Condition: Intrauterine Growth Restriction · Pentaerithrityl Teratnitrate in Pregnancy · Long-Term Effects to Children · Sponsor: Jena University Hospital
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention). From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany. In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.
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| Universitäts-Frauenklinik Tübingen | Tübingen, Baden-Wurttemberg, Germany | Not Yet Recruiting |
| Universitätsklinikum Ulm | Ulm, Baden-Wurttemberg, Germany | Not Yet Recruiting |
| Klinikum der Universität München | München, Bavaria, Germany | Not Yet Recruiting |
| Städtisches Klinikum München | München, Bavaria, Germany | Not Yet Recruiting |
| Medizinische Hochschule Hannover | Hanover, Lower Saxony, Germany | Not Yet Recruiting |
| Universitätsklinikum Bonn | Bonn, North Rhine-Westphalia, Germany | Not Yet Recruiting |
| Universitätsklinikum Dresden | Dresden, Saxony, Germany | Not Yet Recruiting |
| Uniklinikum Leipzig | Leipzig, Saxony, Germany | Not Yet Recruiting |
| Krankenhaus St. Elisabeth und St. Barbara | Halle, Saxony-Anhalt, Germany | Not Yet Recruiting |
| Universitätsklinikum Schleswig Holstein | Kiel, Schleswig-Holstein, Germany | Not Yet Recruiting |
| Universitätsklinikum Jena | Jena, Thuringia, Germany | Recruiting |
| Berlin Charité Campus Mitte | Berlin, Germany | Not Yet Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06534307