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

U

University Hospitals of Derby and Burton NHS Foundation Trust

Status

Not yet enrolling

Conditions

Recurrent Miscarriage

Treatments

Diagnostic Test: 3D Ultrasound scan with power Doppler angiography

Study type

Observational

Funder types

Other

Identifiers

NCT06164015
UHDB/2023/056

Details and patient eligibility

About

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.

Full 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

Enrollment

400 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Kate Threapleton; Prof Kanna Jayaprakasan

Data sourced from clinicaltrials.gov

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