NCT02492152 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Eason E, Labrecque M, Wells G, Feldman P
Preventing perineal trauma during childbirth: a systematic review. Obstet Gynecol. 2000 Mar;95(3):464-71.
Riener R, Leypold K, Brunschweiler A, Schaub A, Bleul U, Wolf P
Quantification of friction force reduction induced by obstetric gels. Med Biol Eng Comput. 2009 Jun;47(6):617-23. doi: 10.1007/s11517-009-0460-1. Epub 2009 Feb 24.
Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbühler V
Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. J Perinat Med. 2008;36(2):129-35. doi: 10.1515/JPM.2008.024.

Randomised ,Open Label in Meir Medical Center. Study the Potential of Dianatal Gel to Reduce the Rate of Episiotomy and Vaginal Tears in Birth

Clinical trial NCT02492152 - References