Fetal Growth Restriction, Obstructive Sleep Apnea, Pregnancy Related
Conditions
Keywords
aPAP, OSA, FGR
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.
Interventions
DEVICES9 VPAP Adapt
Auto-titrated positive airway pressure
Sponsors
ResMed Foundation
Hebrew University Hadassah Medical School
University of Rochester
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, parallel group, investigator-blinded, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | 1 day | Weight of child at time of birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Age at Delivery | 1 day | Gestational age at delivery |
Countries
Israel, United States
Participant flow
Recruitment details
The study has been terminated due to low enrollment after only 3 participants were randomized. Results will not be analyzed owing to the small number of participants to be randomized to receive aPAP (the intervention) or no aPAP (standard of care treatment).
Pre-assignment details
32 participants provided informed consent to participate. They underwent an obstructive sleep apnea (OSA) risk assessment questionnaire. Those screening as high risk for OSA underwent home sleep apnea testing (HSAT). Those screening as positive on the HSAT, which was defined as an apnea hypopnea index (AHI) \>= 10 OR an AHI \>= 5 with oxygen desaturation index \>= 5, were randomized to receive aPAP or not. Of the 32 participants, only 3 met criteria for enrollment in the randomization phase.
Participants by arm
| Arm | Count |
|---|---|
| aPAP Nightly use of aPAP when sleeping through the date of delivery
S9 VPAP Adapt: Auto-titrated positive airway pressure | 2 |
| No aPAP No use of aPAP (standard of care) | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | aPAP | No aPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 32.8 Years | 29.8 Years | 31.8 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Birth Weight
Weight of child at time of birth
Time frame: 1 day
Population: Of two mothers randomized to aPAP therapy, one required pre-term induction of labor for maternal safety for preeclampsia with severe features. This fetus experienced in-utero fetal demise, so birth weight was not obtained.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| aPAP | Birth Weight | 2320 grams |
| No aPAP | Birth Weight | 570 grams |
Secondary
Gestational Age at Delivery
Gestational age at delivery
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| aPAP | Gestational Age at Delivery | 31.4 weeks (estimated gestational age) |
| No aPAP | Gestational Age at Delivery | 25.7 weeks (estimated gestational age) |