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Clinical Trials/EUCTR2009-010277-21-GB
EUCTR2009-010277-21-GB
Active, not recruiting
Not Applicable

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

Calthorpe Clinic0 sitesApril 16, 2009
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ConditionsMedical termination of pregnancies before nine weeks of pregnancy
DrugsMifegyneCytotec

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medical termination of pregnancies before nine weeks of pregnancy
Sponsor
Calthorpe Clinic
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Calthorpe Clinic

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Outcomes

Primary Outcomes

Not specified

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