Sleep Apnea and Fetal Growth Restriction

Obstructive Sleep Apnea Clinical Trial

— SAFER  

Official title:

Sleep Apnea and Fetal Growth Restriction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04084990
• Other study ID #: 201908162
• Status: Terminated
• Phase: Phase 3
• Start date: November 18, 2019
• Est. completion date: July 27, 2021

Study information

• Verified date: March 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Fetal Growth Restriction
• Fetal Growth Retardation
• Obstructive Sleep Apnea
• Pregnancy Related
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• S9 VPAP Adapt
Auto-titrated positive airway pressure

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University	W. Jerusalem	Jerusalem
United States	Rochester University Medical Center	Rochester	New York
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	ResMed Foundation, The Hebrew University Hadassah Medical School, University of Rochester

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (2)

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. Review. — View Citation

Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marçal VM, Lobo TF, Peixoto AB, Araujo Júnior 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Weight	Weight of child at time of birth	1 day
Secondary	Gestational Age at Delivery	Gestational age at delivery	1 day