Mazzella 2010.

Trial name or title	Ursodeoxycholic Acid And Cholestasis Of Pregnancy (CERTO).
Methods	Randomised controlled trial.
Participants	118.
Interventions	Ursodeoxycholic acid 300 mg capsules 20 mg/kg body weight/day divided in 3 administrations per day from enrolment until delivery. Placebo 300 mg capsules 20 mg/kg body weight/day divided in 3 administrations per day from enrolment until delivery.
Outcomes	Primary outcome Number of participants with preterm delivery (before week 37). Secondary outcomes Pruritus on the visual analogue scale, transaminases, bile acids, fetal movement count, number of pregnancies with cardiotocography suggestive of fetal stress; Apgar score, number of pregnancies with green stained amniotic fluid.
Starting date	Estimated study start date: November 2010. Estimated primary completion date: November 2013. This study is not yet open for participant recruitment (checked on 14.02.2013).
Contact information	Professor Giuseppe Mazzella, S.Orsola‐Malpighi Hospital/University of Bologna Email: giuseppe.mazzella@unibo.it
Notes	ClinicalTrials.gov identifier: NCT01226823.

kg: kilogram
 mg: milligram