International Fetal Anesthesia Database

Active, not recruiting

• Conditions: Determination of Neurological Outcomes

• Registration Number: NCT02591745
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Pregnant women, fetuses and children

Read More

Exclusion Criteria

Non-pregnant women

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal complications	Peri-operative	resuscitation efforts during surgery or peri-operative demise

Secondary Outcome Measures

Name	Time	Method
Maternal hypotension or other maternal complications	Peri-operative period

Trial Locations

Locations (1)

Texas Children's Hospital, Baylor College of Medicine; 🇺🇸 Houston, Texas, United States