Sleep Apnea and Fetal Growth Restriction

Stopped early · Phase 3

Conditions studied: Obstructive Sleep Apnea, Fetal Growth Restriction, Pregnancy Related

In brief

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).

Key facts

Study ID

NCT04084990

Run by

Washington University School of Medicine

People needed

3

Starts

2019-11-18

Expected to finish

2021-07-27

Last updated by the study team

2022-03-09

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States
• Rochester University Medical Center — Rochester, New York, United States
• Hadassah Hebrew University — West Jerusalem, Jerusalem, Israel

Full record on ClinicalTrials.gov

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