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Clinical Trials/NCT06164015
NCT06164015
Not yet recruiting
Not Applicable

Association of Acquired Uterine Abnormalities With Recurrent Miscarriage

University Hospitals of Derby and Burton NHS Foundation Trust0 sites400 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent Miscarriage
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Enrollment
400
Primary Endpoint
Prevalence of Acquired Uterine Anomalies
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Endometrial thickness(24 months)
  • Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)(24 months)
  • Endometrial volume(24 months)

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