The Association Between High Risk Pregnancy and Sleep-disordered Breathing

Official Title: “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.

Arms, Groups and Cohorts in this Clinical Trial

• : 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

Primary Measures

• apnea-hypopnea index
  • Time Frame: At time of assessment
    Safety Issue?: No

Secondary Measures

• birth weight, apgar score
  • Time Frame: at birth
    Safety Issue?: No
• inflammatory markers in cord blood
  • Time Frame: at birth
    Safety Issue?: No
• growth and development during the 1st year of life
  • Time Frame: at age 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Assaf-Harofeh Medical Center Other

Overall Clinical Trial Officials and Contacts

Isaac Shpirer, MD Principal Investigator Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center  

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01022619

Study ID Number: 61/09

ClinicalTrials.gov Identifier: NCT01022619

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration