CTIS2024-512679-11-00RecruitingPhase 1
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
niversitaetsklinikum Erlangen AöR0 sites64 target enrollmentStarted: March 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- In Utero to 64 (—)
- Sex
- All
Inclusion Criteria
- •>= 18 years of age (mother), third trimester of pregnancy (mother), non-smoker (mother), A. uterina doppler ultrasound at least one-sided without pathological findings (mother), cardiac disorder with at least one underdeveloped left ventricular structure detected by echocardiography (fetus), sufficient fetal cardiac function (fetus)
Exclusion Criteria
- •alcohol or drug abuse (mother), underlying disease or chromosomal abnormality which might influence the effect of MFHO (fetus), hemodynamic factors with influence on filling/emptying of the left heart which might affect MFHO efficacy (fetus), fetal cardiac failure (fetus), Hydrops fetalis (fetus), severe growth retardation (fetus), no flow in A. umbilicalis (fetus), severe extracardiac malformations (fetus), visit 2: inadequate response to O2 provocation during echocardiography (fetus), multiple pregnancy (mother), adipositas permagna (BMI>40) (mother), diabetes melllitus, insulin-dependent (mother), obstetrical issues (e.g. Cervix uteri <25mm, premature contractions, preeclampsia, eclampsia, HELLP Syndrome, …) (mother), fetus impossible to evaluate by echocardiography (mother), patholog. utero-placental resistance (mother), cardiac failure (NYHA III/IV or decompensated) (mother), severe COPD, hypercapnia (mother)
Investigators
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