Study of Product of Conception Derived From Ultrasound-guided Manual Vacuum Aspiration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorChinese University of Hong Kong
About this trial
Early pregnancy loss is very common, approximately one in four women will experience a miscarriage in their lifetime. The etiology of pregnancy loss remains largely unknown, although genetic, anatomical, endocrinological and immunological abnormalities have been implicated.
It is known that embryonic/fetal chromosomal aberrations contributed to approximately 50% of early pregnancy loss, among which 60-70% were aneuploidies, largely can be detected by the current gold standard karyotyping approach recommended by various international societies. However, the drawbacks of conventional karyotyping include the risk of culture failure, maternal cell contamination (MCC), limited detection resolution (5-10 Mb), and differential growth of specific cell lineages which could hinder the diagnosis of genetic abnormalities, particularly mosaicisms. Additional genetic factors beyond the resolution of karyotyping are not well studied.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women 18 years old or above
Women with miscarriage or TOP who are suitable candidates for MVA
first trimester miscarriage or TOP
No fetal heart beat or TOP in those with CRL 25mm
Disqualifiers
Women who are not feasible for the MVA procedure
cervical stenosis
fibroid uterus >12 weeks in size
known uterine malformation
Trial population
Women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) will be recruited at Obstetrics and Gynaecology in The Prince of Wales Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-guided manual vaccum
Procedure/SurgeryFor managing with miscarriage or termination of pregnancy (TOP) in first trimester loss, ultrasound-guided manual vacuum aspiration (USG-MVA) is one of the treatment options. The USG-MVA device works by aspirating the uterine content via the cannula into the syringe. Furthermore, product of conception derived from USG-MVA can be sent for karyotyping analysis. POCs obtained from MVA procedure were rinsed in normal saline thoroughly in the kidney basin to minimize maternal blood. Chorionic villi were considered as a proxy of fetal genetics, appeared to be yellowish in color and tree-projection-like in appearance, floating on the surface of the waterline. Decidua are originated from the mother, appeared substantive in structure and sank in the basin. The two different types of tissues are separated from each other for different testing.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Histopathologic diagnosis of chorionic villi
Detecting site-to-site heterogeneity and detecting cryptic structural rearrangements, absence of heterozygoisity (AOH), and single-nucleotide variant (SNV).
Time frame
31 May 20282
Immunohistochemistry staining
immunoassay of maternal decidua
Time frame
31 May 2028Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov