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Sim (Scratch in Miscarriage) Study (SiM)

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ClinicalTrials.gov Identifier: NCT02681627
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
University of Warwick
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

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.


Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Other: Endometrial scratch Other: Touching the cervix Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681627


Locations
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United Kingdom
University Hospitals of Coventry and Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Investigators
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Principal Investigator: Siobhan Quenby, MD FRCOG UHCW NHS Trust

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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT02681627     History of Changes
Other Study ID Numbers: Rego2015 1630
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications