Sim (Scratch in Miscarriage) Study

NCT02681627 | Completed

• 1 other identifier: Rego2015 1630
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Miscarriage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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

• 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

Study Arms (2)

endometrial scratch

ACTIVE COMPARATOR

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

Other: Endometrial scratch

touching cervix

SHAM COMPARATOR

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

Other: Touching the cervix

Interventions

Endometrial scratch OTHER

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

endometrial scratch

Touching the cervix 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

touching cervix

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent
• Actively trying for a pregnancy

You may not qualify if:

• No active treatment in pregnancy
• Inherited or acquired thrombophilia
• Medical conditions- diabetes,hypertension,thyroid disorders
• inability to tolerate internal examinations
• uterine anomalies
• Previous entry or randomisation in the present trial

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator

Study Sites (1)

University Hospitals of Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Siobhan Quenby, MD FRCOG

  UHCW NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 12, 2016
• Study Start: November 30, 2015
• Primary Completion: June 26, 2017
• Study Completion: September 1, 2017
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

GB (1)