The Association Between High Risk Pregnancy and Sleep-disordered Breathing
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition |
|---|
|
Preeclampsia Gestational Diabetes Premature Labor |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Association Between High Risk Pregnancy and Sleep-disordered Breathing |
- apnea-hypopnea index [ Time Frame: At time of assessment ] [ Designated as safety issue: No ]
- birth weight, apgar score [ Time Frame: at birth ] [ Designated as safety issue: No ]
- inflammatory markers in cord blood [ Time Frame: at birth ] [ Designated as safety issue: No ]
- growth and development during the 1st year of life [ Time Frame: at age 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Cord blood will be obtained in EDTA tubes and serum-seperating tubes
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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Gestational diabets
Women at the third trimester of pregnancy with gestational diabetes requiring insulin
|
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| Ages Eligible for Study: | 19 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course
Inclusion Criteria:
- 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
Exclusion Criteria:
- Chronic maternal disease
- Alcohol consumption during pregnancy
- Illicit drug abuse at any time in life
- Fetal abnormalities on obstetric ultrasound
Contacts and Locations| Contact: Tal Biron-Shental, MD | shentalt@inter.net.il |
| Israel | |
| Meir Hospital | Not yet recruiting |
| Kfar-Saba, Israel, 44281 | |
| Contact: Tal Biron Shental, MD | |
| Sub-Investigator: Tal Biron-Shental, MD | |
| Asaf Harofeh Medical Center | Not yet recruiting |
| Zerifin, Israel, 70300 | |
| Contact: Arnon Elizur, MD | |
| Sub-Investigator: Arnon Elizur, MD | |
| Principal Investigator: | Isaac Shpirer, MD | Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center |
More Information
No publications provided
| Responsible Party: | Isaac Shpirer, MD, head of the sleep laboratory, Asaf Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT01022619 History of Changes |
| Other Study ID Numbers: | 61/09 |
| Study First Received: | November 26, 2009 |
| Last Updated: | November 30, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Assaf-Harofeh Medical Center:
|
Sleep apnea high risk pregnancy fetal outcome cord blood |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Obstetric Labor Complications Pre-Eclampsia Sleep Apnea Syndromes Diabetes, Gestational Pregnancy Complications Hypertension, Pregnancy-Induced Apnea Respiration Disorders |
Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013