Overview

This trial is active, not recruiting.

Condition determination of neurological outcomes
Treatment fetal intervention
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Fetal complications
time frame: Peri-operative

Secondary Outcomes

Measure
Maternal hypotension or other maternal complications
time frame: Peri-operative period

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Pregnant women, fetuses and children Exclusion Criteria: Non-pregnant women

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.