Obesity and OSA in Pregnancy

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Dec 8, 2022

Keywords

ClinConnect Summary

Aim 1: To test the hypothesis that maternal obesity increases OSA risk but to a greater extent in obese women with excessive gestational weight gain vs. obese women with normal weight gain vs. non-obese women with excessive weight gain. Study team will enroll early pregnant (≤12 weeks of gestation) obese (pre-pregnancy body mass index ≥30 kg/m2) and non-obese (body mass index 18.5-24.9 kg/m2) women and follow participants throughout gestation. In-home sleep testing will be carried out during all phases of pregnancy: early pregnancy (4-12 weeks gestation), late pregnancy (30-34 weeks of gest...

Gender

FEMALE

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 status
• • Women 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; and
• • Given 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.

Trial Officials