3D Ultrasound to Assess in Recurrent Miscarriage

Recurrent Miscarriage Clinical Trial

— 3D-ARM  

Official title:

Association of Acquired Uterine Abnormalities With Recurrent Miscarriage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164015
• Other study ID #: UHDB/2023/056
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: Prof Kanna Jayaprakasan
• Phone: 0133285643
• Email: kanna.jayaprakasan[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrence
• Recurrent Miscarriage

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Endometrial thickness	measured by ultrasound (in mm)	24 months
Secondary	Endometrial volume	measured by 3D ultrasound (in ml)	24 months
Secondary	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