Sim (Scratch in Miscarriage) Study

Not Applicable

Completed

• Conditions: Recurrent Miscarriage
• Interventions: Other: Endometrial scratch; Other: Touching the cervix

• Registration Number: NCT02681627
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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 Description

The Warwick BRU-RH (Biomedical Research Unit- Reproductive Health) hypothesis is that failed pregnancies are the result of failed decidualisation of the endometrium.

Study Timeline

• Study Start: 2015-11-30
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Primary Completion: 2017-06-26
• Study Completion: 2017-09-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

1. Provision of written informed consent
2. Actively trying for a pregnancy

Exclusion Criteria

1. No active treatment in pregnancy
2. Inherited or acquired thrombophilia
3. Medical conditions- diabetes,hypertension,thyroid disorders
4. inability to tolerate internal examinations
5. uterine anomalies
6. Previous entry or randomisation in the present trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endometrial scratch	Endometrial scratch	Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch
touching cervix	Touching the cervix	Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch

Primary Outcome Measures

Name	Time	Method
Live Birth Rate after 24 weeks of gestation	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.

Secondary Outcome Measures

Name	Time	Method
Miscarriage until 23+6 weeks of gestation	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.
Acceptability of the intervention	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
Pregnancy complications	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

Trial Locations

Locations (1)

University Hospitals of Coventry and Warwickshire NHS Trust; 🇬🇧 Coventry, West Midlands, United Kingdom