Pregnant Women Clinical Trial
Official title:
Fetal Outcome of Sleep Disordered Breathing During Pregnancy
Sleep disordered breathing (SDB) is a frequent disorder characterized by some combination of
repeated events of partial or complete upper airway obstruction during sleep, disruption of
normal ventilation, hypoxemia, and sleep fragmentation. When untreated, SDB is associated
with serious cardiovascular and neurobehavioral morbidities. Many physiologic changes that
occur during pregnancy may compromise the respiratory system and place women at risk for
developing SDB. Indeed, snoring has been reported in up to 46% of pregnant women.
Preliminary evidence suggests that SDB is associated with the hypertensive conditions of
pregnancy and that oxidative stress and endothelial dysfunction are mechanisms important in
the development of both conditions. Moreover, early reports in animals and in humans suggest
that maternal SDB may affect the developing fetus and that the intermittent hypoxia and
increased sympathetic activity induced by SDB could potentially contribute to adverse
maternal-fetal outcome. However, previous reports have focused on crude and non specific
measures of fetal outcome such as birth weight and APGAR (Appearance, Pulse, Grimace,
Activity, Respiration) score and currently there is no data on the mechanisms underlying the
adverse effect of maternal SDB on the fetus and the newborn infant.
Hypothesis: SDB during pregnancy imposes a risk to the developing fetus and the newborn
infant through mechanisms mediated by maternal hypoxia.
Objectives:
1. To prospectively investigate the incidence and severity of SDB during pregnancy using
an objective tool, i.e., overnight polysomnography (PSG) or at-home sleep study using
portable device in a large cohort of pregnant women.
2. To examine the effect of maternal SDB on fetal and neonatal outcome. Methods: 300 women
in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk
obstetric surveillance will be recruited. Hundred women hospitalized at the Antenatal
department due to pregnancy related hypertensive disorder, intrauterine growth
restriction (IUGR), diabetes mellitus or premature labor will also be recruited. In
addition, 200 women of a singleton uncomplicated pregnancy will be recruited during
labor at the delivery room. All participants will be asked to complete a designated
sleep questionnaire. Based on the questionnaires, women in the third trimester will
undergo a sleep study. Medical records review will be conducted after delivery and will
include information of maternal blood pressure, labor duration, route of delivery,
infant birth weight and APGAR score. Placentas will be collected immediately after
delivery from all women. Cord blood will be obtained immediately after delivery and
will be analyzed. Post-natal neurobehavioral evaluation will be conducted. Data
analysis will be performed on 4 population subgroups: (1) Sleep study proven SDB, (2)
Sleep study proven non-SDB, (3) SDB per questionnaire, (4) non-SDB per questionnaire.
Comparisons of fetal outcome measures according to group assignment will be performed.
In addition, the association between the severity of SDB based on sleep studies (degree
of hypoxemia, degree of sleep fragmentation, amount of respiratory events) and outcome
measures will be performed.
Sleep questionnaire: The questionnaire is based on validated questionnaires and includes
information on snoring, sleep pauses and daytime sleepiness.Completed questionnaires will be
reviewed weekly, and women with either severe daytime sleepiness or self reported frequent
snoring or any degree of sleep apnea will be contacted and be requested to undergo clinical
evaluation and an overnight polysomnography (estimated - 100 women). This evaluation will
consist of an in-depth sleep related and general medical history and physical examination
including body mass measurements (height, weight, neck circumference).
Tissue and umbilical cord blood collection: Placentas will be evaluated by a single
pathologist. The pathologist will be blind to the medical and perinatal history but not to
gestational age. Each placenta will be examined using a criteria previously reported.
Cord blood will be obtained at birth from the double clamped umbilical vein and will be
processed immediately for fetal blood gases analysis. Immediately following delivery, 5 mL
of blood will be obtained from the umbilical cord of all babies.
Neuro-behavioral evaluation of the newborn will be conducted at the first 48 hours of life.
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Observational Model: Cohort, Time Perspective: Prospective
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