Clinical trial NCT06164015: 3D Ultrasound to Assess in Recurrent Miscarriage
Official title: Association of Acquired Uterine Abnormalities With Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Recurrent Miscarriage
Keywords: Fibroids
Polyps
Adhesions
Adenomyosis
Endometrial blood flow
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Acquired Uterine Anomalies
timeFrame: 24 months
Secondary outcomes:
measure: Endometrial thickness
timeFrame: 24 months
measure: Endometrial volume
timeFrame: 24 months
measure: Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.