Medicines Q&As
Q&A 354.2
What guidance is there available on the use of vitamin K for the
management of obstetric cholestasis?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Date prepared 31st July 2012
Background
Obstetric cholestasis has been described as a multifactorial condition of pregnancy characterised by
intense pruritus with the absence of a skin rash, with abnormal liver function tests, neither of which
have an alternative cause and both of which resolve after birth(1). The use of vitamin K as part of the
management of obstetric cholestasis is common practice. Obstetric cholestasis can result in reduced
absorption of dietary fats, due to failure of the excretion of bile salts into the gastrointestinal tract and
reduced micelle formation (1). As vitamin K is fat-soluble patients with fat malabsorption may become
deficient (2). Vitamin K is required for the production of blood clotting factors and proteins required
for the normal calcification of bone (2). Whether to use a water soluble or fat soluble preparation of
vitamin K for the management of obstetric cholestasis is a commonly asked question. In addition,
there have been reports of neonatal toxicity following menadiol sodium diphosphate administration in
late pregnancy or during delivery (3).
Answer
Menadiol sodium phosphate is a water-soluble synthetic vitamin K derivative that can be given orally
for the prevention or treatment of vitamin K deficiency due to malabsorption, as it is absorbed without
dependence on the presence of bile salts (2, 3). Phytomenadione however, is the fat-soluble
synthetic vitamin K derivative and requires the presence of bile for its absorption from the
gastrointestinal tract when administered orally (2, 3); a parenteral preparation may be required in
patients with fat malabsorption to ensure clinical effectiveness (3).
There are two authoritative guidance documents providing advice on the use and choice of vitamin K
preparation for the management of obstetric cholestasis and there are also a number of general
review articles.
Websites

Royal College of Obstetricians and Gynaecologists: Green-top Guideline No. 43. Obstetric
Cholestasis. April 2011(1)
http://www.rcog.org.uk/files/rcog-corp/GTG43obstetriccholestasis.pdf

UK Teratology Information Service (UKTIS) formerly known as the National Teratology
Information Service: Treatment of obstetric cholestasis in pregnancy. December 2009 (3)
http://www.toxbase.org/upload/Pregnancy%20pdfs/Obstetric%20cholestasis%202009.pdf
Subscription to Toxbase may be required. UKTIS also operate a telephone information
service.
In April 2011, the Royal College of Obstetricians and Gynaecology (1), updated the obstetric
cholestasis guidelines regarding treatment with vitamin K due to BNF recommendations of avoiding
water soluble vitamin K (menadiol sodium phosphate) therapy late in pregnancy and labour, because
of a risk of neonatal toxicity. The UK Teratology Information (3) Service refers to the Royal College of
Obstetricians and Gynaecology guidelines, but their monograph has yet to be updated to include the
new recommendations)
From the NHS Evidence website www.evidence.nhs.uk
1
Medicines Q&As
Publications and Other Resources
General Review Articles
 Saleh MM and Abdo KR. Intrahepatic cholestasis of pregnancy. Journal of Women’s Health
2007; 16: 833-841 (4).
 Saleh MM, Abdo KR. Consensus on the management of obstetric cholestasis: National UK
Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114: 99-103 (5).
Correspondence relating to the above:
 Fiadjoe PK and Overton C. Consensus on the management of obstetric cholestasis: National
UK Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114: 656 (6).
 Memtsa M, Pun S, West P et al. Consensus on the management of obstetric cholestasis:
National UK Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114:
910-911 (7).
Clinical Experts

UK Teratology Information Service. Tel: 0844 892 0909. This information service is available
to healthcare professionals only and not members of the public.
Summary




There are currently two published authoritative guidance documents on the management of
obstetric cholestasis (1, 3).
Both give recommendations on the use of vitamin K in the management of obstetric
cholestasis (1, 3).
The Royal College of Obstetricians and Gynaecologists recommend that a discussion should
take place with the woman regarding the use of vitamin K. Women should be advised that
when prothrombin time is prolonged, the use of water-soluble vitamin K (menadiol sodium
phosphate) in doses of 5-10mg daily is indicated. When prothrombin time is normal, water
soluble vitamin K (menadiol sodium phosphate) in low doses should be used only after careful
counselling about the likely benefits and theoretical risks.
The UK Teratology Information Service (UKTIS) document (3) cites the Royal College of
Obstetricians and Gynaecologists (RCOG) recommendations (1) from the previous obstetric
cholestasis guidelines published in 2006. At the time of writing, the UKTIS guidance has yet
to be updated to include the latest RCOG advice for the use of water-soluble vitamin K
(menadiol sodium phosphate).
Limitations
A discussion of the neonatal toxicity associated with the use of vitamin K during pregnancy is beyond
the scope of this review
Disclaimer
 Medicines Q&As are intended for healthcare professionals and reflect UK practice.
 Each Q&A relates only to the clinical scenario described.
 Q&As are believed to accurately reflect the medical literature at the time of writing.
 The authors of Medicines Q&As are not responsible for the content of external websites and
links are made available solely to indicate their potential usefulness to users of NeLM. You
must use your judgement to determine the accuracy and relevance of the information they
contain.
 See www.ukmi.nhs.uk/activities/medicinesQAs/default.asp for full disclaimer.
From the NHS Evidence website www.evidence.nhs.uk
2
Medicines Q&As
References
1. The Royal College of Obstetricians and Gynaecologists. Green-top guideline No. 43.
Obstetric cholestasis. April 2011 Accessed 24/07/12 via http://www.rcog.org.uk/files/rcogcorp/GTG43obstetriccholestasis.pdf
2. British National Formulary (BNF). Edition 63. March 2012. Accessed 24/07/12 via
http://bnf.org/bnf/
3. UK Teratology Information Service formerly known as the National Teratology Information
Service. Treatment of obstetric cholestasis in pregnancy. 2009. Accessed 24/07/12 via
http://www.toxbase.org/Specialist-areas/Exposure-in-pregnancy/
4. Saleh MM and Abdo KR. Intrahepatic cholestasis of pregnancy. Journal of Women’s Health
2007; 16: 833-841.
5. Saleh MM, Abdo KR. Consensus on the management of obstetric cholestasis: National UK
Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114: 99-103.
6. Fiadjoe PK and Overton C. Consensus on the management of obstetric cholestasis: National
UK Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114: 656.
7. Memtsa M, Pun S, West P et al. Consensus on the management of obstetric cholestasis:
National UK Survey. BJOG: An International Journal of Obstetrics & Gynaecology 2007; 114:
910-911.
Quality Assurance
Prepared by
Richard Leung (based on earlier work by Emma Shepherd), Medicines Information Pharmacist, South
West Medicines Information and Training, University Hospitals Bristol NHS Foundation Trust
Date Prepared
15th September 2010
Updated 24th July 2012
Checked by
Julia Kuczynska, Senior MI Pharmacist, South West Medicines Information and Training, University
Hospitals Bristol NHS Foundation Trust
Date of check
3rd August 2012
Search strategy




Embase: (OBSTETRIC CHOLESTASIS)
Medline: (Obstetric and Cholestasis)
NELM: (cholestasis and pregnancy) (Vitamin K and pregnancy)
Google Scholar: (obstetric cholestasis and vitamin K)
From the NHS Evidence website www.evidence.nhs.uk
3