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Sim (Scratch in Miscarriage) Study (SiM)

Primary Purpose

Recurrent Miscarriage

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endometrial scratch
Touching the cervix
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Miscarriage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospitals of Coventry and Warwickshire NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

endometrial scratch

touching cervix

Arm Description

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

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

Outcomes

Primary Outcome Measures

Live Birth Rate after 24 weeks of gestation

Secondary Outcome Measures

Miscarriage until 23+6 weeks of gestation
Pregnancy complications
Such as SGA(small for gestational age),PET( Pre-eclamptic toxaemia),Abruption, Placenta Praevia, Placenta accreta and Preterm delivery
Acceptability of the intervention
To guide future trial set up

Full Information

First Posted
February 3, 2016
Last Updated
January 28, 2019
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
University of Warwick
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1. Study Identification

Unique Protocol Identification Number
NCT02681627
Brief Title
Sim (Scratch in Miscarriage) Study
Acronym
SiM
Official Title
Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
University of Warwick

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endometrial scratch
Arm Type
Active Comparator
Arm Description
Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch
Arm Title
touching cervix
Arm Type
Sham Comparator
Arm Description
Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch
Intervention Type
Other
Intervention Name(s)
Endometrial scratch
Intervention Description
If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter
Intervention Type
Other
Intervention Name(s)
Touching the cervix
Intervention Description
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
Primary Outcome Measure Information:
Title
Live Birth Rate after 24 weeks of gestation
Time Frame
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 Measure Information:
Title
Miscarriage until 23+6 weeks of gestation
Time Frame
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.
Title
Pregnancy complications
Description
Such as SGA(small for gestational age),PET( Pre-eclamptic toxaemia),Abruption, Placenta Praevia, Placenta accreta and Preterm delivery
Time Frame
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
Title
Acceptability of the intervention
Description
To guide future trial set up
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Actively trying for a pregnancy Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siobhan Quenby, MD FRCOG
Organizational Affiliation
UHCW NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Coventry and Warwickshire NHS Trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

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Sim (Scratch in Miscarriage) Study

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