NCT02591745

International Fetal Anesthesia Database

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Determination of Neurological Outcomes

Interventions

Type	Name	Description
PROCEDURE	Fetal intervention	Type of fetal conditions requiring intervention and medications administered to fetuses undergoing varying types of fetal intervention will be documeted in this database.

Timeline

• Start date: 2015-01-01
• Primary completion: 2027-01-01
• Completion: 2030-01-01
• First posted: 2015-10-30
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States