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:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04173559
Eligibility Criteria:
Inclusion Criteria:
* At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m\^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of \>/= 14 (10-question scale)
* Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
* Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
* No structural abnormalities or aneuploidy
* Ability to communicate in and provide consent in English
* Maternal age 18 to 51 years of age
* Owns smartphone compatible with wrist-based activity tracker (over 200 devices supported)
Exclusion Criteria:
* Women pregnant with multifetal gestations
* Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
* Planned delivery prior to 36 weeks' of gestation
* Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
51 Years
Study:
NCT04173559
Study Brief:
Protocol Section:
NCT04173559