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

NCT05825183 | Recruiting

• 1 other identifier: 2023.095
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genetic Anticipation; Immunological Abnormalities

Outcome Measures

Primary Outcomes (2)

• Histopathologic diagnosis of chorionic villi

  Detecting site-to-site heterogeneity and detecting cryptic structural rearrangements, absence of heterozygoisity (AOH), and single-nucleotide variant (SNV).

  31 May 2028

• Immunohistochemistry staining

  immunoassay of maternal decidua

  31 May 2028

Interventions

Ultrasound-guided manual vaccum PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) will be recruited at Obstetrics and Gynaecology in The Prince of Wales Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

• WARBURTON D, FRASER FC. SPONTANEOUS ABORTION RISKS IN MAN: DATA FROM REPRODUCTIVE HISTORIES COLLECTED IN A MEDICAL GENETICS UNIT. Am J Hum Genet. 1964 Mar;16(1):1-25. No abstract available.

  PMID: 14131871 BACKGROUND

• Klentzeris LD, Bulmer JN, Warren MA, Morrison L, Li TC, Cooke ID. Lymphoid tissue in the endometrium of women with unexplained infertility: morphometric and immunohistochemical aspects. Hum Reprod. 1994 Apr;9(4):646-52. doi: 10.1093/oxfordjournals.humrep.a138564.

  PMID: 7519197 BACKGROUND

• Bulmer JN, Morrison L, Longfellow M, Ritson A, Pace D. Granulated lymphocytes in human endometrium: histochemical and immunohistochemical studies. Hum Reprod. 1991 Jul;6(6):791-8. doi: 10.1093/oxfordjournals.humrep.a137430.

  PMID: 1757516 BACKGROUND

• Bulmer JN, Sunderland CA. Immunohistological characterization of lymphoid cell populations in the early human placental bed. Immunology. 1984 Jun;52(2):349-57.

  PMID: 6376338 BACKGROUND

• Starkey PM, Sargent IL, Redman CW. Cell populations in human early pregnancy decidua: characterization and isolation of large granular lymphocytes by flow cytometry. Immunology. 1988 Sep;65(1):129-34.

  PMID: 3181993 BACKGROUND

• Hill JA, Melling GC, Johnson PM. Immunohistochemical studies of human uteroplacental tissues from first-trimester spontaneous abortion. Am J Obstet Gynecol. 1995 Jul;173(1):90-6. doi: 10.1016/0002-9378(95)90175-2.

  PMID: 7631733 BACKGROUND

MeSH Terms

Conditions

Anticipation, Genetic

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pui Wah Jacqueline Chung

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui Wah Jacqueline Chung

CONTACT

35051537; jacquelinechung@cuhk.edu.hk

Mandie Ho

CONTACT

35051764; mandieho@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: May 30, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)