Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02591745

International Fetal Anesthesia Database

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Determination of Neurological Outcomes

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women, fetuses and children

Exclusion criteria

Non-pregnant women

Treatment and study plan

Fetal intervention

Procedure

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

Primary outcomes

  1. Fetal complications

    Time frame: Peri-operative

    resuscitation efforts during surgery or peri-operative demise

Secondary outcomes

  1. Maternal hypotension or other maternal complications

    Time frame: Peri-operative period

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • The University of Texas Health Science Center, Houston
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Acronym: iFAD

Important dates

Study start
2015
Primary completion
2027
Study completion
2030
First posted
Oct 30, 2015
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.