Clinical trial NCT01022619: The Association Between High Risk Pregnancy and Sleep-disordered Breathing
Official title: The Association Between High Risk Pregnancy and Sleep-disordered Breathing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Gestational Diabetes
Premature Labor
Keywords: Sleep apnea
high risk pregnancy
fetal outcome
cord blood
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Meir Medical Center
First posted: 2009-12-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: At time of assessment
Secondary outcomes:
measure: birth weight, apgar score
timeFrame: at birth
measure: inflammatory markers in cord blood
timeFrame: at birth
measure: growth and development during the 1st year of life
timeFrame: at age 1 year
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Hospital
city: Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
name: Isaac Shpirer, MD
role: PRINCIPAL_INVESTIGATOR
References: