Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 1 in 150 pregnancies, about 4500 women per year in the UK. Affected women develop severe itching and sometimes jaundice. More importantly, the condition is associated with increased risks to the unborn baby, premature delivery, and is believed to be an important cause of stillbirth. MedDRA version: 9.1 Level: LLT Classification code 10049055 Term: Cholestasis of pregnancy
Conditions
Interventions
Trade Name: Ursofalk Capsule
Product Name: Ursofalk capsule
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. 24+0 to 37+6weeks pregnant; (24+0 – 40+6 weeks) UDCA arm only 2. age 18-55 years 3. Diagnosed as OC based on history of pruritus in pregnancy and deranged biochemical parameter (random bile acid >14 µmoles/litre or raised ALT over 100 U/L) 4. Clinician responsible for care is uncertain whether UDCA or early delivery is beneficial 5. Patients who otherwise fulfil the recruitment criteria, but incidentally have either hepatitis C, or cholelithiasis, or both, are eligible and may be included. 6. Women with multiple pregnancies who are otherwise eligible may be included in the UDCA/placebo comparison only. 7. Willing to participate in the trial and able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Dermatological and allergic causes for pruritus 2. Other causes of pruritus and deranged liver enzymes (except hepatitis C and cholelithiasis see above). 3. Hepatitis A, hepatitis B, pre-eclampsia, primary hepatic disorders, alpha-1 antitrypsin deficiency and current medications causing deranged liver enzymes. 4. Women unable or unwilling to consent 5. Known lethal fetal anomalies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to collect data to finalise the design of a factorial trial for the main to test the hypotheses that the use of a ursodeoxycholic acid reduces itching, pre-term delivery and fetal morbidity and that active management by planned delivery at 37-38 weeks reduces fetal morbidity. In the present project we wish to collect data to finalise the design of such a trial specifically to: . Measure recruitment to the two factorial interventions separately;Secondary Objective: Secondary objecties are: 1. Relate recruitment rates to disease severity 2. Estimate a realistic recruitment rate for the definitive trial 3. Measure acceptability of randomisation among potential participants offered trial entry 4. Measure compliance with each treatment arm 5. Measure the completeness of outcome data 6. Finalise the design including the sample size calculation for the definitive trial 7. Measure medium term (6 weeks) maternal and fetal outcomes for the definitive trial. ;Primary end point(s): Primary endpoints: • To measure total recruitment rate per 1000 deliveries/ annum • To measure total recruitment rate per eligible women | — |
Countries
United Kingdom
Outcome results
None listed