PreeclampsiaNCT01022619
The Association Between High Risk Pregnancy and Sleep-disordered Breathing
An observational study of Preeclampsia and Gestational Diabetes, run by Assaf-Harofeh Medical Center at 2 sites in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Gestational Diabetes, Premature Labor
- How many people
- 150 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2010to Jan 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 19 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course
Who may be able to join
- Age 19 - 39 years
- Over 26 weeks of gestation
- One of the following:
- Pre-eclampsia defined as systolic blood pressure > 140 or diastolic blood pressure > 90 and associated proteinuria > 300 mg / 24 h urine collection.
- Gestational diabetes requiring insulin treatment
- Premature contractions with associated cervical dilation or effacement
- Uncomplicated pregnancy
Who cannot join
- Chronic maternal disease
- Alcohol consumption during pregnancy
- Illicit drug abuse at any time in life
- Fetal abnormalities on obstetric ultrasound
Trial locations and contacts
2 sites in 1 country.
Tal Biron-Shental, MD contact
Israel2 sites
Meir Hospital
Kfar Saba, 44281
Tal Biron Shental, MD
Tal Biron-Shental, MD
Asaf Harofeh Medical Center
Tsrifin, 70300
Arnon Elizur, MD
Arnon Elizur, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Preeclampsia, Gestational Diabetes, Premature Labor
- Keywords
- Sleep apnea, high risk pregnancy, fetal outcome, cord blood
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Obstetric Labor, Premature, Sleep Apnea Syndromes
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
Measured: At time of assessment
Secondary outcomes (3)
birth weight, apgar score
Measured: at birth
inflammatory markers in cord blood
Measured: at birth
growth and development during the 1st year of life
Measured: at age 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Meir Medical Center
- Investigators
- Isaac Shpirer, MD, Principal investigator, Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022619
- Sponsor's protocol ID
- 61/09
- Status last verified
- Nov 2009
- First submitted
- 26 Nov 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between High Risk Pregnancy and Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT01022619
- Acronym / sponsor ID
- 61/09
- Conditions
- Preeclampsia, Gestational Diabetes, Premature Labor
- Keywords
- Sleep apnea, high risk pregnancy, fetal outcome, cord blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Meir Medical Center
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- First posted
- 1 Dec 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women in third trimester admitted to the high-risk pregnancy unit and women with uncomplicated pregnancy attending a pre-labor course
Key inclusion criteria (7 listed)
- Age 19 - 39 years
- Over 26 weeks of gestation
- One of the following:
Key exclusion criteria (4 listed)
- Chronic maternal disease
- Alcohol consumption during pregnancy
- Illicit drug abuse at any time in life
- Fetal abnormalities on obstetric ultrasound
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
apnea-hypopnea index
Time frame: At time of assessment
3 secondary outcomes
birth weight, apgar score
Time frame: at birth
inflammatory markers in cord blood
Time frame: at birth
growth and development during the 1st year of life
Time frame: at age 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
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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.
Tal Biron-Shental, MD contact
Isaac Shpirer, MD principal investigator
Pulmonary division ans sleep laboratory, Asaf Harofeh Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Gestational Diabetes, run by Assaf-Harofeh Medical Center at 2 sites 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 7 inclusion and 4 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 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tal Biron-Shental, MD (shentalt@inter.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea-hypopnea index (time frame: At time of assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2009.