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ISRCTN
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ISRCTN72965671
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ClinicalTrials.gov identifier
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Public title
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Misoprostol administered sublingually for second trimester pregnancy termination
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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 A15065
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Study hypothesis
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To compare two treatment regimens (0.4 mg misoprostol administered sublingually versus vaginally every three hours up to five doses) for the termination of pregnancy in women with a length of amenorrhoea between 14 to 20 weeks.
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Ethics approval
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Not provided at time of registration
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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, Georgia, Hungary, India, Slovenia, South Africa, Viet Nam, Zambia
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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
2. Eligible for and requesting legal termination of second trimester pregnancy
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Participants - exclusion criteria
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No exclusion criteria
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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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680
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Interventions
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Misoprostol (0.4 mg) either vaginally or sublingually every three hours up to five doses.
Approximate duration of involvement in the study for each subject: first follow up at 15 days post-treatment, another follow-up visit will be carried out according to the practice of the hospital.
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Primary outcome measure(s)
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1. The effectiveness to induce complete or partial abortion/induction-to-abortion interval
2. The frequency of side effects
3. Acceptability of treatment to women
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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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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15327617
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18794161
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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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11/12/2008
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Date ISRCTN assigned
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01/04/2004
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