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3D Ultrasound to Assess in Recurrent Miscarriage

Association of Acquired Uterine Abnormalities With Recurrent Miscarriage

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06164015
Acronym
3D-ARM
Enrollment
400
Registered
2023-12-11
Start date
2023-12-01
Completion date
2025-12-31
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Miscarriage

Keywords

Fibroids, Polyps, Adhesions, Adenomyosis, Endometrial blood flow

Brief 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.

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

Interventions

DIAGNOSTIC_TEST3D Ultrasound scan with power Doppler angiography

The study group and the control group will be offered a 3D ultrasound scan as a part of this trial.

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Women between the age group of 18-40 years 2. Women who have had 2 or more pregnancy losses before 24 weeks of gestation - Study group. 3. Women who can provide documented informed consent 4. Women with proven fertility with at least one child - Control group

Exclusion criteria

1\. Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Acquired Uterine Anomalies24 monthsPrimary 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

Secondary

MeasureTime frameDescription
Endometrial thickness24 monthsmeasured by ultrasound (in mm)
Endometrial volume24 monthsmeasured by 3D ultrasound (in ml)
Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)24 monthsAll three indices as measured by 3D ultrasound using VOCAL software

Contacts

Primary ContactProf Kanna Jayaprakasan
kanna.jayaprakasan@nhs.net0133285643
Backup ContactKate Threapleton
uhdb.sponsor@nhs.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026