Obesity and OSA in Pregnancy

NCT05654259 | Completed

• 1 other identifier: STU 062018-089
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity; Obesity, Maternal; Obstructive Sleep Apnea; Blood Pressure

Keywords

obesity; pregnancy; sleep apnea; blood pressure

Outcome Measures

Primary Outcomes (9)

• Apnea Hypopnea Index (AHI)

  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

  Early pregnancy (4-12 weeks gestation)

• Apnea Hypopnea Index (AHI)

  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

  Late pregnancy (30-34 weeks of gestation)

• Apnea Hypopnea Index (AHI)

  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

  Post partum (6-10 weeks after delivery)

• Resting sympathetic activity

  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.

  Early pregnancy (< 12 weeks gestation)

• Resting sympathetic activity

  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.

  Late pregnancy (30-34 weeks of gestation)

• Resting sympathetic activity

  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.

  Post partum (6-10 weeks after delivery)

• Serum corin content measurement

  Serum corin content will be measured by venous blood samples

  Early pregnancy (< 12 weeks gestation)

• Serum corin content measurement

  Serum corin content will be measured by venous blood samples

  Late pregnancy (30-34 weeks of gestation)

• Serum corin content measurement

  Serum corin content will be measured by venous blood samples

  Post partum (6-10 weeks after delivery)

Study Arms (7)

obese women with normal gestational weight gain

obese women (body mass index ≥30 kg/m2) with weight gain 5-9 kg

obese women excessive gestational weight gain

obese women (body mass index ≥30 kg/m2) with weight gain \>9 kg

non-obese women with normal gestational weight gain

non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain 11.5-16 kg

non-obese women with excessive weight gain

non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain \>16 kg

obese women with OSA

obese women (body mass index ≥30 kg/m2) with Obstructive Sleep Apnea (OSA) (Apnea and Hypopnea Index (AHI) ≥5 events/hr

obese women without OSA

obese women (body mass index ≥30 kg/m2) without Obstructive Sleep Apnea (OSA) (AHI \<5 events/ hr)

non-obese women without OSA

non-obese women without OSA (AHI \<5 events/ hr)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Study includes all women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese and non-obese pregnant women with and without excessive gestational weight gain; Obese and non-obese pregnant women with and without OSA

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Institute for Exercise and Environment Medicine (IEEM) at Texas Health Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Pregnancy in Obesity; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Qi Fu, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Internal Medicine

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: July 11, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)