Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis.
BACKGROUND
Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 4500 women per year in the UK. Affected women develop itching and occasionally jaundice. More importantly, the condition is associated with premature delivery, fetal distress and is believed to be an important cause of stillbirth. However, even now, there is no clear evidence as to whether the most popular treatment, a drug called ursodeoxycholic acid is beneficial to the baby, or even if it is safe in pregnancy. Nor do we know whether planned early delivery of the baby at 37-38 weeks, another popular treatment, does more good than harm. A randomised trial to evaluate both ursodeoxycholic acid and timed delivery is needed but will be complicated and expensive. We plan a preliminary study, Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis (Acronym PITCH- Pregnancy Intervention Trial in Cholestasis) trial, to evaluate the feasibility of a larger trial. The trial is funded by the NHS Research for Patient Benefit (RfPB) Programme.


METHODS
PITCH is a multi-centre, double blinded, randomised, controlled, factorial design trial. The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months. In this pilot trial we aim to collect data to finalize the design for the main trial. This will include measuring trial recruitment rate, including recruitment to each factorial comparison separately. We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations. We will use these data to design the main trial.


CONCLUSIONS
The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively. If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment. Conversely, if one or both the treatments turn out to be ineffective or even harmful, they will be stopped and researchers will work at developing other modes of treatment.
Gurung
Vinita
V
School of Clinical Sciences, Division of Human Development, University of Nottingham, Nottingham, UK. gurungvinita@doctors.org.uk
Williamson
Catherine
C
Chappell
Lucy
L
Chambers
Jenny
J
Briley
Annette
A
Broughton Pipkin
Fiona
F
Thornton
Jim
J
D000293:Adolescent; D000328:Adult; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D002779:Cholestasis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007751:Labor, Induced; D008875:Middle Aged; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D006113:United Kingdom; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid