Pregnancy, Sleep Disordered Breathing and Peripartum Complications
Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 11, 2016
November 1, 2015
1.8 years
November 25, 2015
January 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of Fetal Growth Restriction at Birth
expressed as a percentile of predicted weight
6 months
Secondary Outcomes (1)
Change in estimated fetal weight based on crossing nomograms
6 months
Study Arms (2)
Parturients with FGR/OSA who use CPAP
EXPERIMENTALSubjects 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).
Parturients with FGR/OSA and no CPAP
NO INTERVENTIONSubjects 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).
Interventions
FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.
Eligibility Criteria
You may qualify if:
- i. Prepartum
- years of age and older, able to provide informed consent
- Pregnant
- Diagnosis of fetal growth restriction (by ultrasound)
You may not qualify if:
- Patient refusal
- Inability to provide informed consent
- Known maternal severe cardiopulmonary disease
- Known fetal anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- University of Rochestercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yehuda Ginosar, M.D.
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
January 11, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
January 11, 2016
Record last verified: 2015-11