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A double-blind, randomised, controlled multicentre trial of misoprostol treatment prior to Vacuum Aspiration for termination of early pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98284169
Enrollment
4984
Registered
2007-05-03
Start date
2002-10-21
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

Termination of early pregnancy by vacuum aspiration Pregnancy and Childbirth Termination

Interventions

Two tablets of 200 micrograms of misoprostol or two placebo tablets will be administered vaginally three hours before vacuum aspiration. Type of analgesia/anaesthesia, baseline cervical dilation, dura

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. Women requesting abortion and eligible for legal termination of normal single intrauterine pregnancy of less than 12 completed weeks (84 days) of gestation 2. Consent to participation 3. Able to understand information on the study 4. Agree to return for the scheduled follow-up visit

Exclusion criteria

Exclusion criteria: Women are not eligible if they have: 1. A medical condition or disease that requires special treatment, care of precautions in conjunction with vacuum aspiration 2. Allergy to misoprostol 3. Contraindications to misoprostol 4. Anaemia or any coagulation disorder

Design outcomes

Primary

MeasureTime frame
Complication rates in misoprostol and placebo groups, measured during the procedure, in the immediate post-operative period, and up until the follow-up visit 7 to 14 days after the procedure

Secondary

MeasureTime frame
1. Ease of the procedure (dilation, duration of procedure, pain level), measured during the procedure 2. Side-effects, measured at any time after administration of misoprostol until the end of the study

Countries

Armenia, China, Cuba, Hungary, India, Mongolia, Romania, Slovenia, Viet Nam

Outcome results

None listed

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