Working... Menu

The Association Between High Risk Pregnancy and Sleep-disordered Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022619
Recruitment Status : Unknown
Verified November 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Meir Medical Center
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
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.

Condition or disease
Preeclampsia Gestational Diabetes Premature Labor

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Association Between High Risk Pregnancy and Sleep-disordered Breathing
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

Premature labor
Women at the third trimester of pregnancy with premature contractions and cervical dilation of effacement
Women at the third trimester of pregnancy with uncomplicated pregnancy
Women at the third trimester with pre-eclampsia
Gestational diabets
Women at the third trimester of pregnancy with gestational diabetes requiring insulin

Primary Outcome Measures :
  1. apnea-hypopnea index [ Time Frame: At time of assessment ]

Secondary Outcome Measures :
  1. birth weight, apgar score [ Time Frame: at birth ]
  2. inflammatory markers in cord blood [ Time Frame: at birth ]
  3. growth and development during the 1st year of life [ Time Frame: at age 1 year ]

Biospecimen Retention:   Samples With DNA
Cord blood will be obtained in EDTA tubes and serum-seperating tubes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022619

Layout table for location contacts
Contact: Tal Biron-Shental, MD

Layout table for location information
Meir Hospital Not yet recruiting
Kfar-Saba, Israel, 44281
Contact: Tal Biron Shental, MD         
Sub-Investigator: Tal Biron-Shental, MD         
Asaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Arnon Elizur, MD         
Sub-Investigator: Arnon Elizur, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Meir Medical Center
Layout table for investigator information
Principal Investigator: Isaac Shpirer, MD Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center

Layout table for additonal information
Responsible Party: Isaac Shpirer, MD, head of the sleep laboratory, Asaf Harofeh Medical Center Identifier: NCT01022619     History of Changes
Other Study ID Numbers: 61/09
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by Assaf-Harofeh Medical Center:
Sleep apnea
high risk pregnancy
fetal outcome
cord blood

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Diabetes, Gestational
Obstetric Labor, Premature
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypertension, Pregnancy-Induced
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Obstetric Labor Complications