Pregnancy, Sleep Disordered Breathing and Peripartum Complications

NCT ID: NCT02651649

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-12-31

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.

Conditions

Sleep Apnea; Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parturients with FGR/OSA who use CPAP

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).

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type: DEVICE

FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.

Parturients with FGR/OSA and no CPAP

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Positive Airway Pressure (CPAP)

FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.

Intervention Type: DEVICE

Other Intervention Names

APAP, PAP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehuda Ginosar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Central Contacts

Yehuda Ginosar, M.D.

Role: CONTACT

yginosar@icloud.com

Suzanne Karan, M.D.

Role: CONTACT

suzanne_karan@urmc.rochester.edu

058-692-0334

Other Identifiers

0411/15/HMO

Identifier Type: -

Identifier Source: org_study_id