3D Ultrasound to Assess in Recurrent Miscarriage (3D-ARM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Miscarriage
• Intervention / Treatment: Diagnostic test: 3D Ultrasound scan with power Doppler angiography

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Prof Kanna Jayaprakasan; Phone Number: 0133285643; Email: kanna.jayaprakasan@nhs.net
• Study Contact Backup: Name: Kate Threapleton; Email: uhdb.sponsor@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recurrent Miscarriage group (study group); Group of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation.	Diagnostic test: 3D 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.
Fertile population group (control group); Group of women with proven fertility with at least one child born at full term	Diagnostic test: 3D 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness	measured by ultrasound (in mm)	24 months
Endometrial volume	measured by 3D ultrasound (in ml)	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	24 months

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

Publications and helpful links

General 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.
• Carbonnel 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.
• Dobson 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adhesions; Adenomyosis; Fibroids; Polyps; Endometrial blood flow
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Recurrence; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: UHDB/2023/056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No