Sim (Scratch in Miscarriage) Study

University Hospitals Coventry and Warwickshire NHS Trust109 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

109

Conditions

Recurrent Miscarriage

Interventions

Endometrial scratchOTHER

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

Touching the cervixOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals of Coventry and Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom

Outcomes

Primary Outcomes

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

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.

Pregnancy complications

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

Acceptability of the intervention

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.