Pregnancy, Sleep Disordered Breathing and Peripartum Complications

Pregnancy Clinical Trial

Official title:

Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02651649
• Other study ID #: 0411/15/HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2015
• Last updated: January 7, 2016
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: Hadassah Medical Organization
• Contact: Yehuda Ginosar, M.D.
• Email: yginosar[@]icloud.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Sleep Apnea

Intervention

Device:
• Continuous Positive Airway Pressure (CPAP)
FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Fetal Growth Restriction at Birth	expressed as a percentile of predicted weight	6 months	No
Secondary	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	6 months	No