Fetal Outcome of Sleep Disordered Breathing During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Israel Science Foundation
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00931099
First received: July 1, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.

Condition
Pregnant Women

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Outcome of Sleep Disordered Breathing During Pregnancy

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • neonatal neurobehavioral measures [ Time Frame: first 48 h of life, age of 11 weeks and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Low risk pregnant women
300 women in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk obstetric surveillance
High risk pregnant women
100 women hospitalized at the Antenatal department due to pregnancy related hypertensive disorder, IUGR, diabetes mellitus or premature labor
Pregnant women in labor
200 women of a singleton uncomplicated full term pregnancy will be recruited during labor at the delivery room
Newborns
400 newborns belong to women in first two groups

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

300 women in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk obstetric surveillance (group 1). 100 women hospitalized at the Antenatal department due to pregnancy related hypertensive disorder, IUGR, diabetes mellitus, or premature labor will also be recruited (group 2). 200 women of a singleton uncomplicated full term pregnancy will be recruited during labor at the delivery room (group 3). Neonates born to women from group 1 and 2 (group 4).

Criteria

Inclusion Criteria:

  • Women in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk obstetric surveillance (for group 1).
  • Women with related hypertensive disorder, IUGR, diabetes mellitus, or premature labor (group 2).
  • Women of a singleton uncomplicated full term pregnancy at labor (group 3).
  • Newborns of women from group 1 and 2 (group 4).

Exclusion Criteria:

  • Multiple pregnancies.
  • Maternal chronic medical conditions.
  • Prematurity.
  • Congenital abnormalities.
  • Fetal distress.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931099

Contacts
Contact: Riva Tauman, MD 972524262025 tauman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Israel Science Foundation
  More Information

No publications provided

Responsible Party: Dr. Riva Tauman, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00931099     History of Changes
Other Study ID Numbers: TASMC-09-RT-244-CTIL
Study First Received: July 1, 2009
Last Updated: July 1, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
pregnancy
sleep disordered breathing
obstructive sleep apnea

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014