Sleep Apnea and Fetal Growth Restriction

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-07-27

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Fetal Growth Restriction Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel group, investigator-blinded, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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aPAP

Nightly use of aPAP when sleeping through the date of delivery

Group Type EXPERIMENTAL

S9 VPAP Adapt

Intervention Type DEVICE

Auto-titrated positive airway pressure

No aPAP

No use of aPAP (standard of care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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S9 VPAP Adapt

Auto-titrated positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No