The Association Between High Risk Pregnancy and Sleep-disordered Breathing

NCT01022619 | Unknown

• 1 other identifier: 61/09
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Preeclampsia; Gestational Diabetes; Premature Labor

Keywords

Sleep apnea; high risk pregnancy; fetal outcome; cord blood

Outcome Measures

Primary Outcomes (1)

• apnea-hypopnea index

  At time of assessment

Secondary Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Age 19 - 39 years
• Over 26 weeks of gestation
• One of the following:
• Pre-eclampsia defined as systolic blood pressure \> 140 or diastolic blood pressure \> 90 and associated proteinuria \> 300 mg / 24 h urine collection.
• Gestational diabetes requiring insulin treatment
• Premature contractions with associated cervical dilation or effacement
• Uncomplicated pregnancy

You may not qualify if:

• Chronic maternal disease
• Alcohol consumption during pregnancy
• Illicit drug abuse at any time in life
• Fetal abnormalities on obstetric ultrasound

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Meir Medical Center: collaborator

Study Sites (2)

Meir Hospital

Kfar Saba, 44281, Israel

Location

Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pre-Eclampsia; Diabetes, Gestational; Obstetric Labor, Premature; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor Complications; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Isaac Shpirer, MD

  Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Biron-Shental, MD

CONTACT

shentalt@inter.net.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

IL (2)