Meta AnalysisID 1534

血清总胆汁酸或血清胆汁酸谱，或两者联合，用于妊娠期肝内胆汁淤积症的诊断 [Cochrane方案]

CRD42017083002

To determine the diagnostic accuracy of total serum bile acids or total serum bile acids profile, or both for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women presenting with pruritus.<secondary_o

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Meta Analysis Id: 1534
Evidence Id: 10092
Core Evidence Id: 10092
Source Meta Analysis Id: 1490
Herb2 Meta Analysis Id: HBMA001490
Crd Id: CRD42017083002
Title: Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy [Cochrane protocol]
Review Question: To determine the diagnostic accuracy of total serum bile acids or total serum bile acids profile, or both for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women presenting with pruritus.<secondary_objectives modified=2017-02-02 13:09:43 +0100 modified_by=Dimitrinka Nikolova> To compare the diagnostic accuracy of total serum bile acids and each component of serum bile acid profile, considered independently or in combination, in diagnosing intrahepatic cholestasis of pregnancy; to define the optimal cut-off values for these; and to investigate possible sources of heterogeneity. </secondary_objectives>
Study Type Included: We will include prospectively or retrospectively performed diagnostic participant-control (case-control) or cross-sectional studies, irrespective of publication status or language (<link ref=REF-Colli-2014 type=REFERENCE/>Colli 2014).
Condition Being Studied: Intrahepatic cholestasis of pregnancy is a gestation-specific liver disorder, defined most often as onset of pruritus, usually from the third trimester of pregnancy, associated with abnormal liver test results or raised TSBA, or both, and spontaneous relief after delivery in the absence of other skin or liver diseases. Severe intrahepatic cholestasis of pregnancy (defined by most authors when TSBA are greater than 40 µmol/L) (<link ref=REF-Glantz-2004 type=REFERENCE/>Glantz 2004) seems to be associated with an increased proportion of serious adverse fetal outcomes which include fetal distress, sudden intrauterine death (possibly due to an acute anoxic event (<link ref=REF-Sepúlveda-1991 type=REFERENCE/>Sepúlveda 1991) or impaired fetal cardiomyocyte function (<link ref=REF-Williamson-2001 type=REFERENCE/>Williamson 2001)), preterm labour, meconium staining of amniotic fluid, low birth weight, or respiratory distress syndrome of the baby (<link ref=REF-Glantz-2004 type=REFERENCE/>Glantz 2004; <link ref=REF-Zecca-2006 type=REFERENCE/>Zecca 2006). However, one systematic review restricted to English language literature published in 2014 found that the increased risk for stillbirth, associated most often with intrahepatic cholestasis of pregnancy, might be questionable because of the scant information on how the attributable risk associated with the disease had been calculated (<link ref=REF-Henderson-2014 type=REFERENCE/>Henderson 2014). Clinical suspicion of intrahepatic cholestasis of pregnancy usually begins from the third trimester with an onset of mild-to-severe pruritus, frequently generalised on the palms and soles, getting worse at night and with advancing gestation (<link ref=REF-Kenyon-2001 type=REFERENCE/>Kenyon 2001). In severe cases, it can also affect the ears, the eyelids, and even the oral cavity (<link ref=REF-Reyes-1997 type=REFERENCE/>Reyes 1997). Pruritus in the absence of skin rash, with the exception of scratching excoriations, could be the only presenting symptom of the disease, while constitutional symptoms (insomnia, fatigue, anorexia, malaise, or abdominal pain) or typical cholestatic symptoms (jaundice, malabsorption and vitamin K deficiency, steatorrhoea, pale stools, or dark urine) are rare (<link ref=REF-Hepburn-2008 type=REFERENCE/>Hepburn 2008; <link ref=REF-Kondrackiene-2008 type=REFERENCE/>Kondrackiene 2008;<link ref=REF-Mays-2010 type=REFERENCE/>Mays 2010). Some studies describe instances of pruritus from earlier stages of pregnancy (<link ref=REF-Brites-1998b type=REFERENCE/>Brites 1998b; <link ref=REF-Keitel-2006 type=REFERENCE/>Keitel 2006; <link ref=REF-Hubschmann-2016 type=REFERENCE/>Hubschmann 2016). Onset of pruritus in late pregnancy usually directs clinicians to perform liver function tests, and rule out other possible diseases with serum or urinary markers, and imaging techniques. Despite the many available tests, an accurate and early diagnosis of intrahepatic cholestasis of pregnancy can be difficult, as it shares some of its clinical features and laboratory findings with other skin diseases (e.g. stretch marks of pregnancy; eczema; pruritic urticarial papules and plaques of pregnancy; infectious, allergic, or immunological skin disorders, etc.); liver diseases (e.g. viral and autoimmune hepatitis, tumours of hepatobiliary tract, bile stones of the biliary tree, etc.) (<link ref=REF-Diken-2014 type=REFERENCE/>Diken 2014); conditions which may lead to icterus (e.g. severe hypoglycaemia, some types of encephalopathy, disseminated intravascular coagulation, etc.); obstetric-specific benign diseases (e.g. pruritus gravidarum, defined as idiopathic onset of pruritus during pregnancy but with normal liver tests, or asymptomatic hypercholanaemia of pregnancy, defined as serum bile acids level above the upper normal limit without symptoms) (<link ref=REF-Castaño-2006 type=REFERENCE/>Castaño 2006); or also more serious diseases (e.g. pre-eclampsia, haemolysis-elevated liver enzymes-low platelet count syndrome, or acute fatty liver disease) (<link ref=REF-Bacq-2011 type=REFERENCE/>Bacq 2011). Even if most clinicians, in the least suspicion of the disease, initiate an empiric treatment with UDCA, prophylactic vitamin K, or antihistaminics (or also dexamethasone if pruritus is unbearable), the diagnosis can only be confirmed when the spontaneous relief of symptoms and signs after delivery occurs within the usual 48 hours or a few weeks later (two to four weeks), or at most eight weeks (<link ref=REF-Geenes-2009 type=REFERENCE/>Geenes 2009). In extremely rare occasions, women may have symptoms for longer periods of time (<link ref=REF-Olsson-1993 type=REFERENCE/>Olsson 1993; <link ref=REF-Aytaç-2006 type=REFERENCE/>Aytaç 2006). If the symptoms or signs, related to suspected intrahepatic cholestasis of pregnancy, do not disappear within one month, clinicians should consider other differential diagnosis; and further investigations are mandatory (<link ref=REF-Bacq-2011 type=REFERENCE/>Bacq 2011).
Participant: Pregnant women of any age or ethnicity, recruited in any clinical setting. They should have undergone the reference standard (see <link tag=CRIT_REFERENCE_STANDARDS type=SECTION/>Reference standards) and any of the index tests, singly or in combination (see <link tag=CRIT_INDEX_TESTS type=SECTION/>Index tests).
Animal
Human Disease Modelled
Intervention: We will consider the following index tests, singly or in combination (i.e. TSBAs plus any component of serum bile acid profile): total serum bile acids (TSBA); cholic acid (CA); glycocholic acid (GCA); chenodeoxycholic acid (CDCA); deoxycholic acid (DCA); lithocholic acid (LCA); ursodeoxycholic acid (UDCA); cholic/chenodeoxycholic acid ratio (CA/CDCA); total glyco-conjugated bile acids (G-c); total tauro-conjugated bile acids (T-c); total glyco-conjugated bile acids/total taurine-conjugated bile acid ratio (G-c/T-c).</ul>
Comparator Control: Reference standards Clinical evaluation in which follow-up after delivery is included. In particular, the best reference standard is clinical evaluation considered as the final judgement of the clinician who takes into account the whole clinical assessment of signs and symptoms suggestive for intrahepatic cholestasis of pregnancy; the presence of any otherwise unexplained, persistent abnormalities of aspartate transaminase (AST), alanine aminotransferase (ALT), or bilirubin levels until delivery; and follow-up after delivery assessing spontaneous relief of symptoms and normalisation of liver tests within eight weeks at most. We will judge study definitions of the reference standard to be of lower quality if any of the clinical and laboratory factors are omitted from the definitions.
Main Outcome: Diagnostic test accuracy
Outcome Measure
Additional Outcome
Study Method: Diagnostic, Systematic review
Keyword: Bile Acids and Salts; Cholestasis, Intrahepatic; Female; Humans; Intrahepatic Cholestasis of Pregnancy; Pregnancy; Pregnancy Complications
Contact: Cristina Manzotti [email protected]
Organisational Affiliation: The Cochrane Collaboration http://www.cochrane.org/
Funding Source: The Cochrane Hepato-Biliary Group
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD012546/abstract
Review Type
Language: English
Country: Italy
Review Stage: Review Ongoing
First Submission Date
Registration Date: 2017-12-02
Anticipated Start Date: 2017-02-15
Anticipated Completion Date: 2017-06-15
Title Cn: 血清总胆汁酸或血清胆汁酸谱，或两者联合，用于妊娠期肝内胆汁淤积症的诊断 [Cochrane方案]
Title En: Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy [Cochrane protocol]
Bilingual Status: complete