Sim (Scratch in Miscarriage) Study (SiM)

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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