NCT02815865 - 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)

1
Martin JA, Hamilton BE, Ventura SJ, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep 2012;61:1-72. 2. Jozwiak M, Oude Rengerink K, Ten Eikelder ML, van Pampus MG, Dijksterhuis MG, de Graaf IM, et al. Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature. European journal of obstetrics, gynecology, and reproductive biology. 2013;170(1):137-45. 3. Carbone JF, Tuuli MG, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstetrics and gynecology. 2013;121(2 Pt 1):247-52. 4. Kashanian M, Akbarian AR, Fekrat M. Cervical ripening and induction of labor with intravaginal misoprostol and Foley catheter cervical traction. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2006;92(1):79-80. 5. Chung JH, Huang WH, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. AJOG. 2003;189(4):1031-5. 6. LD Levine, S. Parry. MA. Elovitz. Foley or Misoprostol for the Management of Induction (The 'FOR MOMI' trial): A four-arm randomized clinical trial. AJOG 214, 1, S4, 2016.

A Randomized Controlled Study Comparing Cervical Foley Catheter, Vaginal Dinoprostone and a Combination of the Two Methods for Induction of Labor

Clinical trial NCT02815865 - References