3D Ultrasound to Assess in Recurrent Miscarriage

Study Overview
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Brief Summary
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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
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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

Official Title
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Association of Acquired Uterine Abnormalities With Recurrent Miscarriage

Conditions
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Recurrent Miscarriage

Intervention / Treatment
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* Diagnostic Test: 3D Ultrasound scan with power Doppler angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recurrent Miscarriage group (study group)<br>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<br>* The study group and the control group will be offered a 3D ultrasound scan as a part of this trial.<br>|
| Fertile population group (control group)<br>Group of women with proven fertility with at least one child born at full term | Diagnostic Test: 3D Ultrasound scan with power Doppler angiography<br>* The study group and the control group will be offered a 3D ultrasound scan as a part of this trial.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids, Polyps, Adhesions, Adenomyosis, Endometrial blood flow