Sim (Scratch in Miscarriage) Study (SiM)

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Recurrent Miscarriage

Treatments: Other: Touching the cervix; Other: Endometrial scratch

Study type: Interventional

Funder types: Other

Identifiers

NCT02681627

Rego2015 1630

Details and patient eligibility

About

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.

Full description

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

Enrollment: 109 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups

endometrial scratch

Active Comparator group

Description:

Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch

Treatment:

Other: Endometrial scratch

touching cervix

Sham Comparator group

Description:

Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch

Treatment:

Other: Touching the cervix