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ISRCTN
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ISRCTN85366519
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ClinicalTrials.gov identifier
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Public title
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Pretreatment with vaginal misoprostol before vacuum aspiration
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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 A15066
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Study hypothesis
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To evaluate if vaginal administration of 0.4 mg misoprostol facilitates cervical dilation, reduces complications of first trimester induced abortion, and is acceptable to women.
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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, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia, 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. Pregnancy of less than 12 completed weeks
2. Be informed about the study and sign a consent form
3. Agree to return for a follow-up visit five to ten days after surgery
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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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4464
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Interventions
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Misoprostol (0.4 mg) versus placebo tablet three hours before vacuum aspiration. Approximate duration of involvement in the study for each subject is one follow up visit ten days post-treatment.
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Primary outcome measure(s)
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Will evaluate if preoperative treatment with 0.4 mg misoprostol administered vaginally three hours before vacuum aspiration can reduce complications of surgical first trimester abortion.
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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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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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22/03/2004
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Last edited
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09/11/2007
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Date ISRCTN assigned
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01/04/2004
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