NCT06164015

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

September 22, 2023

Last Update Submit

December 1, 2023

Conditions

Recurrent Miscarriage

Keywords

FibroidsPolypsAdhesionsAdenomyosisEndometrial blood flow

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Endometrial thickness

    24 months

  • Endometrial volume

    24 months

  • Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)

    24 months

Study Arms (2)

Recurrent Miscarriage group (study group)

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

Fertile population group (control group)

Group of women with proven fertility with at least one child born at full term

Diagnostic Test: 3D Ultrasound scan with power Doppler angiography

Interventions

3D Ultrasound scan with power Doppler angiographyDIAGNOSTIC_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)Recurrent Miscarriage group (study group)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale gender
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The professionals (clinicians, nurses) in the recurrent miscarriage clinic will identify the suitable study population. Suitable controls will be identified in the Gynae clinic,Gynae assessment unit,Gynaecology ward.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21830244RESULT

  • 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.

    PMID: 33712099RESULT

  • 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.

    PMID: 29557233RESULT

MeSH Terms

Conditions

Abortion, HabitualLeiomyomaPolypsTissue AdhesionsAdenomyosis

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCicatrixFibrosisPathologic ProcessesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Central Study Contacts

Prof Kanna Jayaprakasan

CONTACT

0133285643kanna.jayaprakasan@nhs.net

Kate Threapleton

CONTACT

uhdb.sponsor@nhs.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

December 11, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share