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
  Purpose

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
Preeclampsia
Gestational Diabetes
Premature Labor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Association Between High Risk Pregnancy and Sleep-disordered Breathing

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • apnea-hypopnea index [ Time Frame: At time of assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders 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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022619

Contacts
Contact: Tal Biron-Shental, MD shentalt@inter.net.il

Locations
Israel
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
Investigators
Principal Investigator: Isaac Shpirer, MD Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Isaac Shpirer, MD, head of the sleep laboratory, Asaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01022619     History of Changes
Other Study ID Numbers: 61/09
Study First Received: November 26, 2009
Last Updated: November 30, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Diabetes, Gestational
Obstetric Labor, Premature
Pre-Eclampsia
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hypertension, Pregnancy-Induced
Metabolic Diseases
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 23, 2014