Sleep Apnea and Fetal Growth Restriction (SAFER)

The Washington University

Status and phase: Terminated; Phase 3

Conditions: Fetal Growth Restriction; Pregnancy Related; Obstructive Sleep Apnea

Treatments: Device: S9 VPAP Adapt

Study type: Interventional

Funder types: Other

Identifiers

NCT04084990

201908162

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

3 participants in 2 patient groups

aPAP

Experimental group

Description:

Nightly use of aPAP when sleeping through the date of delivery

Treatment:

Device: S9 VPAP Adapt

No aPAP

No Intervention group

Description:

No use of aPAP (standard of care)