Medical Abortion, Complete or Unspecified, Without Complication — Second Trimester Medical Abortion
Citation(s)
ACOG Practice Bulletin No 135: Second-trimester abortion. Obstet Gynecol. 2013 Jun;121(6):1394-1406. doi: 10.1097/01.AOG.0000431056.79334.cc. No abstract available.
Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
Borgatta L, Kapp N; Society of Family Planning Clinical guidelines. Labor induction abortion in the second trimester. Contraception. 2011 Jul;84(1):4-18. doi: 10.1016/j.contraception.2011.02.005. Epub 2011 Mar 30.
Costescu D, Guilbert E No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.
Li HWR, Gemzell-Danielsson K Mechanisms of action of emergency contraception pills. Eur J Contracept Reprod Health Care. 2019 Feb;24(1):11-12. doi: 10.1080/13625187.2018.1555663. Epub 2019 Jan 21. No abstract available.
Lohr PA, Hayes JL, Gemzell-Danielsson K Surgical versus medical methods for second trimester induced abortion. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006714. doi: 10.1002/14651858.CD006714.pub2.
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.