Sleep Apnea and Fetal Growth Restriction

Phase 3

Terminated

• Conditions: Fetal Growth Restriction; Pregnancy Related; Obstructive Sleep Apnea
• Interventions: Device: S9 VPAP Adapt

• Registration Number: NCT04084990
• Lead Sponsor: Washington University School of Medicine

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 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).

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's breathing pauses or becomes shallow during sleep. These periods of low oxygen lead stress and inflammation which that may be harmful to both the mother and her fetus. OSA in pregnancy has been associated with poor maternal-fetal outcomes, including low birth weight, preterm delivery, FGR, gestational hypertension/preeclampsia, gestational diabetes and higher rates of neonatal ICU admission.

Auto-titrated positive airway pressure (aPAP) is a machine that gently delivers pressurized air via a mask to keep a patient's airways free of obstruction during sleep. It is currently unclear whether treatment of OSA during pregnancy in women with known FGR can improve fetal and neonatal outcomes.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-07
• Study First Submitted QC: 2019-09-07
• Study First Posted: 2019-09-11
• Study Start: 2019-11-18
• Primary Completion: 2021-07-27
• Study Completion: 2021-07-27
• Results First Submitted: 2022-01-19
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Results First Posted: 2022-03-09
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aPAP	S9 VPAP Adapt	Nightly use of aPAP when sleeping through the date of delivery

Primary Outcome Measures

Name	Time	Method
Birth Weight	1 day	Weight of child at time of birth

Secondary Outcome Measures

Name	Time	Method
Gestational Age at Delivery	1 day	Gestational age at delivery

Trial Locations

Locations (3)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Rochester University Medical Center; 🇺🇸 Rochester, New York, United States

Hadassah Hebrew University; 🇮🇱 W. Jerusalem, Jerusalem, Israel