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Optimization of Cervical Collections in Pregnancy

NCT06323187 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2600

Last updated 2024-03-21

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Cervical Sampling

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

Sponsors & Collaborators

  • Dr. Sascha Drewlo

    lead OTHER

Principal Investigators

  • Sascha Drewlo, PhD · Sunnybrook Research Institute

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-02-28
Completion
2031-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06323187 on ClinicalTrials.gov