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A randomised preference trial of medical versus surgical termination of pregnancy less that 14 weeks' gestation - TOP study

A randomised preference trial of medical versus surgical termination of pregnancy less that 14 weeks' gestation - TOP study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002920-17-GB
Enrollment
2232
Registered
2005-04-05
Start date
2005-05-04
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

termination of pregnancy

Interventions

Trade Name: Cytotec Product Name: misoprostol Pharmaceutical Form: Tablet INN or Proposed INN: misoprostol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Tra

Sponsors

Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Women requesting and accepted for termination of pregnancy at less than 14 weeks gestation (as determined by ultrasound). Women under 16 years of age will be approached where they are determined to be Gillick competent (by the clinical practitioner) and where a parent/legal representative is present. Ability to give written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pre-existing medical disorder which is an indication for either medical or surgical termination of pregnancy. Non-English speaking women (apart from French, Mandarin, Cantonese, Bengali, Urdu or Arabic) due to limited availability of Interpreters. Previous participation in this trial. Current participation in a 'drug' related trial.

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the acceptibility of medical and surgical termination of pregnancy, as determined by the preferred method of any future termination ;Secondary Objective: To compare experiences of care, strength of preference, psychological impact, efficacy and cost effectiveness of surgical versus medical termination;Primary end point(s): The primary outcome variable is acceptibility of the method measured 2 weeks after the procedure; participants will be asked if they would have the same method of termination again.

Countries

United Kingdom

Outcome results

None listed

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