RecruitingNCT05825183

Study of Product of Conception Derived From Ultrasound-guided Manual Vacuum Aspiration


Sponsor

Chinese University of Hong Kong

Enrollment

100 participants

Start Date

May 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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
  • incomplete miscarriage or TOP with POG <5cm
  • hemodynamically stable,
  • tolerates well with speculum examination

Exclusion Criteria9

  • Women who are not feasible for the MVA procedure
  • cervical stenosis
  • fibroid uterus >12 weeks in size
  • known uterine malformation
  • bleeding disorder
  • clinically sepsis
  • inability to tolerate pelvic examination
  • History of psychological/ psychiatric problem
  • Patient refusal

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Interventions

PROCEDUREUltrasound-guided manual vaccum

For 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.


Locations(1)

Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT05825183


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