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Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heart
EU CTIS ID: 2024-512679-11-00
What this study is testing
Evidence of efficacy of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy on growth of underdeveloped fetal left ventricular structures
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >= 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)
You likely can't join if
- 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)
See the full eligibility 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)
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, in utero. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.