NCT06069596 - 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)

Azarkish F, Janghorban R, Bozorgzadeh S, Merbalouchzai F, Razavi M, Badiee M
Effect of lubricant gel on the length of the first stage of labour and perineal trauma in primiparous women. J Obstet Gynaecol. 2022 Jul;42(5):867-871. doi: 10.1080/01443615.2021.1946021. Epub 2021 Sep 27.
Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, Koc A, Soylemez F
Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. J Obstet Gynaecol. 2017 Aug;37(6):714-718. doi: 10.1080/01443615.2017.1288711. Epub 2017 Mar 21.

Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study

Clinical trial NCT06069596 - References