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
About this trial
This is an interventional treatment trial for Sleep Apnea
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
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
NCT ID
NCT02651649
First Posted
November 25, 2015
Last Updated
January 7, 2016
Sponsor
Hadassah Medical Organization
Collaborators
University of Rochester
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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