ChorioamnionitisNCT01778725
Early Identification of Brain Insult in Chorioamnionitis
An observational study of Chorioamnionitis and Cerebral Palsy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chorioamnionitis, Cerebral Palsy
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Aug 2015
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with premature rupture of the amniotic sac.
Who may be able to join
- Rupture of the amniotic sac before 32 weeks
- Gestational age less than 32 weeks
- Singleton
Who cannot join
- Intrauterine growth restriction
- Positive TORCH
- Fetus' brain malformation
- Fetus' brain hemorrhage
- Maternal medication with teratogenic effect
Trial locations and contacts
1 site in 1 country.
Israel1 site
Chaim Seba Medical Center
Ramat Gan, 56210
Boaz Weisz, M.D.
Omer Bar-Yosef, M.D.-Ph.D.
About this study
Official title: S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.
The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.
- Conditions
- Chorioamnionitis, Cerebral Palsy
- Keywords
- Chorioamnionitis, S100B, Brain, Neuro-development
- Medical subject headings
- Chorioamnionitis, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental assessment
Developmental assessment at 18 month
- Vineland Adaptive Behavior Scales
- Griffith Mental Development Scales
Measured: 18 month
Developmental assessment
Developmental assessment at term and 3 month
- Neurological examination
- Test of infant motor performance
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- More trials run by Sheba 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Boaz Weisz, M.D., Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778725
- Sponsor's protocol ID
- SHEBA-12-9616-BW-CTIL
- Status last verified
- Jan 2013
- First submitted
- 25 Nov 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT01778725
- Acronym / sponsor ID
- SHEBA-12-9616-BW-CTIL
- Conditions
- Chorioamnionitis, Cerebral Palsy
- Keywords
- Chorioamnionitis, S100B, Brain, Neuro-development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 29 Jan 2013 (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.
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.
The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with premature rupture of the amniotic sac.
Key inclusion criteria (3 listed)
- Rupture of the amniotic sac before 32 weeks
- Gestational age less than 32 weeks
- Singleton
Key exclusion criteria (5 listed)
- Intrauterine growth restriction
- Positive TORCH
- Fetus' brain malformation
- Fetus' brain hemorrhage
- Maternal medication with teratogenic effect
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
Developmental assessment
Time frame: 18 month
Developmental assessment at 18 month 1. Vineland Adaptive Behavior Scales 2. Griffith Mental Development Scales
Developmental assessment
Time frame: 3 month
Developmental assessment at term and 3 month 1. Neurological examination 2. Test of infant motor performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
Related trials for Chorioamnionitis
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Meconium-stained Amniotic Fluid, Chorioamnionitis
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
Enrolling by invitation
Planned Early Induction of Labor vs Expectant Management for PROM
Premature Rupture of Membranes (PROM)
Active, not recruitingObservational study
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
Intrapartum Maternal Fever, Clinical Chorioamnionitis
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.
Boaz Weisz, M.D. principal investigator
Chaim Sheba Medical Center
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 Chorioamnionitis and Cerebral Palsy, run by Sheba 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 3 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 29 Jan 2013. 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 Omer Bar - Yosef, M.D.- Ph.D. (972-52-6667344, omerbary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental assessment (time frame: 18 month). The study lists 2 primary outcomes in all. 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 29 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.