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Status unknownNCT01778725Updated Jan 29, 2013

Early Identification of Brain Insult in Chorioamnionitis

An observational study in Chorioamnionitis and Cerebral Palsy, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-29.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 55 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Chorioamnionitis
  • Cerebral Palsy

Keywords

  • Chorioamnionitis, S100B, Brain, Neuro-development
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In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's planned enrollment of 90 is below the median of 125 across 14 observational studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women with premature rupture of the amniotic sac.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Rupture of the amniotic sac before 32 weeks
  • Gestational age less than 32 weeks
  • Singleton

Exclusion criteria

Exclusion Criteria:

  • Intrauterine growth restriction
  • Positive TORCH
  • Fetus' brain malformation
  • Fetus' brain hemorrhage
  • Maternal medication with teratogenic effect
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Developmental assessment

    Developmental assessment at 18 month 1. Vineland Adaptive Behavior Scales 2. Griffith Mental Development Scales

    Time frame: 18 month

  2. Developmental assessment

    Developmental assessment at term and 3 month 1. Neurological examination 2. Test of infant motor performance

    Time frame: 3 month

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Study locations

1 site
  • Chaim Seba Medical Center
    Ramat-Gan, 56210, Israel
    • Boaz Weisz, M.D. · Principal investigator
    • Omer Bar-Yosef, M.D.-Ph.D. · Sub investigator
    • Yoav Yinon, M.D. · Sub investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01778725
Responsible party
Sponsor
First posted
Jan 29, 2013
Start date
Jan 2013
Primary completion
Aug 2015 (estimated)
Last update
Jan 29, 2013

Study contacts

Omer Bar - Yosef, M.D.- Ph.D.
Contact
omerbary@gmail.com
972-52-6667344
Boaz Weisz, M.D.
principal investigator · Chaim Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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