Sim (Scratch in Miscarriage) Study (SiM)

January 28, 2019 updated by: University Hospitals Coventry and Warwickshire NHS Trust

Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • University Hospitals of Coventry and Warwickshire NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: endometrial scratch
Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch
Other: Endometrial scratch
If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter
Sham Comparator: touching cervix
Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
Such as SGA(small for gestational age),PET( Pre-eclamptic toxaemia),Abruption, Placenta Praevia, Placenta accreta and Preterm delivery
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
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
To guide future trial set up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Collaborators

University of Warwick

Investigators

  • Principal Investigator: Siobhan Quenby, MD FRCOG, UHCW NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Actual)

June 26, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rego2015 1630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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