TREATMENT OF OBSTETRIC CHOLESTASIS

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(Date of issue: March 2015, Version: 2)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on treatment of obstetric cholestasis in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Obstetric cholestasis (OC), or intrahepatic cholestasis of pregnancy (ICP), is a condition unique to pregnancy with onset most commonly occurring in the third trimester.

Maternal symptoms of OC, which generally resolve within a few weeks of delivery, include pruritus and deranged liver enzymes, including raised serum bile acids. While the maternal effects of OC are not usually life threatening, the condition is associated with adverse effects in the fetus and neonate. Increased risk of intrauterine death (IUD), preterm delivery and fetal distress have been associated with OC. Estimates of perinatal mortality associated with OC range from 0.6-3.5%. As the risk of IUD has been found to increase toward term, many clinicians advocate induced delivery at 37-38 weeks gestation to reduce this risk. Additional fetal monitoring has not been shown to predict or to reduce the risk of adverse perinatal outcomes in pregnancies affected by obstetric cholestasis. It is recommended that women with OC receive consultant-led team-based care and give birth in a hospital unit.

Treatments for OC include topical emollients which offer temporary symptomatic relief from pruritus in some individuals. The most widely used systemic treatment is the bile acid ursodeoxycholic acid (UDCA), which appears to have a beneficial effect in some women. However, 2011 RCOG guidelines state that ‘women should be informed of the lack of robust data concerning protection against stillbirth and safety to the fetus or neonate’. Other systemic treatments include oral antihistamines which reduce the sensation of pruritus in some individuals via their sedative effects. Colestyramine, dexamethasone, rifampicin, and S-adenosylmethionine (SAMe) have also been used, however there are insufficient data on any of these treatments to confirm their safety or efficacy, and current RCOG guidelines do not recommend their general use. 

Obstetric cholestasis is associated with an elevated risk of vitamin K deficiency due to reduced enterohepatic recirculation of bile acids and resultant malabsorption of fats and fat soluble vitamins. There are no randomised controlled clinical trials that support or refute the use of vitamin K supplementation in the management of OC, although current RCOG guidelines recommend maternal vitamin K supplementation and state that postnatal vitamin K must be offered to neonates in the usual way.

Exposure to the medications included in this monograph at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.