Status:
COMPLETED
Ensuring Patients' Informed Access to Noninvasive Prenatal Testing
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Indiana University
National Human Genome Research Institute (NHGRI)
Conditions:
Genetic Disease
Genetic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Noninvasive prenatal genetic testing (NIPT) is an important new screening test option provided to pregnant women in the first trimester of pregnancy. The advantage of this screen is that is provides i...
Detailed Description
Noninvasive prenatal genetic testing (NIPT), also known as cell-free fetal DNA screening, has dramatically altered the delivery of prenatal care. Prior to NIPT, fetal aneuploidy risk was assessed usin...
Eligibility Criteria
Inclusion
- I. Pregnant women
- Inclusion criteria:
- 18 years of age or older
- Present for their initial prenatal visit care with one of the providers enrolled in the study
- Able to provide consent to participate in the study
- Available for a follow up in the 1st or 2nd trimester of pregnancy
- Have a viable intrauterine pregnancy
- Present for care between 7-12 weeks estimated gestation age (EGA)
- Since criteria 5 and 6 will not be determined until the conclusion of the first prenatal visit, women who meet criteria 1-4 will be eligible for participation.
- Exclusion Criteria:
- Women who are:
- Less than 18 years of age
- Not currently pregnant or an intrauterine pregnancy has not yet been established
- Inability to provide informed consent for research participation
- II. Self-identified partners of pregnant women
- Inclusion criteria:
- 18 years of age or older
- The male or female partner (such as partner or mother/aunt/grandmother serving in the role of primary collaborative decision-maker in place of a partner) of a pregnant woman who has participated in the research
- Participating in decision-making about the pregnancy
- Ability to read and speak English
- Ability to provide informed consent for research participation
- Exclusion criteria:
- Younger than 18 years of age
- Not currently involved in the pregnancy or decision-making about prenatal care
- Inability to speak or read English
- Inability to provide informed consent for research participation
- III. Prenatal healthcare providers
- Inclusion criteria:
- Board certified or board-eligible CNM, OB/GYNs or MFMs
- Deliver outpatient prenatal care at one of the regional practices of the Cleveland Clinic
- Able to read and speak English
- Able to provide consent for research participation
- Exclusion criteria:
- OB/GYNs who do not currently provide prenatal care
- Medical students, residents, and fellows
- Hospitalists who do not provide outpatient obstetric care
Exclusion
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT03420274
Start Date
February 19 2018
End Date
June 15 2023
Last Update
June 27 2023
Active Locations (2)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195