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Pretreatment with vaginal misoprostol before vacuum aspiration
ISRCTN ISRCTN85366519
DOI 10.1186/ISRCTN85366519
ClinicalTrials.gov identifier
EudraCT number
Public title Pretreatment with vaginal misoprostol before vacuum aspiration
Scientific title
Acronym N/A
Serial number at source WHO/HRP ID A15066
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Armenia, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia, Viet Nam
Disease/condition/study domain Induced abortion
Participants - inclusion criteria 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
Participants - exclusion criteria No exclusion criteria
Anticipated start date 01/12/2001
Anticipated end date 01/12/2002
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 4464
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 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)
Trial website
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22405255
Contact name Dr  Helena  von Hertzen
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Email vonhertzenh@who.int
Sponsor UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Sponsor website: http://www.who.int/reproductive-health/hrp/
Date applied 22/03/2004
Last edited 10/10/2014
Date ISRCTN assigned 01/04/2004
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