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 个研究点目标入组 64 人开始时间: 2024年3月12日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•>= 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)

发起方

niversitaetsklinikum Erlangen AöR