Abortion, Spontaneous Clinical Trial
Official title:
The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage.
The objectives of this study are to establish the accuracy of ultrasound for the diagnosis of HMs, assess prevalence of these ultrasound features in early pregnancy failure (missed-miscarriages and incomplete miscarriages), and establish which ultrasound signs are the best predictor of HMs on histopathology. The findings of this study will allow us to improve the early diagnosis of HMs by ultrasound therefore allowing us to tailor our counselling and clinical management. All women attending the EPUs and with findings of an early embryonic demise or incomplete miscarriage on transvaginal scan (either by dates or by scan findings) will be eligible to take part in the study. The NICE criteria to diagnose miscarriage will be used. Diagnostic criteria derived from retrospective studies will be used to make the diagnosis of suspected HMs on ultrasound and the presence or absence of these features specifically noted. All participants will be scanned by specialist Gynaecologists who are members of the research team, or the direct clinical care team. Women with suspected HMs on ultrasound will be advised to undergo surgical management of miscarriage, which is in line with current national clinical guidance and maximises the chance of histological diagnosis. All other participants will be offered surgical, medical or expectant management as per standard clinical practice. All women who opt for surgical management, or in whom any pregnancy tissue is available, will have their pregnancy tissue sent for histology, as per national guidance. We will then compare the ultrasound findings with the final histological diagnosis for those women with histopathology specimens and will phone those participants without histopathology specimens to check that their pregnancy tests have reverted to negative 3 weeks after their miscarriage so as to exclude persistent GTN as per standard clinical practice. In addition to this we will perform a blood test for checking pregnancy hormones, beta HCG to assess the correlation between these levels and histologically diagnosed hydatiform moles. All eligible women will be invited to participate in the study and be provided with written consent to have their clinical data included in the study following their ultrasound scan. Participation in the study will be voluntary and refusal to participate will not affect patients' care. Furthermore, taking part in the study will involve an additional blood test, but no other additional interventions over their routine clinical care; however, it will include personal data collection for the purpose of the study. All identifiable data will be anonymised. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05449171 -
High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
|
N/A | |
Active, not recruiting |
NCT05896657 -
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
|
N/A | |
Active, not recruiting |
NCT03736681 -
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage
|
Phase 1 | |
Completed |
NCT03636451 -
Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
|
Phase 3 | |
Completed |
NCT01335802 -
Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy
|
||
Completed |
NCT04446572 -
Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin
|
Phase 2 | |
Completed |
NCT01033903 -
Optimal Treatment of Miscarriage
|
N/A | |
Withdrawn |
NCT02328742 -
Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
|
N/A | |
Completed |
NCT01762098 -
Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization
|
N/A | |
Active, not recruiting |
NCT04360564 -
RPL: Interval to Live Birth and Adverse Perinatal Outcomes
|
||
Completed |
NCT04791020 -
Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
|
N/A | |
Recruiting |
NCT03220750 -
University Hospital Advanced Age Pregnant Cohort
|
N/A | |
Completed |
NCT01904669 -
Internet-based Study of Fertility and Early Pregnancy (PEEPS)
|
N/A | |
Not yet recruiting |
NCT00491270 -
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
|
Phase 3 | |
Active, not recruiting |
NCT02434900 -
Vitamin D and Angiogenic Markers in Odense Child Cohort 1
|
N/A | |
Completed |
NCT03703401 -
The Role of Hydrosalpinx in Recurrent Miscarriage
|
||
Completed |
NCT01788540 -
Intralipid for Recurrent Miscarriage
|
Phase 4 | |
Recruiting |
NCT02633475 -
Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk
|
N/A | |
Completed |
NCT02761772 -
Early Pregnancy Cohort and Preimplantation Factor
|
||
Not yet recruiting |
NCT00256009 -
Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
|
Phase 4 |