Dalui R, Suri V, Ray P, Gupta I Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7.
James C, Peedicayil A, Seshadri L Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32.
Lyndrup J, Nickelsen C, Weber T, Mølnitz E, Guldbaek E Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Eur J Obstet Gynecol Reprod Biol. 1994 Mar 15;53(3):189-97.
Manabe Y, Manabe A, Takahashi A F prostaglandin levels in amniotic fluid during balloon-induced cervical softening and labor at term. Prostaglandins. 1982 Feb;23(2):247-56.
St Onge RD, Connors GT Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):687-90.
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
