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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Kfar-Saba, Israel, 44281
    • Meir Hospital
  • Zerifin, Israel, 70300
    • Asaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
apnea-hypopnea index	At time of assessment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Meir Medical Center
• Investigators: Principal Investigator: Isaac Shpirer, MD, Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 1, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: cord blood; fetal outcome; high risk pregnancy; Sleep apnea
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Obstetric Labor Complications; Hypertension, Pregnancy-Induced; Sleep Apnea Syndromes; Pre-Eclampsia; Obstetric Labor, Premature; Diabetes, Gestational
• Other Study ID Numbers: 61/09