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Completed

NCT Number: NCT02681627

Sim (Scratch in Miscarriage) Study

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.

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Key information

Conditions

Recurrent Miscarriage Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endometrial scratch

Other

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

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

  • University of Warwick

Registry information

Official study title

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

Acronym: SiM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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