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.
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.
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted2 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Israel Science Foundation
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 32118576Kidron 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Outcome of Sleep Disordered Breathing During Pregnancy
- ClinicalTrials.gov ID
- NCT00931099
- Acronym / sponsor ID
- TASMC-09-RT-244-CTIL
- Conditions
- Pregnant Women
- Keywords
- pregnancy, sleep disordered breathing, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Israel Science Foundation
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Multiple pregnancies.
- Maternal chronic medical conditions.
- Prematurity.
- Congenital abnormalities.
- Fetal distress.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neonatal neurobehavioral measures
Time frame: first 48 h of life, age of 11 weeks and 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Derived from this study: PubMed 32118576Dunietz 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.
- Derived from this study: PubMed 30903184Kidron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.