Status:
TERMINATED
Sleep Apnea and Fetal Growth Restriction
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
ResMed Foundation
Hebrew University Hadassah Medical School
Conditions:
Obstructive Sleep Apnea
Fetal Growth Restriction
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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 antenata...
Detailed Description
Fetal growth restriction (FGR) affects 5-10% of pregnancies and is one of the leading causes of perinatal morbidity and mortality. Obstructive sleep apnea (OSA) is a common disorder in which a person...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04084990
Start Date
November 18 2019
End Date
July 27 2021
Last Update
March 9 2022
Active Locations (3)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110
2
Rochester University Medical Center
Rochester, New York, United States, 14620
3
Hadassah Hebrew University
West Jerusalem, Jerusalem, Israel, 9112001