N/A
Completed N=89
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Obese · Pregnancy · sleep-disordered breathing
Source: ClinicalTrials.gov NCT02086448 ↗
Enrolled (actual)
89
Serious AEs
2.3%
Results posted
Mar 2022
Primary outcomePrimary: Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound — 1.0; 1.0; 1.0; 1.0 Mean PI
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.
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 | — |
| SECONDARY Placental Histology and Immunohistochemistry |
— | — |
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. Informational only — not medical advice.