Recurrent MiscarriageSiMNCT02681627
Sim (Scratch in Miscarriage) Study
A study testing Endometrial scratch and Touching the cervix in people with Recurrent Miscarriage, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- Endometrial scratch and Touching the cervix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2015to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provision of written informed consent
- Actively trying for a pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Official title: Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
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.
Read the 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.
- Conditions
- Recurrent Miscarriage
- Being tested
- Endometrial scratch, Touching the cervix
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| endometrial scratch | Active comparator | Patient will be randomised to the intervention arm which is the luteal phase endometrial scratch Receives: Other: 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 Receives: Other: Touching the cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate after 24 weeks of gestation
Measured: 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 (3)
Miscarriage until 23+6 weeks of gestation
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start30 Nov 2015
- Primary completion26 Jun 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick
- Responsible party
- Sponsor
- Investigators
- Siobhan Quenby, MD FRCOG, Principal investigator, UHCW NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681627
- Sponsor's protocol ID
- Rego2015 1630
- Acronym
- SiM
- Status last verified
- Jan 2019
- First submitted
- 3 Feb 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT02681627
- Acronym / sponsor ID
- SiM / Rego2015 1630
- Conditions
- Recurrent Miscarriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University of Warwick
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial scratch | Active comparator | Other: Endometrial scratchPatient will be randomised to the intervention arm which is the luteal phase endometrial scratch |
| touching cervix | Sham comparator | Other: Touching the cervixPatient will have a speculum examination and cleaning of the cervix with cotton tip with saline but no scratch |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of written informed consent
- Actively trying for a pregnancy
Key exclusion criteria (6 listed)
- No active treatment in pregnancy
- Inherited or acquired thrombophilia
- Medical conditions- diabetes,hypertension,thyroid disorders
- inability to tolerate internal examinations
- uterine anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial scratchIf patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter | Other | endometrial scratch |
| Touching the cervixIf 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 | Other | touching cervix |
Primary outcome
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.
3 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan Quenby, MD FRCOG principal investigator
UHCW NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial scratch and Touching the cervix in people with Recurrent Miscarriage, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.