Pregnancy Clinical Trial
— SOAPOfficial title:
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Verified date | February 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | February 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Magee-Womens Hospital of the UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Francesca Facco, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Arterial Blood Pressure (mmHg) Angiogenic Domain | early pregnancy (14-16 weeks gestation) | ||
Other | Pregnancy Outcome Data | Preeclampsia, Gestational diabetes, Gestational age at delivery, Indication for delivery, Birthweight, Cord gases | At time of delivery (expected 37-40 weeks gestation) | |
Other | Mean Arterial Blood Pressure (mmHg) Angiogenic Domain | late pregnancy (28-32 weeks gestation) | ||
Other | Soluble Endoglin (sEng ,pg/mL)-Blood Measurement | Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts | early pregnancy (14-16 weeks gestation) | |
Other | Soluble Endoglin (sEng , pg/mL)-Blood Measurement | Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts | late pregnancy (28-32 weeks gestation) | |
Primary | Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound | The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of <30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity. | early pregnancy (14-16 weeks gestation) | |
Primary | Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement | sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia. | early pregnancy (14-16 weeks gestation) | |
Primary | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin | Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5) | early pregnancy (14-16 weeks gestation) | |
Primary | Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound | The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of <30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity. | late pregnancy (28-32 weeks gestation) | |
Primary | Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement | sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia. | late pregnancy (28-32 weeks gestation) | |
Primary | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin | Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5) | late pregnancy (28-32 weeks gestation) | |
Secondary | Placental Histology and Immunohistochemistry | placental histology and immunohistochemistry | After delivery (expected 37-40 weeks gestation) |
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