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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: Completed study, sponsored by MetroHealth Medical Center.

NCT01585844 is a clinical trial that has completed, run by MetroHealth Medical Center. The registered enrollment target is 182 participants. According to ClinicalTrials.gov, the official US trial registry.

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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
MetroHealth Medical Center

76 total trials

What the finished NCT01585844 record still lists

NCT01585844 is an observational study that tracks outcomes without assigning an intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap.

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

NCT01585844 does not publish any study locations in the registry export this page uses.

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.

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Source: ClinicalTrials.gov NCT01585844, the US trial registry maintained by the National Library of Medicine. NCT01585844 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.