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NOT YET RECRUITING
NCT06323187

Optimization of Cervical Collections in Pregnancy

Sponsor: Dr. Sascha Drewlo

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

2600

Start Date

2024-05-01

Completion Date

2031-02-28

Last Updated

2024-03-21

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Cervical Sampling

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