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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
ISRCTN ISRCTN10531821
DOI 10.1186/ISRCTN10531821
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of two routes and two intervals of administration of misoprostol for the termination of early pregnancy: a randomised multicentre trial
Scientific title
Acronym N/A
Serial number at source WHO/HRP ID A05217
Study hypothesis 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).
Lay summary Not provided at time of registration
Ethics approval Institutional review boards at all participating hospitals and the World Health Organization (WHO) Secretariat Committee on Research on Human Subjects gave ethics approval.
Study design Randomised controlled trial
Countries of recruitment Armenia, Cuba, Georgia, India, Mongolia, Viet Nam
Disease/condition/study domain Induced abortion
Participants - inclusion criteria 1. Healthy women, eligible for and requesting medical abortion
2. Agrees to surgical termination should method fail
Participants - exclusion criteria 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
Anticipated start date 01/12/2001
Anticipated end date 01/12/2002
Status of trial Completed
Patient information material
Target number of participants 2100
Interventions 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
Primary outcome measure(s) 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.
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 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17560446
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22432980
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 19/03/2004
Last edited 30/07/2012
Date ISRCTN assigned 01/04/2004
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