A Randomised Controlled Trial on Efficacy of mifepristone followed by 6-8 hours versus 24 hours vaginal misoprostol in Early Pregnancy Abortions (< 63 days gestations) - TIMES study
- Conditions
- Medical termination of pregnancies before nine weeks of pregnancy
- Registration Number
- EUCTR2009-010277-21-GB
- Lead Sponsor
- Calthorpe Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1.Women over the age of 18 years and eligible for legal termination of pregnancy
2.Request for medical abortion
3.Duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
4.If treatment with misoprostol should fail, agrees to surgical termination of pregnancy and repeat medical methods
5.Willing and consent to participate after the study has been explained
6.Haemoglobin higher than 8.0g/l
Are the trial subjects under 18? no
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
1.Any indication of serious past or present ill health will be considered contraindication for recruitment to the study
2.In conditions where medical abortion is considered a risk than benefits as in
a.Allergy towards mifepristone or misoprostol
b.Medical disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) or prostaglandins (mitral stenosis, sickle cell anaemia, diastolic pressure over 90 mmHg, systolic blood pressure lower than 90 mmHg measured with a traditional instrument)
3.The presence of an Intrauterine Device (IUD) in utero
4.Breastfeeding
5. Previous surgery of uterus/uterine cervix is a relative contraindication. However, previous lower segment caesarean section does not need to be a contraindication.
6.Suspicion of any pathology of pregnancy (e.g. molar, non-viable pregnancy, threatened abortion)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary outcome is the proportion of complete abortions where no further medical or surgical intervention beyond the initial dose of vaginal misoprostol is required.;Secondary Objective: The secondary outcome measures are: induction to abortion interval, adverse effects, pain, bleeding and acceptability of women towards the new regimen.;Primary end point(s): Completeness of abortion
- Secondary Outcome Measures
Name Time Method