SiM: Sim (Scratch in Miscarriage) Study
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [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
- Acceptability of the intervention [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Siobhan Quenby, MD FRCOG, UHCW NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Rego2015 1630