N/A
N=89
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Obese · Pregnancy · Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT02086448 ↗Enrolled (actual)
89
Serious AEs
2.3%
Results posted
Mar 2022
Primary outcome: Primary: Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound — 1.0; 1.0; 1.0; 1.0 Mean PI
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP (Device); sham-CPAP (Device); Sleep hygiene (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Francesca Facco, MD
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound |
0.9; 0.8; 0.8; 0.7 | — |
| PRIMARY Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement |
30.5; 26.0; 38.3; 45.9 | — |
| PRIMARY Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin |
6.3; 3.7; 3.6; 4.6 | — |
| PRIMARY Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound |
0.9; 0.8; 0.8; 0.7 | — |
| PRIMARY Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement |
30.5; 26.0; 38.3; 45.9 | — |
| PRIMARY Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin |
6.3; 3.7; 3.6; 4.6 | — |
| SECONDARY Placental Histology and Immunohistochemistry |
— | — |
Summary
The purpose of this study is to better understand how sleep apnea, a common sleep disorder in which a person has one or more pauses in breathing or shallow breaths while sleeping, may affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant women with sleep apnea.
Eligibility Criteria
Inclusion Criteria
- women between 14 0/7 and 20 6/7 weeks gestation at the time of their initial PSG assessment.
- Pregnancy and current BMI >=30
- Self-reported frequent snoring (>=3x/week over past month) or self-reported non-snorer.
Exclusion Criteria
- diagnosis of pregestational diabetes.
- self-report a history of sleep apena and who are using or were receommended by a physican to use a PAP device already
- twins
Data sourced from ClinicalTrials.gov (NCT02086448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.