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NCT05654259Completed

Obesity and OSA in Pregnancy

Obesity and Sleep Apnea in Pregnancy

Source: ClinicalTrials.gov · Last updated 15 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
116 (actual)
First submitted
8 Dec 2022
Start date
11 Jul 2018
Primary completion date
30 Jun 2024
Lead sponsor
University of Texas Southwestern Medical Center
Diseases
Obesity
NCT number
NCT05654259

What you commit to

  • Study type: Observational
  • Participants enrolled: 116
  • From 11 Jul 2018 to the primary completion date, 30 Jun 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • Coagulation disorders;
  • 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.

Lab values

  • Kidney disease (serum creatinine \>1.5 mg/dL);
  • Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test glucose level ≥200 mg/dL) or other systemic illness;

Other

  • Current multiple pregnancy;
  • Known major fetal chromosomal or anatomical abnormalities;
  • Recurrent miscarriage (three or more);

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas Southwestern Medical Center - Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Institute for Exercise and Environment Medicine (IEEM) at Texas Health Presbyterian Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.