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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recurrent Miscarriage group (study group) | Group of women who have experienced 2 or more pregnancy loss of less than 24 weeks gestation. |
| |
| Fertile population group (control group) | Group of women with proven fertility with at least one child born at full term |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Ultrasound scan with power Doppler angiography | Diagnostic Test | The study group and the control group will be offered a 3D ultrasound scan as a part of this trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | measured by ultrasound (in mm) | 24 months |
| Endometrial volume | measured by 3D ultrasound (in ml) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.
Female gender
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof Kanna Jayaprakasan | Contact | 0133285643 | kanna.jayaprakasan@nhs.net | |
| Kate Threapleton | Contact | uhdb.sponsor@nhs.net |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21830244 | Result | 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. | |
| 33712099 | Result | 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. |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D007889 | Leiomyoma |
| D011127 | Polyps |
| D000267 | Tissue Adhesions |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| 29557233 | Result | 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. |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |