Clinical trial NCT04084990: Sleep Apnea and Fetal Growth Restriction
Official title: Sleep Apnea and Fetal Growth Restriction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Fetal Growth Restriction
Pregnancy Related
Keywords: aPAP
OSA
FGR
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: ResMed Foundation
name: Hebrew University Hadassah Medical School
name: University of Rochester
First posted: 2019-09-11
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel group, investigator-blinded, randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Birth Weight
timeFrame: 1 day
Secondary outcomes:
measure: Gestational Age at Delivery
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Rochester
country: United States
facility: Rochester University Medical Center
state: New York
city: W. Jerusalem
country: Israel
facility: Hadassah Hebrew University
state: Jerusalem
Study officials:
affiliation: Washington University in Saint Louis
name: Alexander Hincker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11.
citation: Lavie L. Oxidative stress in obstructive sleep apnea and intermittent hypoxia--revisited--the bad ugly and good: implications to the heart and brain. Sleep Med Rev. 2015 Apr;20:27-45. doi: 10.1016/j.smrv.2014.07.003. Epub 2014 Jul 24.
citation: Hincker A, Nadler J, Karan S, Carter E, Porat S, Warner B, Ju YS, Ben Abdallah A, Wilson E, Lockhart EM, Ginosar Y. Sleep Apnea and Fetal Growth Restriction (SAFER) study: protocol for a pragmatic randomised clinical trial of positive airway pressure as an antenatal therapy for fetal growth restriction in maternal obstructive sleep apnoea. BMJ Open. 2021 Jun 29;11(6):e049120. doi: 10.1136/bmjopen-2021-049120.