NCT05333731 - 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)

Bellussi F, Livi A, Diglio J, Lenzi J, Magnani L, Pilu G
Timing of induction for term prelabor rupture of membranes and intravenous antibiotics. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100245. doi: 10.1016/j.ajogmf.2020.100245. Epub 2020 Oct 6.
Fishel Bartal M, Sibai BM, Ilan H, Fried M, Rahav R, Alexandroni H, Schushan Eisan I, Hendler I
Trial of labor after cesarean (TOLAC) in women with premature rupture of membranes(). J Matern Fetal Neonatal Med. 2020 Sep;33(17):2976-2982. doi: 10.1080/14767058.2019.1566312. Epub 2019 Jan 17.
Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA
Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1:CD005302. doi: 10.1002/14651858.CD005302.pub3. Review.
Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217
Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study

Details for clinical trial NCT05333731

Clinical trial NCT05333731 - References