Fetal Membranes, Premature Rupture — PROMComplete for Determination of Rupture of Fetal Membranes
Citation(s)
ACOG Committee on Practice Bulletins-Obstetrics ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19.
Chen FC, Dudenhausen JW Comparison of two rapid strip tests based on IGFBP-1 and PAMG-1 for the detection of amniotic fluid. Am J Perinatol. 2008 Apr;25(4):243-6. doi: 10.1055/s-2008-1066876.
Cousins LM, Smok DP, Lovett SM, Poeltler DM AmniSure placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005 Aug;22(6):317-20.
El-Messidi A, Cameron A Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X. Review.
Mercer BM Preterm premature rupture of the membranes: diagnosis and management. Clin Perinatol. 2004 Dec;31(4):765-82, vi. Review.
Practice bulletins No 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-30. doi: 10.1097/01.AOG.0000435415.21944.8f.
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.
