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

A randomised controlled trial on Efficacy of mifepristone followed by 6-8 hours versus 24 hours vaginal misoprostol in Early Medical Abortions (< 63 days gestation)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97410750

Enrollment

1200

Registered

2009-03-06

Start date

2009-09-15

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early medical abortion Pregnancy and Childbirth Medical abortion

Interventions

Participants are randomised to one of two groups using computerised randomisation Control group: Participants receive the standard treatment regimen of 800mcg of misoprostol as vaginal route 24 hours

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Induction to abortion interval is measured using based on the duration of pain and bleeding at 2 weeks follow up 2. Adverse effects is measured using Likert scale at 2 weeks follow up 3. Pain is measured using VAS at 2 weeks follow up 4. Duration of Bleeding is measured using the No.of hours or days at 2 weeks follow up 5. Acceptability of women towards the new regimen is measured using Likert scale at the 2 weeks follow up 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 For the purpose of qualitative study face to face in depth interviews were conducted at the end of 2 weeks	—

Measure

Time frame

1. Induction to abortion interval is measured using based on the duration of pain and bleeding at 2 weeks follow up 2. Adverse effects is measured using Likert scale at 2 weeks follow up 3. Pain is measured using VAS at 2 weeks follow up 4. Duration of Bleeding is measured using the No.of hours or days at 2 weeks follow up 5. Acceptability of women towards the new regimen is measured using Likert scale at the 2 weeks follow up 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 For the purpose of qualitative study face to face in depth interviews were conducted at the end of 2 weeks

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026