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A double-blind, randomised, controlled multicentre trial of three misoprostol regimens after pretreatment with mifepristone for termination of early pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81170837
Enrollment
2100
Registered
2004-04-01
Start date
1998-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Induced abortion Pregnancy and Childbirth Abortion

Interventions

All women treated with a single dose of 200 mg mifepristone on Day 1. Day 3: Group A: 0.8 mg misoprostol orally and placebo tablets vaginally. Groups B and C: 0.8 mg misoprostol vaginally and placeb

Sponsors

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women 2. Eligible for and requesting medical abortion 3. Prepared to terminate the pregnancy should the treatment fail

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

MeasureTime frame
Three treatment regimens will be compared in terms of: 1. Their effectiveness to induce complete abortion 2. The frequency of side effects 3. The duration of bleeding Approximate duration of involvement in the study for each subject: second follow-up visit on day 43 post treatment, third follow-up visit if required

Secondary

MeasureTime frame
No secondary outcome measures

Countries

China, Finland, Hong Kong, Hungary, India, Mongolia, Norway, Romania, Singapore, Slovenia, Sweden, Viet Nam

Outcome results

None listed

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