NCT03330119 - Clinical Trial References

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.

Citation(s)

Committee opinion no
633: Alcohol abuse and other substance use disorders: ethical issues in obstetric and gynecologic practice. Obstet Gynecol. 2015 Jun;125(6):1529-1537. doi: 10.1097/01.AOG.0000466371.86393.9b.
Dowell D, Haegerich TM, Chou R
CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464. Review.
Guttuso T Jr, Shaman M, Thornburg LL
Potential maternal symptomatic benefit of gabapentin and review of its safety in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:280-3. doi: 10.1016/j.ejogrb.2014.08.013. Epub 2014 Aug 17. Review.
Moore A, Costello J, Wieczorek P, Shah V, Taddio A, Carvalho JC
Gabapentin improves postcesarean delivery pain management: a randomized, placebo-controlled trial. Anesth Analg. 2011 Jan;112(1):167-73. doi: 10.1213/ANE.0b013e3181fdf5ee. Epub 2010 Nov 16.
Nelson G, Kalogera E, Dowdy SC
Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12. Review.
Sachs HC; Committee On Drugs
The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. doi: 10.1542/peds.2013-1985. Epub 2013 Aug 26.
Wheeler M, Oderda GM, Ashburn MA, Lipman AG
Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80.

Determining the Effect of an "Alternate Recovery Protocol" Versus Current Standard of Care After Cesarean Section

Clinical trial NCT03330119 - References