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| Name | Class |
|---|---|
| Meir Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| apnea-hypopnea index | At time of assessment |
| Measure | Description | Time Frame |
|---|---|---|
| birth weight, apgar score | at birth | |
| inflammatory markers in cord blood | at birth | |
| growth and development during the 1st year of life |
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Inclusion Criteria:
Age 19 - 39 years
Over 26 weeks of gestation
One of the following:
Exclusion Criteria:
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Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tal Biron-Shental, MD | Contact | shentalt@inter.net.il |
| Name | Affiliation | Role |
|---|---|---|
| Isaac Shpirer, MD | Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Hospital | Kfar Saba | 44281 | Israel |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| D007752 | Obstetric Labor, Premature |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Cord blood will be obtained in EDTA tubes and serum-seperating tubes
| at age 1 year |
| Asaf Harofeh Medical Center | Ẕerifin | 70300 | Israel |
|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007744 | Obstetric Labor Complications |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |