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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT06932250
Eligibility Criteria:
Inclusion Criteria:
* Women with obesity (self-reported pre-pregnancy body mass index ≥30 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old will be enrolled.
* Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg)42 pregnant women will be enrolled if they are not on any antihypertensive drug treatment.
* We will enroll both nulliparous and multiparous women.
* There is no restriction regarding race/ethnicity and socioeconomic status.
* Women with a history of HDP will be allowed to participate.
* Women taking low-dose aspirin will be allowed to participate and aspirin use will be documented.
Exclusion Criteria:
* Current multiple pregnancies (e.g., twins, triplets, etc.).
* Known major fetal chromosomal or anatomical abnormalities diagnosed during the study.
* Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome).
* Office sitting BP \<100/55 mmHg or \>150/100 mmHg (for safety reasons).
* Severe sleep apnea (an apnea-hypopnea index ≥30 events/h43 based on the results from in-home sleep testing) or previously diagnosed and treated sleep apnea.
* Evidence of cardiovascular, pulmonary, or neurological diseases.
* Diabetes mellitus or a history of gestational diabetes (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
* Kidney disease (serum creatinine \>0.9 mg/dL).44, 45
* Clinical known deep vein thrombosis, clinical symptoms and history of deep vein thrombosis, or dermatological lesions.
* History of drug or alcohol abuse within the last 2 years.
* Current tobacco use.
* Pregnant women who do not have air conditioning at home during summer (for safety reasons).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06932250
Study Brief:
Protocol Section:
NCT06932250