical Center (The Netherlands) - study medication provided free of charge
The researcher will perform the job unpaid, as will the staff in the joining health facilities.
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Trial website
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Publications
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Contact name
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Dr
Heleen
van Beekhuizen
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Address
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P.O. Box 228
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City/town
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Lindi
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Zip/Postcode
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-
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Country
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Tanzania
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Sponsor
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Tanzanian German Programme to Support Health (TGPSH) (Tanzania)
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Address
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P.O. Box 65350
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City/town
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Dar es Salaam
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Zip/Postcode
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-
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Country
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Tanzania
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Sponsor website:
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http://www.tgpsh.or.tz
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Date applied
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02/04/2008
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Last edited
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21/04/2008
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Date ISRCTN assigned
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21/04/2008
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