Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04077060
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women with singleton gestations
* ≤12 6/7 weeks of gestation
* Normal ultrasound examination at the time of randomization
* \>18 \<45 years
* Crown-rump length (CRL) \<84 mm at the time of randomization
Exclusion Criteria:
* Multiple gestations, including vanishing twins
* \>12 6/7 weeks of gestation
* Ectopic pregnancy
* Abnormal ultrasound examination at the time of first prenatal visit
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
* Women who have already planned for invasive prenatal testing, e.g. for a history of prior child or pregnancy with chromosomal or genetic abnormalities
* CRL \>84mm at the time of randomization
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04077060
Study Brief:
Protocol Section:
NCT04077060