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Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral, Diagnostic test, Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• mothers participation in one of the PETN studies

• age above 5 years

• completion of questionnaires for self reported data

• written consent for physical examination

Locations
Other Locations
Germany
Berlin Charité Campus Mitte
NOT_YET_RECRUITING
Berlin
Berlin Vivantes Klinikum Neukölln
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
Universitätsklinikum Dresden
NOT_YET_RECRUITING
Dresden
Krankenhaus St. Elisabeth und St. Barbara
NOT_YET_RECRUITING
Halle
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Schleswig Holstein
NOT_YET_RECRUITING
Kiel
Uniklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Klinikum der Universität München
NOT_YET_RECRUITING
München
Städtisches Klinikum München
NOT_YET_RECRUITING
München
Universitäts-Frauenklinik Tübingen
NOT_YET_RECRUITING
Tübingen
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 228
Treatments
Placebo
children of mothers that have been taken placebos during participation of PETN study
PETN
children of mothers that have been taken in PETN during participation of PETN study
Sponsors
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov