Diaferia 1996.
| Methods | Randomised controlled trial. | |
| Participants | 16 women randomised. Setting: Bari, Italy. Inclusion criteria: women aged between 20‐39 with ICP in the third trimester of pregnancy, where pruritus appeared after week 29 of pregnancy. Exclusion criteria: hepatitis A, B, C, CMV and HSV; chronic liver disease; urinary tract infection; gestational diabetes; hypertension. |
|
| Interventions |
UDCA (n = 8). 600 mg/day of UDCA in 2 oral doses for 20 days after week 30 of gestation. Placebo (n = 8). Placebo (vitamin‐supradyn) in 2 oral doses for 20 days. Participants were admitted in the hospital during the duration of the study. No other drug was used to improve pruritus and LFTs. The severity of pruritus was assessed before randomisation and repeated every 5 days using the following score: 0 = absence of pruritus; 1 = occasional pruritus; 2 = discontinuous pruritus every day, with prevailing asymptomatic lapses; 3 = discontinuous pruritus with prevailing symptomatic lapses; 4 = constant pruritus, day and night. Blood samples were collected weekly for assays of liver function and bile acids. Ultrasound examinations and CTGs were performed to assess the fetus. |
|
| Outcomes |
Maternal: pruritus; liver function and bile acid assays; mode of birth; PPH; adverse effects. Fetal/neonatal: fetal distress; gestation at birth; birthweight; Apgar score at 1 and 5 minutes; adverse effects. |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described only as "randomised". |
| Allocation concealment (selection bias) | Unclear risk | Described only as "randomised". |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "double‐blind, placebo‐controlled" ‐ the investigators and the participants were blinded to the treatment allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up were reported. |
| Selective reporting (reporting bias) | Unclear risk | Perinatal death not reported. |
| Other bias | Low risk | No other additional bias noted. |