Pregnancy — Mobius® Post-cesarean Pain Randomized Control Trial
Citation(s)
Chanrachakul B, Hamontri S, Herabutya Y A randomized comparison of postcesarean pain between closure and nonclosure of peritoneum. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):31-5.
Dodd J, Pearce E, Crowther C Women's experiences and preferences following Caesarean birth. Aust N Z J Obstet Gynaecol. 2004 Dec;44(6):521-4.
Dunn EA, O'Herlihy C Comparison of maternal satisfaction following vaginal delivery after caesarean section and caesarean section after previous vaginal delivery. Eur J Obstet Gynecol Reprod Biol. 2005 Jul 1;121(1):56-60.
Kadir RA, Khan A, Wilcock F, Chapman L Is inferior dissection of the rectus sheath necessary during Pfannenstiel incision for lower segment Caesarean section? A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Sep-Oct;128(1-2):262-6. Epub 2006 Apr 18.
Nafisi S Influence of uterine exteriorization versus in situ repair on post-Cesarean maternal pain: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):135-8. Epub 2007 Feb 5.
Rafique Z, Shibli KU, Russell IF, Lindow SW A randomised controlled trial of the closure or non-closure of peritoneum at caesarean section: effect on post-operative pain. BJOG. 2002 Jun;109(6):694-8.
Thompson JF, Roberts CL, Currie M, Ellwood DA Prevalence and persistence of health problems after childbirth: associations with parity and method of birth. Birth. 2002 Jun;29(2):83-94.
Mobius Pain Study: A Randomized Controlled Trial of Standard Versus Mobius® Retraction at Cesarean Delivery
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.
