Preterm Birth — Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
Citation(s)
Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA Cervical pessary for preventing preterm birth. Cochrane Database Syst Rev. 2013 May 31;(5):CD007873. doi: 10.1002/14651858.CD007873.pub3. Review.
Berghella V, Mackeen AD Cervical length screening with ultrasound-indicated cerclage compared with history-indicated cerclage for prevention of preterm birth: a meta-analysis. Obstet Gynecol. 2011 Jul;118(1):148-55. doi: 10.1097/AOG.0b013e31821fd5b0.
Beta J, Akolekar R, Ventura W, Syngelaki A, Nicolaides KH Prediction of spontaneous preterm delivery from maternal factors, obstetric history and placental perfusion and function at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):75-83. doi: 10.1002/pd.2662.
Dodd JM, Jones L, Flenady V, Cincotta R, Crowther CA Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD004947. doi: 10.1002/14651858.CD004947.pub3. Review.
Hui SY, Chor CM, Lau TK, Lao TT, Leung TY Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol. 2013 Apr;30(4):283-8. doi: 10.1055/s-0032-1322550. Epub 2012 Aug 8.
Orzechowski KM, Boelig RC, Berghella V Cervical Length Screening in Asymptomatic Women at High Risk and Low Risk for Spontaneous Preterm Birth. Clin Obstet Gynecol. 2016 Jun;59(2):241-51. doi: 10.1097/GRF.0000000000000195.
Sotiriadis A, Papatheodorou S, Kavvadias A, Makrydimas G Transvaginal cervical length measurement for prediction of preterm birth in women with threatened preterm labor: a meta-analysis. Ultrasound Obstet Gynecol. 2010 Jan;35(1):54-64. doi: 10.1002/uog.7457.
Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
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.
