The Association Between High Risk Pregnancy and Sleep-disordered Breathing

Gestational Diabetes Clinical Trial

Official title:

The Association Between High Risk Pregnancy and Sleep-disordered Breathing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01022619
• Other study ID #: 61/09
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2009
• Last updated: November 30, 2009
• Start date: January 2010

Study information

• Verified date: November 2009
• Source: Assaf-Harofeh Medical Center
• Contact: Tal Biron-Shental, MD
• Email: shentalt[@]inter.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Obstetric Labor, Premature
• Preeclampsia
• Premature Labor

Locations

Country	Name	City	State
Israel	Meir Hospital	Kfar-Saba
Israel	Asaf Harofeh Medical Center	Zerifin

Sponsors (2)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index		At time of assessment	No
Secondary	birth weight, apgar score		at birth	No
Secondary	inflammatory markers in cord blood		at birth	No
Secondary	growth and development during the 1st year of life		at age 1 year	No