Dean G, Jacobs AR, Goldstein RC, Gevirtz CM, Paul ME The safety of deep sedation without intubation for abortion in the outpatient setting. J Clin Anesth. 2011 Sep;23(6):437-42. doi: 10.1016/j.jclinane.2011.05.001. Epub 2011 Aug 9.
Reeves MF, Lohr PA, Hayes JL, Harwood BJ, Creinin MD Doxycycline serum levels at the time of dilation and evacuation with two dosing regimens. Contraception. 2009 Feb;79(2):129-33. doi: 10.1016/j.contraception.2008.09.006. Epub 2008 Nov 13.
Risser W Side effects of doxycycline in adolescents treated for pelvic inflammatory disease. J Pediatr Adolesc Gynecol. 2011 Jun;24(3):e87. doi: 10.1016/j.jpag.2011.02.010.
Sawaya GF, Grady D, Kerlikowske K, Grimes DA Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol. 1996 May;87(5 Pt 2):884-90.
A Randomized Controlled Trial of Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline
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.
