The Association Between High Risk Pregnancy and Sleep-disordered Breathing

• Conditions: Preeclampsia; Gestational Diabetes; Premature Labor

• Registration Number: NCT01022619
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2009-11
• Study First Submitted: 2009-11-26
• Study First Submitted QC: 2009-11-30
• Last Update Submitted: 2009-11-30
• Study First Posted: 2009-12-01
• Last Update Posted: 2009-12-01
• Study Start: 2010-01
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index	At time of assessment

Secondary Outcome Measures

Name	Time	Method
growth and development during the 1st year of life	at age 1 year
birth weight, apgar score	at birth
inflammatory markers in cord blood	at birth

Trial Locations

Locations (2)

Meir Hospital; 🇮🇱 Kfar-Saba, Israel

Asaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel