Sim (Scratch in Miscarriage) Study

Recurrent Miscarriage Clinical Trial

— SiM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681627
• Other study ID #: Rego2015 1630
• Status: Completed
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2019
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 1, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Coventry and Warwickshire NHS Trust	Coventry	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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