NCT05218837 - 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)

Bols EM, Hendriks EJ, Berghmans BC, Baeten CG, Nijhuis JG, de Bie RA
A systematic review of etiological factors for postpartum fecal incontinence. Acta Obstet Gynecol Scand. 2010 Mar;89(3):302-14. doi: 10.3109/00016340903576004. Review.
McPherson KC, Beggs AD, Sultan AH, Thakar R
Can the risk of obstetric anal sphincter injuries (OASIs) be predicted using a risk-scoring system? BMC Res Notes. 2014 Jul 24;7:471. doi: 10.1186/1756-0500-7-471.
Nilsson IEK, Åkervall S, Molin M, Milsom I, Gyhagen M
Symptoms of fecal incontinence two decades after no, one, or two obstetrical anal sphincter injuries. Am J Obstet Gynecol. 2021 Mar;224(3):276.e1-276.e23. doi: 10.1016/j.ajog.2020.08.051. Epub 2020 Au
Webb SS, Hemming K, Khalfaoui MY, Henriksen TB, Kindberg S, Stensgaard S, Kettle C, Ismail KM
An obstetric sphincter injury risk identification system (OSIRIS): is this a clinically useful tool? Int Urogynecol J. 2017 Mar;28(3):367-374. doi: 10.1007/s001

Research Plan for Development and Validation of a Logistic Regression Derived Algorithm to Estimate the Risk of Obstetric Anal Sphincter Injury in High- and Low-risk Scenarios.

Details for clinical trial NCT05218837

Clinical trial NCT05218837 - References