Prospective, randomized, controlled, open, multicenter clinical trial on the efficacy and safety of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy to treat underdeveloped left ventricular structures of the fetus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512679-11-00

Enrollment

Registered

2024-03-25

Start date

2025-04-25

Completion date

Unknown

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unborn baby with developmental disorder of the left side of the heart

Brief summary

median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation

Interventions

DRUGLOX medicAL 100% (V/V) Gas zur medizinischen Anwendung

DRUGkälteverflüssigt

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026