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ISRCTN
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ISRCTN10531821
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DOI
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10.1186/ISRCTN10531821
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Comparison of two routes and two intervals of administration of misoprostol for the termination of early pregnancy: a randomised multicentre trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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WHO/HRP ID A05217
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Study hypothesis
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To investigate the feasibility of the misoprostol-only regimen (0.8 mg vaginally or sublingually every 3 hours versus every 12 hours up to three doses).
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Lay summary
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Not provided at time of registration
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Ethics approval
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Institutional review boards at all participating hospitals and the World Health Organization (WHO) Secretariat Committee on Research on Human Subjects gave ethics approval.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Armenia, Cuba, Georgia, India, Mongolia, Viet Nam
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Disease/condition/study domain
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Induced abortion
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Participants - inclusion criteria
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1. Healthy women, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail
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Participants - exclusion criteria
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1. Any indication of serious past or present illness
2. Allergic to misoprostol or with a strong allergic tendency in general
3. Heavy smokers (greater than 20 cigarettes a day)
4. With a scar in the uterus or cervix or any gynaecological anomaly detected with ultrasound
5. A history or evidence of mitral stenosis, glaucoma, or sickle cell anaemia
6. Diastolic blood pressure greater than 90 mmHg
7. Uncontrolled bronchial asthma
8. Systolic blood pressure less than 90 mmHg
9. History or evidence of thromboembolism or liver disease
10. Presence of an intrauterine device in utero
11. Haemolytic disorders
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Anticipated start date
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01/12/2001
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Anticipated end date
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01/12/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2100
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Interventions
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Four treatment groups:
A: Sublingual misoprostol every 3 hours
B: Sublingual misoprostol every 12 hours
C: Vaginal misoprostol every 3 hours
D: Vaginal misoprostol every 12 hours
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Primary outcome measure(s)
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Effectiveness, induction to abortion interval, side effects and acceptability.
Approximate duration of involvement in the study for each subject: first follow-up at 15 days post-treatment, second follow-up (if required) at 42 days, subsequent follow-up as needed.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
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Trial website
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Publications
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1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17560446
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22432980
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Contact name
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Dr
Helena
von Hertzen
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Email
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vonhertzenh@who.int
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Sponsor
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UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int/reproductive-health/hrp/
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Date applied
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19/03/2004
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Last edited
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30/07/2012
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Date ISRCTN assigned
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01/04/2004
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