Comparing efficacy of vaginal misoprostol administered at 6-8 hours with 24 hours administration after 200 mg of oral mifepristone for early medical abortions

Not Applicable

Completed

Conditions: Early medical abortion
Pregnancy and Childbirth
Medical abortion

Registration Number: ISRCTN97410750

Lead Sponsor: Calthorpe Clinic (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1200

Inclusion Criteria

1. Ability to give informed written consent
2. Women who are 18 years and older
3. Requesting abortion and eligible for legal termination of pregnancy
4. Duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle or verified by ultrasound
5. The pregnancy is single and intrauterine (single sac)
6. Agree to be able to be contacted by telephone (i.e. mobile telephone)
7. Women with limited understanding of English will be included only in the quantitative study where interpreters are available

Exclusion Criteria

1. Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study
2. Suspicion of any pathology of pregnancy (e.g. molar, non-viable pregnancy, threatened abortion)
3. Current participation in a drug-related trial
4. Non-English-speaking women for the qualitative study
5. Women under the age of 18 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of complete abortions where no further medical or surgical intervention beyond the initial dose of vaginal misoprostol required was measured using patient acceptability questionnaire and ultrasound confirmation at the end of 2 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Induction to abortion interval is measured using based on the duration of pain and bleeding at 2 weeks follow up<br>2. Adverse effects is measured using Likert scale at 2 weeks follow up<br>3. Pain is measured using VAS at 2 weeks follow up<br>4. Duration of Bleeding is measured using the No.of hours or days at 2 weeks follow up<br>5. Acceptability of women towards the new regimen is measured using Likert scale at the 2 weeks follow up<br>6. Assess reliability of follow-up methods following medical abortion is measured using telephone follow up at 1 week and Urinary quantification of hCG at baseline.2 weeks<br><br>For the purpose of qualitative study face to face in depth interviews were conducted at the end of 2 weeks