NCT03172858 - 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)

Bond DM, Middleton P, Levett KM, van der Ham DP, Crowther CA, Buchanan SL, Morris J
Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome. Cochrane Database Syst Rev. 2017 Mar 3;3(3):CD004735. doi: 10.1002/14651858.CD004735.pub4.
Cabrera IB, Quinones JN, Durie D, Rust J, Smulian JC, Scorza WE
Use of intracervical balloons and chorioamnionitis in term premature rupture of membranes. J Matern Fetal Neonatal Med. 2016 Mar;29(6):967-71. doi: 10.3109/14767058.2015.1027191. Epub 2015 Sep 25.
Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR
Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
Mackeen AD, Walker L, Ruhstaller K, Schuster M, Sciscione A
Foley catheter vs prostaglandin as ripening agent in pregnant women with premature rupture of membranes. J Am Osteopath Assoc. 2014 Sep;114(9):686-92. doi: 10.7556/jaoa.2014.137.

A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Prelabor Rupture of Membranes and Unripe Cervices

Clinical trial NCT03172858 - References