International Fetal Anesthesia Database

NCT ID: NCT02591745

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2030-01-31

Brief Summary

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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

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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

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Determination of Neurological Outcomes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Pregnant women, fetuses and children

Exclusion Criteria: Non-pregnant women
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Titilopemi Aina, MD MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Titilopemi Aina, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H- 35126

Identifier Type: -

Identifier Source: org_study_id

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