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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 : August 22, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obese Pregnancy Sleep Disordered Breathing Device: CPAP Device: sham-CPAP Other: Sleep hygiene

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2019
Arms and Interventions

Arm Intervention/treatment
No Intervention: Obese, SDB negative
No intervention, observational comparison group
Active Comparator: Obese, SDB postive, CPAP
Therapeutic CPAP
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
Sham Comparator: Obese, SDB postive, sham-CPAP
Sham (non-therapeutic) CPAP
Device: sham-CPAP
Obese, SDB postive, sleep hygiene
Sleep hygiene information and local sleep resources
Other: Sleep hygiene
Information about sleep apnea and healthy sleep. Information about local sleep resources

Outcome Measures

Primary Outcome Measures :
  1. Uterine artery Doppler mean pulsatility index -by ultrasound [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  2. sFLT/PIGF ratio-blood measurement [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  3. Homeostasis model assessment of insulin resistance (HOMA-IR)-blood measurement of glucose and insulin [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  4. Uterine artery Doppler mean pulsatility index -by ultrasound [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  5. sFLT/PIGF ratio-blood measurement [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  6. Homeostasis model assessment of insulin resistance (HOMA-IR)-blood measurement of glucose and insulin [ Time Frame: late pregnancy (28-32 weeks gestation) ]

Secondary Outcome Measures :
  1. placental histology and immunohistochemistry [ Time Frame: After delivery (expected 37-40 weeks gestation) ]

Other Outcome Measures:
  1. Mean arterial blood pressure (mmHg) Angiogenic Domain [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  2. 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

  3. Mean arterial blood pressure (mmHg) Angiogenic Domain [ Time Frame: late pregnancy (28-32 weeks gestation) ]
  4. sEng (pg/mL)-blood measurement [ Time Frame: early pregnancy (14-16 weeks gestation) ]
  5. sEng (pg/mL)-blood measurement [ Time Frame: late pregnancy (28-32 weeks gestation) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086448

Contact: Francesca Facco, MD 412-641-5406 faccof@upmc.ed

United States, Pennsylvania
Magee-Womens Hospital of the UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Francesca Facco, MD University of Pittsburgh
More Information

Responsible Party: Francesca Facco, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02086448     History of Changes
Other Study ID Numbers: PRO13080159
R01HL120354 ( U.S. NIH Grant/Contract )
K12HD043441 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes