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Recruiting NCT05654259

Obesity and OSA in Pregnancy

Conditions: Obesity, Obesity, Maternal, Obstructive Sleep Apnea, Blood Pressure

Sex: Female
Ages: 18 Years – 64 Years
Enrollment: 300
Sponsor: University of Texas Southwestern Medical Center

Location: United States

Summary

The purposes of this project are 1) to compare the impact of maternal obesity versus excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular risk during pregnancy; and 3) to identify biomarker(s) for obesity-related OSA in pregnant women.

Eligibility Criteria

Inclusion Criteria:Both obese and non-obese (normal weight) early pregnant women aged ≥18 years old will be permitted to participate in this project.No restriction with respect to race and socioeconomic statusWomen with a prior history of complicated pregnancy (i.e., gestational hypertension, preeclampsia, HELLP syndrome, gestational diabetes, preterm birth, intrauterine growth restriction, etc.) will be allowed to participate.Obese women with previously diagnosed OSA will be allowed to participate if they are not currently on any recognized treatments such as Continuous Positive Airway Pressure (CPAP), oral appliances or nasal expiratory positive airway pressure.Those who have had surgery for OSA in the past will be excluded.Women taking low-dose aspirin will be allowed to participate in this project.Exclusion Criteria:Current multiple pregnancy;Known major fetal chromosomal or anatomical abnormalities;Recurrent miscarriage (three or more);Chronic essential hypertension (systolic BP >140 mmHg and/or diastolic BP >90 mmHg);Any evidence of cardiovascular and pulmonary diseases by history or by physical examination;Kidney disease (serum creatinine >1.5 mg/dL);Coagulation disorders;Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test glucose level ≥200 mg/dL) or other systemic illness;Any evidence of neurological disease;Psychiatric disease or psychological disorders;History of drug or alcohol abuse within the last 2 years; andGiven the effects of exercise training on sympathetic neural control, endurance-trained athletes will be excluded. As this project focuses on sleep apnea in pregnancy, Women with other significant sleep disorders such as restless legs syndrome by Rest Leg Syndrome Diagnostic Index and insomnia by the Insomnia Severity Index or Pittsburgh Sleep Quality Index will be excluded; In addition, women who report taking a sleeping aid >1 time per month will be excluded.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05654259). StuddyBuddy aggregates publicly available trial information.