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The Association Between High Risk Pregnancy and Sleep-disordered Breathing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Meir Medical Center
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01022619
First received: November 26, 2009
Last updated: November 30, 2009
Last verified: November 2009

November 26, 2009
November 30, 2009
January 2010
January 2012   (final data collection date for primary outcome measure)
apnea-hypopnea index [ Time Frame: At time of assessment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01022619 on ClinicalTrials.gov Archive Site
  • birth weight, apgar score [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • inflammatory markers in cord blood [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • growth and development during the 1st year of life [ Time Frame: at age 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Association Between High Risk Pregnancy and Sleep-disordered Breathing
The Association Between High Risk Pregnancy and Sleep-disordered Breathing

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cord blood will be obtained in EDTA tubes and serum-seperating tubes

Probability Sample

Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course

  • Preeclampsia
  • Gestational Diabetes
  • Premature Labor
Not Provided
  • Premature labor
    Women at the third trimester of pregnancy with premature contractions and cervical dilation of effacement
  • Control
    Women at the third trimester of pregnancy with uncomplicated pregnancy
  • Pre-eclampsia
    Women at the third trimester with pre-eclampsia
  • Gestational diabets
    Women at the third trimester of pregnancy with gestational diabetes requiring insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Female
19 Years to 39 Years
Yes
Contact: Tal Biron-Shental, MD shentalt@inter.net.il
Israel
 
NCT01022619
61/09
No
Isaac Shpirer, MD, head of the sleep laboratory, Asaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Meir Medical Center
Principal Investigator: Isaac Shpirer, MD Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
Assaf-Harofeh Medical Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP