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| Name | Class |
|---|---|
| University of Warwick | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometrial scratch | Active Comparator | Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch |
|
| touching cervix | Sham Comparator | Patient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial scratch | Other | If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siobhan Quenby, MD FRCOG | UHCW NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Coventry and Warwickshire NHS Trust | Coventry | West Midlands | CV2 2DX | United Kingdom |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
|
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 |