[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540925":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":10,"responsibleParty":35,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":53,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":10},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant Participants",null,"Pregnant participants will be randomly assigned to provide a cervical sample using one of the devices\u002Fprocedures for cervical fluid collection.",[13],"Diagnostic Test: Cervical Sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-Pregnant Participants","Non-pregnant participants will be randomly assigned to provide a cervical sample using one of the devices\u002Fprocedures for cervical fluid collection.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Cervical Sampling","Each participant will provide a sample of fluid or mucus collected from the uterine endocervix.",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Sascha Drewlo, PhD","Sunnybrook Research Institute","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","1-416-480-6100","683853","sascha.drewlo@sri.utoronto.ca",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Dr. Sascha Drewlo","Professor","100540925","optimization-of-cervical-collections-in-pregnancy-100540925",false,"NCT06323187","Optimization of Cervical Collections in Pregnancy","OCCP","Inclusion Criteria:\n\n* Confirmed pregnancy Before 30w0d gestation for pregnant participants\n* Regular menses within previous month for non-pregnant participants\n* 18-45 years old\n\nExclusion Criteria:\n\n* Bleeding \\>5 days in first trimester for pregnant participants\n* Ruptured membranes for pregnant participants\n* Currently menstruating for non-pregnant participants",true,"FEMALE","18 Years","45 Years",{"count":51,"type":52},2600,"ESTIMATED","9 Months","OBSERVATIONAL","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.\n\nThis 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.",[57,58,59,60],"Cervix; Pregnancy","Inherited Genetic Conditions (Diagnosis)","Preeclampsia","Fetal Growth Retardation","NOT_YET_RECRUITING","2024-03-14",{"date":64,"type":65},"2024-03-21","ACTUAL",{"date":67,"type":52},"2024-05-01",{"date":69,"type":52},"2031-02-28",{"name":37,"class":6}]