Clinical Trial: Sim (Scratch in Miscarriage) Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes

Brief Summary:

There is increasing amount of evidence which suggests that miscarriage is related to a primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that endometrial scratch improves live birth in women who underwent IVF.

The aim of the study is to find out if scratch of the endometrium prevents recurrent miscarriage.


Detailed Summary: The Warwick BRU-RH (Biomedical Research Unit- Reproductive Health) hypothesis is that failed pregnancies are the result of failed decidualisation of the endometrium.
Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Current Primary Outcome: Live Birth Rate after 24 weeks of gestation [ Time Frame: from the recruitment of the first patient up to 12 months after the recruitment of last patient. the live birth rate of all the pregnant patients in the study who delivered after 24 weeks will be included in the outcome. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Miscarriage until 23+6 weeks of gestation [ Time Frame: from the recruitment of the first patient and up to 12 months after the recruitment of last patient. the outcomes of all the pregnant patients in the study who delivered up to 23+6 weeks will be included in the outcome. ]
  • Pregnancy complications [ Time Frame: from the recruitment of the first patient and up to 12 months after the recruitment of last patient. The patients who delivered after 24 weeks with a live birth will be included in the outcome and the described outcomes will be measured ]
    Such as SGA(small for gestational age),PET( Pre-eclamptic toxaemia),Abruption, Placenta Praevia, Placenta accreta and Preterm delivery
  • Acceptability of the intervention [ Time Frame: Patient questionnaire will be issued at the time of randomisation. the returned forms up to 4 weeks after randomisation will be analysed and reported. this will be helpful for assessing the patients tolerability of the procedure ]
    To guide future trial set up


Original Secondary Outcome: Same as current

Information By: University Hospitals Coventry and Warwickshire NHS Trust

Dates:
Date Received: February 3, 2016
Date Started: November 2015
Date Completion: September 2017
Last Updated: August 12, 2016
Last Verified: August 2016