Skip to main content
OpenTrials
Completed

NCT Number: NCT05654259

Obesity and OSA in Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Apnea Blood Pressure Body Weight Dyssomnias Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Maternal Obstructive Sleep Apnea Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Institute for Exercise and Environment Medicine (IEEM) at Texas Health Presbyterian Hospital, Dallas, Texas, United States

Loading trial locations.

About this study

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 gestation) and postpartum (6-10 weeks after delivery). Investigator will compare AHI (primary endpoint), the development or worsening of OSA, and pregnancy outcomes in obese and non-obese women with and without weight gain above the Institute of Medicine (IOM) recommended levels. Various body composition areas, (e.g., neck, waist, or hips) that may be associated with risk for sleep apnea will also be measured.

Aim 2: To test the hypothesis that obesity is associated with sympathetic activation, while OSA magnifies this abnormality during pregnancy. Study team will use the state-of-the-art technique of microneurography to measure resting sympathetic activity (primary endpoint) and sympathetic neural responses to physiological stimulations (e.g., mental stress, exercise and upright posture) during early (<12 weeks) and late (30-34 weeks) pregnancy, and postpartum (6-10 weeks post) in obese women with and without OSA and non-obese women without OSA.

Aim 3: To test the hypothesis that corin content is greater in obese than nonobese women during pregnancy, and it is the greatest in obese pregnant women with OSA. Venous blood samples will be taken in women enrolled in Aim 2 study for measurements of serum corin content (primary endpoint) and pregnancy-specific angiogenic factors such as soluble fms-like tyrosine kinase 1, placental growth factor, and soluble endoglin. The relationships between maternal corin content, pregnancy-specific angiogenic factors, sympathetic activity, and BP will be explored.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: Early pregnancy (4-12 weeks gestation)

    The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea

  2. Apnea Hypopnea Index (AHI)

    Time frame: Late pregnancy (30-34 weeks of gestation)

    The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea

  3. Apnea Hypopnea Index (AHI)

    Time frame: Post partum (6-10 weeks after delivery)

    The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea

  4. Resting sympathetic activity

    Time frame: Early pregnancy (< 12 weeks gestation)

    Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.

  5. Resting sympathetic activity

    Time frame: Late pregnancy (30-34 weeks of gestation)

    Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.

  6. Resting sympathetic activity

    Time frame: Post partum (6-10 weeks after delivery)

    Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.

  7. Serum corin content measurement

    Time frame: Early pregnancy (< 12 weeks gestation)

    Serum corin content will be measured by venous blood samples

  8. Serum corin content measurement

    Time frame: Late pregnancy (30-34 weeks of gestation)

    Serum corin content will be measured by venous blood samples

  9. Serum corin content measurement

    Time frame: Post partum (6-10 weeks after delivery)

    Serum corin content will be measured by venous blood samples

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Obesity and Sleep Apnea in Pregnancy

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Dec 16, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.