International Fetal Anesthesia Database
This trial is active, not recruiting.
|Condition||determination of neurological outcomes|
|Sponsor||Baylor College of Medicine|
|Collaborator||Children's Hospital Medical Center, Cincinnati|
|Start date||January 2015|
|End date||January 2027|
|Trial size||2000 participants|
|Trial identifier||NCT02591745, H- 35126|
This registry aims to gather anesthetic medications administered to fetuses directly as well as those administered via the mother during fetal intervention procedures. The goal is to assesss short and medium term outcomes as well as long term outcomes of these babies whao have received medication in utero. The long term outcomes will include but are not limited to neurodevelopmental outcomes.
time frame: Peri-operative
Maternal hypotension or other maternal complications
time frame: Peri-operative period
Male or female participants of any age.
Inclusion Criteria: Pregnant women, fetuses and children Exclusion Criteria: Non-pregnant women
|Official title||International Fetal Anesthesia Database|
|Principal investigator||Olutoyin A Olutoye, M.D., M.Sc.|
|Description||Advances in technology have allowed for an increase in procedures performed on the fetus in utero; these procedures involve the administration of different anesthetics (sedative- hypnotic agents and or volatile agents) to the mother and sometimes directly to the fetus in order for succesful completion of the procedure. Very few instiututions in the world perform these procedures in any significant number. The establishment of this database will serve to consolidate information regarding anesthetic drugs administered for these procedures, thereby helping to establish best practice guidelines, determine medium and short term outcomes or complications and also facilitate long term neurodevelopmental assessment of children that have undergone these procedures in utero with 5 and 10 year neurodevelopmental assessment.|
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