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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10531821
Enrollment
2100
Registered
2004-04-01
Start date
2001-12-01
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

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

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women, eligible for and requesting medical abortion 2. Agrees to surgical termination should method fail

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Armenia, Cuba, Georgia, India, Mongolia, Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026