Sim (Scratch in Miscarriage) Study

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

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

Conditions
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Recurrent Miscarriage

Intervention / Treatment
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* Other: Endometrial scratch
* Other: Touching the cervix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate after 24 weeks of gestation |  | 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 |  | 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 | 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 | 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 |