Obesity and OSA in Pregnancy (NCT05654259) | Clinical Trial Compass
CompletedNot Applicable
Obesity and OSA in Pregnancy
United States116 participantsStarted 2018-07-11
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 alcoh…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apnea Hypopnea Index (AHI)
Timeframe: Early pregnancy (4-12 weeks gestation)
2
Apnea Hypopnea Index (AHI)
Timeframe: Late pregnancy (30-34 weeks of gestation)
3
Apnea Hypopnea Index (AHI)
Timeframe: Post partum (6-10 weeks after delivery)
4
Resting sympathetic activity
Timeframe: Early pregnancy (< 12 weeks gestation)
5
Resting sympathetic activity
Timeframe: Late pregnancy (30-34 weeks of gestation)
6
Resting sympathetic activity
Timeframe: Post partum (6-10 weeks after delivery)
7
Serum corin content measurement
Timeframe: Early pregnancy (< 12 weeks gestation)
8
Trial details
NCT IDNCT05654259
SponsorUniversity of Texas Southwestern Medical Center