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Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) (SOAP)

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ClinicalTrials.gov Identifier: NCT02086448
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Francesca Facco, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE March 13, 2014
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
  • Uterine artery Doppler mean pulsatility index -by ultrasound [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  • sFLT/PIGF ratio-blood measurement [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  • Homeostasis model assessment of insulin resistance (HOMA-IR)-blood measurement of glucose and insulin [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  • Uterine artery Doppler mean pulsatility index -by ultrasound [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  • sFLT/PIGF ratio-blood measurement [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  • Homeostasis model assessment of insulin resistance (HOMA-IR)-blood measurement of glucose and insulin [ Time Frame: late pregnancy (28-32 weeks gestation) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02086448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
placental histology and immunohistochemistry [ Time Frame: After delivery (expected 37-40 weeks gestation) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 11, 2014)
  • Mean arterial blood pressure (mmHg) Angiogenic Domain [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  • Pregnancy outcome data [ Time Frame: At time of delivery (expected 37-40 weeks gestation) ]
    Preeclampsia, Gestational diabetes, Gestational age at delivery, Indication for delivery, Birthweight, Cord gases
  • Mean arterial blood pressure (mmHg) Angiogenic Domain [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  • sEng (pg/mL)-blood measurement [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  • sEng (pg/mL)-blood measurement [ Time Frame: late pregnancy (28-32 weeks gestation) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Official Title  ICMJE Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Brief 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.
Detailed Description

Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes, particularly preeclampsia. Furthermore, SDB, which is characterized by intermittent nocturnal hypoxia-reoxygenation as well as sleep disruption, results in endothelial dysfunction and metabolic dysregulation, the same biological pathways that have been associated with adverse pregnancy outcomes. Obesity is a well-known risk factor for both adverse pregnancy outcomes and SDB, and has been associated with the same aforementioned biological aberrations. Therefore, obesity complicates the definition of a causal relationship between SDB and pregnancy outcomes. While some classic cardiovascular risk factors (prehypertension) are certainly relevant in pregnancy, there are also well-established risk factors that are unique to pregnancy (uterine vascular stiffness, placental angiogenic factors). The interplay between SDB, obesity and these unique cardiovascular risk factors remains undefined, and this proposal aims to address this knowledge gap. Without this data, our ability to understand how we can mitigate these risks through the use of therapeutic interventions for SDB, such as CPAP (continuous positive airway pressure), is compromised. To further address this knowledge gap, we will make use of the placenta's ability to accumulate evidence of damage over time and provide a record of maternal vascular health throughout gestation. Numerous placental lesions deriving from maternal vascular disease have been identified and can be readily detected on placental pathology. These lesions can provide a measure of the severity of hypoxic stress experienced by the fetus during gestation.

The investigators' central hypothesis is that SDB is an effect modifier that increases maternal cardiovascular risk and placental hypoxic injury in obese pregnant women, and that CPAP treatment during pregnancy will result in an improved cardiovascular risk and placental profile. To test this hypothesis the investigaotrs will identify a cohort of obese women both with and without SDB. The investigators will examine SDB's impact on maternal vascular stiffness (uterine artery Doppler), angiogenesis (pregnancy specific angiogenic factors e.g., sFLT-1) and metabolism (insulin resistance) across pregnancy (Aim 1). The investigators will perform a randomized controlled trial of autotitrating- CPAP verses sham-CPAP in pregnancy to examine the impact of CPAP treatment during pregnancy on cardiovascular risk (Aim 2) and will explore the interplay between SDB, CPAP and evidence of maternal vascular disease and chronic fetal hypoxia by evaluating the placental profile of obese women with and without SDB (Aim 3).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obese
  • Pregnancy
  • Sleep Disordered Breathing
Intervention  ICMJE
  • Device: CPAP
    CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
    Other Name: Continuous Positive Airway Pressure
  • Device: sham-CPAP
  • Other: Sleep hygiene
    Information about sleep apnea and healthy sleep. Information about local sleep resources
Study Arms  ICMJE
  • No Intervention: Obese, SDB negative
    No intervention, observational comparison group
  • Active Comparator: Obese, SDB postive, CPAP
    Therapeutic CPAP
    Intervention: Device: CPAP
  • Sham Comparator: Obese, SDB postive, sham-CPAP
    Sham (non-therapeutic) CPAP
    Intervention: Device: sham-CPAP
  • Obese, SDB postive, sleep hygiene
    Sleep hygiene information and local sleep resources
    Intervention: Other: Sleep hygiene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2015)
300
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2014)
16
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Francesca Facco, MD 412-641-5406 faccof@upmc.ed
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086448
Other Study ID Numbers  ICMJE PRO13080159
R01HL120354 ( U.S. NIH Grant/Contract )
K12HD043441 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesca Facco, MD, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Francesca Facco, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP