3D Ultrasound to Assess in Recurrent Miscarriage

Not yet recruiting

• Conditions: Recurrent Miscarriage
• Interventions: Diagnostic Test: 3D Ultrasound scan with power Doppler angiography

• Registration Number: NCT06164015
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

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

Study Timeline

• Study First Submitted: 2023-09-22
• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recurrent Miscarriage group (study group)	3D Ultrasound scan with power Doppler angiography	Group of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation.
Fertile population group (control group)	3D Ultrasound scan with power Doppler angiography	Group of women with proven fertility with at least one child born at full term

Primary Outcome Measures

Name	Time	Method
Prevalence of Acquired Uterine Anomalies	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

Secondary Outcome Measures

Name	Time	Method
Endometrial volume	24 months	measured by 3D ultrasound (in ml)
Endometrial thickness	24 months	measured by ultrasound (in mm)
Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)	24 months	All three indices as measured by 3D ultrasound using VOCAL software