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The Association Between High Risk Pregnancy and Sleep-disordered Breathing

NCT ID: NCT01022619

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Brief Summary

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The aim of the present study is to establish, using polysomnographic criteria and prospective nature, whether sleep apnea in pregnancy is more prevalent in women with high risk pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with high risk pregnancy compared to those with uncomplicated pregnancy.

Detailed Description

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Over the last decade, the association between sleep disordered breathing and pregnancy outcome has been described primarily in case reports. Although recently, larger studies describing adverse pregnancy outcomes in women with sleep disordered breathing has begun to emerge, these studies often lack polysomnographic data and the true prevalence of sleep disordered breathing in pregnancy is not known. We intend to recruit 100 women at the third trimester of pregnancy, who are admitted to the high risk pregnancy unit with pre-eclampsia, gestational diabetes, or premature labor. An additional group of 50 women at the third trimester of an uncomplicated pregnancy will be recruited. All women will fill questionnaires regarding the pregnancy and their sleep and will undergo an overnight sleep study. Women will then be followed until birth. Pregnancy complication, birth and perinatal course will be recorded. Cord blood will be collected from all infants and evaluated for inflammatory cytokines, reactive oxygen species and growth factors. Infants will then be followed for 1 year. Their growth, development and intercurrent illnesses will be recorded.

Conditions

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Preeclampsia Gestational Diabetes Premature Labor

Keywords

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Sleep apnea high risk pregnancy fetal outcome cord blood

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature labor

Women at the third trimester of pregnancy with premature contractions and cervical dilation of effacement

No interventions assigned to this group

Control

Women at the third trimester of pregnancy with uncomplicated pregnancy

No interventions assigned to this group

Pre-eclampsia

Women at the third trimester with pre-eclampsia

No interventions assigned to this group

Gestational diabets

Women at the third trimester of pregnancy with gestational diabetes requiring insulin

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 19 - 39 years
* Over 26 weeks of gestation
* One of the following:

1. Pre-eclampsia defined as systolic blood pressure \> 140 or diastolic blood pressure \> 90 and associated proteinuria \> 300 mg / 24 h urine collection.
2. Gestational diabetes requiring insulin treatment
3. Premature contractions with associated cervical dilation or effacement
4. Uncomplicated pregnancy

Exclusion Criteria

* Chronic maternal disease
* Alcohol consumption during pregnancy
* Illicit drug abuse at any time in life
* Fetal abnormalities on obstetric ultrasound
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Asaf Harofeh Medical Center

Principal Investigators

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Isaac Shpirer, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center

Locations

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Meir Hospital

Kfar Saba, , Israel

Site Status

Asaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Tal Biron-Shental, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Tal Biron Shental, MD

Role: primary

Arnon Elizur, MD

Role: primary

Other Identifiers

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61/09

Identifier Type: -

Identifier Source: org_study_id