Medical versus surgical termination of pregnancy at 13 - 20 weeks
Completed
- Conditions
- Termination of unwanted pregnancyPregnancy and ChildbirthMedical abortion
- Registration Number
- ISRCTN17262711
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
1. Women accepted for termination of pregnancy (TOP) under clause C of the Human Fertilisation and Embryology Act (1990) amendment of the Abortion Act (1967)
2. Pregnancies between 13+0 and 19+6 weeks' gestation at the time of abortion
3. Aged over 16 years; women under 16 years of age were eligible for inclusion if deemed Fraser competent by the clinical practitioner and where a parent or guardian was present and also willing to give written consent
Exclusion Criteria
1. Foetal congenital abnormality
2. Medical disease precluding MTOP
3. Unable to speak English (less than 5% of women presenting for TOP)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of Event Scale (IES) at two weeks after the procedure. This 15 item scale has 7 intrusion and 8 avoidance items.
- Secondary Outcome Measures
Name Time Method 1. Clinical effectiveness of procedure, measured at two weeks post-procedure<br>2. Complications, measured at two weeks post-procedure<br>3. Procedure specific symptoms, measured at two weeks post-procedure<br>4. Acceptability, measured at two weeks post-procedure<br>5. General health Questionnaire-12 item (GHQ-12), measured at baseline and two weeks post-procedure<br>6. Hospital Anxiety and Depression Scale (HADS), measured at baseline and two weeks post-procedure<br>7. Satisfaction with care received before during and after procedure (excellent/very good/good/fair/poor), measured at two weeks post-procedure