Preeclampsia Clinical Trial
— OCCPOfficial title:
Optimization of Cervical Collections in Pregnancy
NCT number | NCT06323187 |
Other study ID # | 4656 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | February 28, 2031 |
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.
Status | Not yet recruiting |
Enrollment | 2600 |
Est. completion date | February 28, 2031 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Confirmed pregnancy Before 30w0d gestation for pregnant participants - Regular menses within previous month for non-pregnant participants - 18-45 years old Exclusion Criteria: - Bleeding >5 days in first trimester for pregnant participants - Ruptured membranes for pregnant participants - Currently menstruating for non-pregnant participants |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Dr. Sascha Drewlo |
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. — View Citation
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. — View Citation
Practice Bulletin No. 162: Prenatal Diagnostic Testing for Genetic Disorders. Obstet Gynecol. 2016 May;127(5):e108-e122. doi: 10.1097/AOG.0000000000001405. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cellular content | The number of cells in the cervical sample that express markers for extracellular trophoblast will be determined. | 2 weeks | |
Primary | 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 |
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