Recurrent Miscarriage3D-ARMNCT06164015
3D Ultrasound to Assess in Recurrent Miscarriage
An observational study of Recurrent Miscarriage, run by University Hospitals of Derby and Burton NHS Foundation Trust.
Trial summary
This observational study aims to compare the prevalence of acquired abnormalities of the uterus (fibroids, polyps, intrauterine adhesions, adenomyosis) in women who have recurrent miscarriages with the fertile population. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- 3D Ultrasound scan with power Doppler angiography
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: The professionals (clinicians, nurses) in the recurrent miscarriage clinic will identify the suitable study population. Suitable controls will be identified in the Gynae clinic,Gynae assessment unit,Gynaecology ward.
Who may be able to join
- Women between the age group of 18-40 years
- Women who have had 2 or more pregnancy losses before 24 weeks of gestation - Study group.
- Women who can provide documented informed consent
- Women with proven fertility with at least one child - Control group
Who cannot join
- 1. Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.
Trial locations and contacts
No sites are listed yet.
Kate Threapleton contact
About this study
Official title: Association of Acquired Uterine Abnormalities With Recurrent Miscarriage
This observational study aims to compare the prevalence of acquired abnormalities of the uterus (fibroids, polyps, intrauterine adhesions, adenomyosis) in women who have recurrent miscarriages with the fertile population.
Read the detailed description
High-quality studies including several meta-analyses have proven the association between congenital uterine anomalies and recurrent miscarriages. Nevertheless, there are limited studies evaluating the impact of acquired uterine anomalies on recurrent miscarriages.
This prospective observational study will aim to compare the prevalence of acquired uterine anomalies between the study group and the control group. The secondary aim will be to compare the Endometrial morphological features like endometrial volume, endometrial and sub-endometrial vascularity between the two groups
- Conditions
- Recurrent Miscarriage
- Being tested
- 3D Ultrasound scan with power Doppler angiography
- Keywords
- Fibroids, Polyps, Adhesions, Adenomyosis, Endometrial blood flow
- Medical subject headings
- Abortion, Habitual, Leiomyoma, Polyps, Tissue Adhesions, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Ultrasound scan with power Doppler angiographyDiagnostic test
The study group and the control group will be offered a 3D ultrasound scan as a part of this trial.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Miscarriage group (study group) | Group of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation. Receives: Diagnostic Test: 3D Ultrasound scan with power Doppler angiography | |
| Fertile population group (control group) | Group of women with proven fertility with at least one child born at full term Receives: Diagnostic Test: 3D Ultrasound scan with power Doppler angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Acquired Uterine Anomalies
Primary outcome will be to compare the prevalence of acquired uterine anomalies (estimated as the proportion of anomalies diagnosed on 3D pelvic ultrasound) between study group and control group
Measured: 24 months
Secondary outcomes (3)
Endometrial thickness
measured by ultrasound (in mm)
Measured: 24 months
Endometrial volume
measured by 3D ultrasound (in ml)
Measured: 24 months
Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)
All three indices as measured by 3D ultrasound using VOCAL software
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164015
- Sponsor's protocol ID
- UHDB/2023/056
- Acronym
- 3D-ARM
- Status last verified
- Dec 2023
- First submitted
- 22 Sep 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
PubMed 21830244Carbonnel M, Pirtea P, de Ziegler D, Ayoubi JM. Uterine factors in recurrent pregnancy losses. Fertil Steril. 2021 Mar;115(3):538-545. doi: 10.1016/j.fertnstert.2020.12.003.
PubMed 33712099Dobson SJA, Jayaprakasan KM. Aetiology of recurrent miscarriage and the role of adjuvant treatment in its management: a retrospective cohort review. J Obstet Gynaecol. 2018 Oct;38(7):967-974. doi: 10.1080/01443615.2018.1424811. Epub 2018 Mar 20.
PubMed 29557233
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Acquired Uterine Abnormalities With Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT06164015
- Acronym / sponsor ID
- 3D-ARM / UHDB/2023/056
- Conditions
- Recurrent Miscarriage
- Keywords
- Fibroids, Polyps, Adhesions, Adenomyosis, Endometrial blood flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Dec 2023 (actual)
- 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.
This observational study aims to compare the prevalence of acquired abnormalities of the uterus (fibroids, polyps, intrauterine adhesions, adenomyosis) in women who have recurrent miscarriages with the fertile population.
Detailed description
High-quality studies including several meta-analyses have proven the association between congenital uterine anomalies and recurrent miscarriages. Nevertheless, there are limited studies evaluating the impact of acquired uterine anomalies on recurrent miscarriages.
This prospective observational study will aim to compare the prevalence of acquired uterine anomalies between the study group and the control group. The secondary aim will be to compare the Endometrial morphological features like endometrial volume, endometrial and sub-endometrial vascularity between the two groups
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Miscarriage group (study group) | – | Diagnostic Test: 3D Ultrasound scan with power Doppler angiographyGroup of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation. |
| Fertile population group (control group) | – | Diagnostic Test: 3D Ultrasound scan with power Doppler angiographyGroup of women with proven fertility with at least one child born at full term |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The professionals (clinicians, nurses) in the recurrent miscarriage clinic will identify the suitable study population. Suitable controls will be identified in the Gynae clinic,Gynae assessment unit,Gynaecology ward.
Key inclusion criteria (4 listed)
- Women between the age group of 18-40 years
- Women who have had 2 or more pregnancy losses before 24 weeks of gestation - Study group.
- Women who can provide documented informed consent
- Women with proven fertility with at least one child - Control group
Key exclusion criteria (1 listed)
- 1. Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.
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 |
|---|---|---|
| 3D Ultrasound scan with power Doppler angiographyThe study group and the control group will be offered a 3D ultrasound scan as a part of this trial. | Diagnostic test | Fertile population group (control group), Recurrent Miscarriage group (study group) |
Primary outcome
Prevalence of Acquired Uterine Anomalies
Time frame: 24 months
Primary outcome will be to compare the prevalence of acquired uterine anomalies (estimated as the proportion of anomalies diagnosed on 3D pelvic ultrasound) between study group and control group
3 secondary outcomes
Endometrial thickness
Time frame: 24 months
Endometrial volume
Time frame: 24 months
Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Results publication: PubMed 21830244Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
- Results publication: PubMed 33712099Carbonnel M, Pirtea P, de Ziegler D, Ayoubi JM. Uterine factors in recurrent pregnancy losses. Fertil Steril. 2021 Mar;115(3):538-545. doi: 10.1016/j.fertnstert.2020.12.003.
- Results publication: PubMed 29557233Dobson SJA, Jayaprakasan KM. Aetiology of recurrent miscarriage and the role of adjuvant treatment in its management: a retrospective cohort review. J Obstet Gynaecol. 2018 Oct;38(7):967-974. doi: 10.1080/01443615.2018.1424811. Epub 2018 Mar 20.
- Individual participant dataSharing planned: No
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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.
Kate Threapleton contact
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Miscarriage, run by University Hospitals of Derby and Burton NHS Foundation Trust.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof Kanna Jayaprakasan (0133285643, kanna.jayaprakasan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Acquired Uterine Anomalies (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06164015, which also lists 3 linked publications.
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 11 Dec 2023.