Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination: a randomized, placebo-controlled, multicentre trial - Two doses and two routes of misoprostol

• Conditions: Termination of early pregnancy

• Registration Number: EUCTR2006-002596-40-SE
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 3008

Inclusion Criteria

- good general health
- older than the age of legal consent
- requesting abortion and eligible for legal termination of pregnancy
- on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
- the duration of the pregnancy corresponds to the length of amenorrhoea when verified with ultrasound, if the gestational length according to ultrasound measurements differ more than 4 days, the ultrasound dating should be used
- the pregnancy is single and intrauterine (single sac)
- if treatment with misoprostol should fail agrees to surgical termination of pregnancy
- willing and able to participate (return to follow-up) after the study has been explained
- haemoglobin higher than 90 g/l.
ed
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study.
In particular:
- allergy towards mifepristone or misoprostol
- a history or evidence of 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 mm Hg, systolic blood pressure lower than 90 mm Hg measured with a traditional instrument)
- a history or evidence of thrombo-embolism, severe or recurrent liver disease
- has a medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion
- uterine fibroids are relative contraindications (women with fibroids that are likely to affect bleeding or contractility should be excluded)
- the presence of an IUD in utero
- breastfeeding
- previous surgery of uterus/uterine cervix is a relative contraindication. However, previous low-segment caesarean section does not need to be a contra-indication
- suspicion of any pathology of pregnancy (e.g. mola, non-viable pregnancy, threatened abortion)
- in case difficulties are anticipated in the follow-up of the woman (e.g. lives too far).

Women older than 35 years can be recruited for the present trial provided they do not smoke, their diastolic blood pressure is <90mmHg and have no known risk facgtor for cardiovascular disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the present randomized trial is to compare four misoprostol regimens when administered either sublingually or vaginally 36-48 hours after 200 mg of mifepristone, among women with a gestational age of up to 63 days. The four regimens will be compared in respect of the following main outcomes (i) their effectiveness to induce complete abortion; (ii) induction-to-abortion interval, when possible: (iii) the occurrence of side-effects; and (iv) women's perceptions.;Secondary Objective: ;Primary end point(s): Termination of pregnancy<br><br>Women will be followed up for six weeks after the treatment.<br><br>For those who require vacuum aspiration, the study will end on the day of the procedure.