Sim (Scratch in Miscarriage) Study

NCT ID: NCT02681627

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-09-01

Brief Summary

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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

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

Conditions

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Recurrent Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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endometrial scratch

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

Group Type ACTIVE_COMPARATOR

Endometrial scratch

Intervention Type OTHER

If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter

touching cervix

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

Group Type SHAM_COMPARATOR

Touching the cervix

Intervention Type OTHER

If patient is randomised to the control arm, she will have speculum examination followed by cleaning of the cervix with a cotton tip dipped in saline

Interventions

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Endometrial scratch

If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter

Intervention Type OTHER

Touching the cervix

If patient is randomised to the control arm, she will have speculum examination followed by cleaning of the cervix with a cotton tip dipped in saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Warwick

OTHER

Sponsor Role collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siobhan Quenby, MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

UHCW NHS Trust

Locations

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University Hospitals of Coventry and Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Rego2015 1630

Identifier Type: -

Identifier Source: org_study_id

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