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Safety of Dianatal® Obstetric Gel 

         - Safe for mother and child

 

 

Product characteristics

Dianatal® Obstetric Gel is sterile, non-allergenic, latex-free, bacterizide, well tolerated by mucous membranes and eyes, electroconductive and isotonic.

 

Clinical trial

Dianatal® Obstetric Gel was tested for efficacy and safety in a randomized study in more than 300 births at the University Frauenklinik in Basel, the Kantonsspital in Frauenfeld and the Kantonsspital in Schaffhausen. In the course of this clinical trial, no side effects were detected for the mother or the newborn.

 

Side effects

To date no cases of side effects have been reported.

 

Biocompatibility and use in pregnancy

Dianatal® Obstetric Gel has been tested in accordance with international guidelines in relation to biocompatibility. Based on the results of these tests, there are no indications of a harmful effect for the mother or the newborn infant.

(Agar Diffusion Test, Buehler Sensitation Test, Embryotoxicity Test, Human Blood Hemolysis Test, Intacutaneous Injection Test, Oral Irritation Test, Primary Ocular Irritation Test, Primary Skin Irritation Test, Primary Vaginal Exposure Test, Rabbit Pyrogen Test, Systemic Injection Test)

Press release UK Nov 09

 more

Lunch Symposium 24. German Congress for Perinatal Medicine

2009, ICC Berlin, Chair: Prof. St. Schmidt 

Workshop obstetric gel, Chair Prof. E. Saling, Berlin

13. Congress of the German Society of Prenatal Medicine 

2008, Bonn