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Pregnancy, Sleep Disordered Breathing and Peripartum Complications

Primary Purpose

Sleep Apnea, Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • i. Prepartum

    • 18 years of age and older, able to provide informed consent
    • Pregnant
    • Diagnosis of fetal growth restriction (by ultrasound)

Exclusion Criteria:

  • • Patient refusal

    • Inability to provide informed consent
    • Known maternal severe cardiopulmonary disease
    • Known fetal anomalies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Parturients with FGR/OSA who use CPAP

    Parturients with FGR/OSA and no CPAP

    Arm Description

    Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for Continuous Positive Airway Pressure (CPAP). Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).

    Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for CPAP. Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).

    Outcomes

    Primary Outcome Measures

    Presence of Fetal Growth Restriction at Birth
    expressed as a percentile of predicted weight

    Secondary Outcome Measures

    Change in estimated fetal weight based on crossing nomograms
    estimated growth of fetus by gestational age will be plotted and compared to group who did not receive CPAP

    Full Information

    First Posted
    November 25, 2015
    Last Updated
    January 7, 2016
    Sponsor
    Hadassah Medical Organization
    Collaborators
    University of Rochester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02651649
    Brief Title
    Pregnancy, Sleep Disordered Breathing and Peripartum Complications
    Official Title
    Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization
    Collaborators
    University of Rochester

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor maternal and fetal outcomes. The investigators propose a prospective observational study to assess the utility of continuous positive airway pressure (CPAP) administration (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing as measured by ambulatory sleep monitoring applied in the hospital setting.
    Detailed Description
    Hypothesis: CPAP application in SDB-diagnosed parturients will decrease fetal and maternal morbidity. Specific Aims: 1. To screen women after their first trimester of pregnancy that are at risk for carrying babies with fetal growth restriction (FGR) for presence of SDB (FGR is commonly diagnosed at 20 weeks gestation by ultrasound as standard of care) and to follow their diagnosis and treatment with CPAP, as per standard of care, for the remainder of their pregnancy or order to follow fetal and maternal outcomes. a. Screen = parturients affirm presence of snoring. b. Screen positive parturients are further assessed with 1-2 nights of ambulatory sleep and respiration monitor to confirm SDB b. SDB positive parturients are offered treatment, as per standard of care, with CPAP. c. Screen positive parturients are reassessed with 1-2 nights of ambulatory sleep monitoring (whether or not CPAP is eventually applied) at two more intervals during pregnancy (during second and third trimesters), and then 6-8 weeks after delivery. This study is designed as a prospective observational cohort study in order establish the concurrence of the disease (SDB) as it occurs with the increased "risk" or exposure to the vulnerable state (pregnancy) and presence of diagnosed fetal growth restriction. In addition, parturients who test positive for SDB will be assessed by a pulmonologist and offered standard of care therapy with CPAP, as appropriate. CPAP use will then be followed and assessed as a mitigating intervention to blunt fetal growth restriction. This study is a pilot in that we hope to establish the incidence of co-morbidities in order to appropriately plan for an adequate sample size in future intervention studies. Given the large overall parturient population that will be available to the study team, we believe that in one calendar year we will observe sufficient patients to establish the relationship of SDB during the antenatal pregnancy and fetal growth restriction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea, Pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Parturients with FGR/OSA who use CPAP
    Arm Type
    Experimental
    Arm Description
    Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for Continuous Positive Airway Pressure (CPAP). Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).
    Arm Title
    Parturients with FGR/OSA and no CPAP
    Arm Type
    No Intervention
    Arm Description
    Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for CPAP. Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).
    Intervention Type
    Device
    Intervention Name(s)
    Continuous Positive Airway Pressure (CPAP)
    Other Intervention Name(s)
    APAP, PAP
    Intervention Description
    FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.
    Primary Outcome Measure Information:
    Title
    Presence of Fetal Growth Restriction at Birth
    Description
    expressed as a percentile of predicted weight
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in estimated fetal weight based on crossing nomograms
    Description
    estimated growth of fetus by gestational age will be plotted and compared to group who did not receive CPAP
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: i. Prepartum 18 years of age and older, able to provide informed consent Pregnant Diagnosis of fetal growth restriction (by ultrasound) Exclusion Criteria: • Patient refusal Inability to provide informed consent Known maternal severe cardiopulmonary disease Known fetal anomalies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yehuda Ginosar, M.D.
    Email
    yginosar@icloud.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne Karan, M.D.
    Phone
    058-692-0334
    Email
    suzanne_karan@urmc.rochester.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yehuda Ginosar, M.D.
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pregnancy, Sleep Disordered Breathing and Peripartum Complications

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