Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01585844 · ClinicalTrials.gov registry record

Sleep Apnea in Pregnancy Screening Study

A clinical trial, sponsored by MetroHealth Medical Center.

Completed
Registry status
182
Enrollment target

NCT01585844 is a clinical trial that has completed, run by MetroHealth Medical Center. The registered enrollment target is 182 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01585844 has completed, sponsored by MetroHealth Medical Center.

COMPLETED
Registry status
182 participants
Enrollment target

Study Summary

Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes. The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2008-08
Est. Completion 2012-04

Sponsor

MetroHealth Medical Center

76 total trials

What the Registry Record Tells You About NCT01585844

The ClinicalTrials.gov registry entry for NCT01585844 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01585844 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01585844 about?

NCT01585844 is a clinical study titled "Sleep Apnea in Pregnancy Screening Study". Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further informa...

What is the current status of trial NCT01585844?

This trial is currently completed. The enrollment target is 182 participants. The study started on 2008-08. Estimated completion is 2012-04.

Who is sponsoring clinical trial NCT01585844?

This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.