3D Ultrasound to Assess in Recurrent Miscarriage

NCT ID: NCT06164015

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-31

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

Conditions

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Recurrent Miscarriage

Keywords

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Fibroids Polyps Adhesions Adenomyosis Endometrial blood flow

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrent Miscarriage group (study group)

Group of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation.

3D Ultrasound scan with power Doppler angiography

Intervention Type DIAGNOSTIC_TEST

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

3D Ultrasound scan with power Doppler angiography

Intervention Type DIAGNOSTIC_TEST

The study group and the control group will be offered a 3D ultrasound scan as a part of this trial.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Prof Kanna Jayaprakasan

Role: CONTACT

Phone: 0133285643

Email: [email protected]

Kate Threapleton

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 21830244 (View on PubMed)

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.

Reference Type RESULT
PMID: 33712099 (View on PubMed)

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.

Reference Type RESULT
PMID: 29557233 (View on PubMed)

Other Identifiers

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UHDB/2023/056

Identifier Type: -

Identifier Source: org_study_id