Optimization of Cervical Collections in Pregnancy

NCT06323187 | Not Yet Recruiting

• 1 other identifier: 4656
• Study Type: observational
• Target: 2,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus. This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants.

Conditions

Cervix; Pregnancy; Inherited Genetic Conditions (Diagnosis); Preeclampsia; Fetal Growth Retardation

Outcome Measures

Primary Outcomes (2)

• Cellular content

  The number of cells in the cervical sample that express markers for extracellular trophoblast will be determined.

  2 weeks

• Cell-free content

  The concentration of placental biomarkers (e.g., HLA-G, KRT7) in the cell-free supernatant of the cervical sample will be determined. Also nucleic acids derived from the placenta, including fetal DNA and placental RNAs.

  2 weeks

Study Arms (2)

Pregnant Participants

Pregnant participants will be randomly assigned to provide a cervical sample using one of the devices/procedures for cervical fluid collection.

Diagnostic Test: Cervical Sampling

Non-Pregnant Participants

Non-pregnant participants will be randomly assigned to provide a cervical sample using one of the devices/procedures for cervical fluid collection.

Diagnostic Test: Cervical Sampling

Interventions

Cervical Sampling DIAGNOSTIC_TEST

Each participant will provide a sample of fluid or mucus collected from the uterine endocervix.

Non-Pregnant Participants; Pregnant Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women age, 18-45 who are either pregnant before 30w0d gestation or non-pregnant and not menstruating.

You may qualify if:

• Confirmed pregnancy Before 30w0d gestation for pregnant participants
• Regular menses within previous month for non-pregnant participants
• years old

You may not qualify if:

• Bleeding \>5 days in first trimester for pregnant participants
• Ruptured membranes for pregnant participants
• Currently menstruating for non-pregnant participants

Sponsors & Collaborators

• Dr. Sascha Drewlo: lead

Related Publications (3)

• Practice Bulletin No. 162: Prenatal Diagnostic Testing for Genetic Disorders. Obstet Gynecol. 2016 May;127(5):e108-e122. doi: 10.1097/AOG.0000000000001405.

  PMID: 26938573 BACKGROUND

• Drewlo S, Armant DR. Quo vadis, trophoblast? Exploring the new ways of an old cell lineage. Placenta. 2017 Dec;60 Suppl 1(Suppl 1):S27-S31. doi: 10.1016/j.placenta.2017.04.021. Epub 2017 Apr 26.

  PMID: 28483162 BACKGROUND

• Moser G, Drewlo S, Huppertz B, Armant DR. Trophoblast retrieval and isolation from the cervix: origins of cervical trophoblasts and their potential value for risk assessment of ongoing pregnancies. Hum Reprod Update. 2018 Jul 1;24(4):484-496. doi: 10.1093/humupd/dmy008.

  PMID: 29608700 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cervical specimens collected from the uterine cervical canal, similar to collection for a PAP test.

MeSH Terms

Conditions

Disease; Pre-Eclampsia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Sascha Drewlo, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Drewlo, PhD

CONTACT

1-416-480-6100; sascha.drewlo@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2031
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share