Meta AnalysisID 1533
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
CRD42017056590
To determine the diagnostic accuracy of total serum bile acids or total serum bile acids profiles, or both for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women presenting with pruritus. To compare
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Record Fields
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- Meta Analysis Id
- 1533
- Evidence Id
- 10091
- Core Evidence Id
- 10091
- Source Meta Analysis Id
- 1489
- Herb2 Meta Analysis Id
- HBMA001489
- Crd Id
- CRD42017056590
- Title
- Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy
- Review Question
- To determine the diagnostic accuracy of total serum bile acids or total serum bile acids profiles, or both for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women presenting with pruritus. To compare the diagnostic accuracy of total serum bile acids and each component of serum bile acid profiles, 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.
- 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.
- Condition Being Studied
- Intrahepatic cholestasis of pregnancy (also known as obstetric cholestasis) is a pregnancy-specific liver disorder, that is possibly associated with an increased risk of severe fetal adverse events.
- Participant
- Pregnant women of any age or ethnicity, recruited in any clinical setting.
- Animal
- Human Disease Modelled
- Intervention
- Intrahepatic cholestasis of pregnancy is defined as pruritus with onset during pregnancy associated with abnormal liver tests, both unexplained by other skin or liver diseases, and which resolves after delivery. We will calculate the accuracy of the following index tests, singly or in combination (i.e. TSBAs plus any component of serum bile acid profile) for the diagnosis of intrahepatic cholestasis of pregnancy: 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).
- Comparator Control
- The reference standard for diagnosis is considered to be the clinical evaluation in which follow-up after delivery is included. In particular, clinical evaluation is 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.
- Main Outcome
- 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.
- Outcome Measure
- Additional Outcome
- 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.
- Study Method
- Systematic review
- Keyword
- Bile; Bile Acids and Salts; Cholestasis, Intrahepatic; Diagnostic Techniques, Obstetrical and Gynecological; Female; Humans; Maternal Health; Pregnancy; Pregnancy Complications; Pregnancy Outcome
- Contact
- Cristina Manzotti [email protected]
- Organisational Affiliation
- Cochrane Hepato-Biliary Group
- Funding Source
- Cochrane Hepato-Biliary Group (CPH)
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Italy
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2017-02-03
- Anticipated Start Date
- 2015-10-01
- Anticipated Completion Date
- 2017-12-01
- 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
- Title En
- Total serum bile acids or serum bile acid profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy
- Bilingual Status
- complete