Time Interval for Medical Early AbortionS -TIMES trial v 1.1

• Research type

  Research Study

• Full title

  A randomised controlled trial on Efficacy of mifepristone followed by 6-8 hours versus 24 hours vaginal misoprostol in Early Medical Abortions (< 63 days gestation)

• IRAS ID

  16334

• Contact name

  Janesh Kumar Gupta

• Sponsor organisation

  Calthorpe Clinic

• Eudract number

  2009-010277-21

• ISRCTN Number

  ISRCTN97410750

• Research summary

  Medical abortion using a combination of mifepristone-misoprostol is a safe alternative to surgical abortion before nine weeks of pregnancy. With the introduction of ??lunch time" abortions- a new concept for shortening the time intervals between the two medications is being developed. Currently, the standard time interval is 24 hours but the very short time interval of 6-8 hours needs to be investigated further before it is introduced into routine clinical practice.This randomised controlled study is therefore set out to evaluate the efficacy of 6-8 hours administration of misoprostol against 24 hours (Standard method). The efficacy of the new regimen will also look into patient??s acceptance and satisfaction and the efficacy between the two regimes, while exploring women??s experiences and preferences to different methods of medical abortion.This study will also assess the various follow up methods such as- clinical history, blood tests and ultrasound to find out which is the most reliable method for confirmation of completeness of medical abortion.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/22

• Date of REC Opinion

  22 Jun 2009

• REC opinion

  Further Information Favourable Opinion