TerminatedPhase 3

Sleep Apnea and Fetal Growth Restriction

Stopped: The study was terminated due to insufficient recruitment.

United States, Israel3 participantsStarted 2019-11-18

Plain-language summary

This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor. Of those patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and half will not (standard care).

Who can participate

Age range

18 Years – 50 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: * Age ≥ 18 and ≤ 50 * Fetal growth restriction (defined as fetal weight \<10th percentile based on at least one routine 2nd trimester ultrasound without a subsequent increase to \>15th percentile on any ultrasounds prior to enrollment) * Lower limit of gestational age at enrollment 22+0 weeks. * Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2 and if appropriate to be randomized and receive intervention by no later than 32+0 weeks. * The absence of 2 minor or 1 major markers of aneuploidy. Exclusion Criteria: * Other known cause of fetal growth restriction (including congenital anomalies, intrauterine infection, or multiple gestation) * Reversed end-diastolic flow in the umbilical artery * Preexisting diagnosis of OSA being treated with aPAP * Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma) * Hemoglobinopathies (sickle cell anemia, thalassemia) * Maternal craniofacial anomalies * Premature rupture of membranes

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

Birth Weight

Timeframe: 1 day

Trial details

NCT IDNCT04084990

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-27

Results submitted2022-01-19

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials