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Pregnant WomenNCT00931099

Fetal Outcome of Sleep Disordered Breathing During Pregnancy

An observational study of Pregnant Women, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pregnant Women
How many people
1,000 participants
Where
1 siteIsrael
Study dates
Sep 2009to Sep 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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).

Who cannot join

  • Multiple pregnancies.
  • Maternal chronic medical conditions.
  • Prematurity.
  • Congenital abnormalities.
  • Fetal distress.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

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.

Read more

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.
Read the 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.

Conditions
Pregnant Women
Keywords
pregnancy, sleep disordered breathing, obstructive sleep apnea
Medical subject headings
Sleep Apnea Syndromes, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00931099
Study groupRoleWhat they receive
Low risk pregnant women300 women in the third trimester of a singleton uncomplicated pregnancy, who attend a low risk obstetric surveillance
High risk pregnant women100 women hospitalized at the Antenatal department due to pregnancy related hypertensive disorder, IUGR, diabetes mellitus or premature labor
Pregnant women in labor200 women of a singleton uncomplicated full term pregnancy will be recruited during labor at the delivery room
Newborns400 newborns belong to women in first two groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neonatal neurobehavioral measures

    Measured: first 48 h of life, age of 11 weeks and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2012 (estimated)
  4. Study completionSep 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931099
Sponsor's protocol ID
TASMC-09-RT-244-CTIL
Status last verified
Jul 2009
First submitted
1 Jul 2009
Last updated
2 Jul 2009
Results posted
No

Publications

  • Dunietz GL, Sever O, DeRowe A, Tauman R. Sleep position and breathing in late pregnancy and perinatal outcomes. J Clin Sleep Med. 2020 Jun 15;16(6):955-959. doi: 10.5664/jcsm.8416.

    PubMed 32118576
  • Kidron D, Bar-Lev Y, Tsarfaty I, Many A, Tauman R. The effect of maternal obstructive sleep apnea on the placenta. Sleep. 2019 Jun 11;42(6):zsz072. doi: 10.1093/sleep/zsz072.

    PubMed 30903184

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnant Women, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Riva Tauman, MD (972524262025, tauman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

neonatal neurobehavioral measures (time frame: first 48 h of life, age of 11 weeks and 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.

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