The international e-Delphi and consensus process has successfully defined a Core Outcome Set ICP. This set standardizes the minimum outcomes that researchers must report in all studies of Intrahepatic Cholestasis of Pregnancy (ICP). Consequently, this standardization aims to reduce outcome reporting bias and research wastage. The consensus involved 155 international stakeholders, including patients, clinicians, and researchers, ensuring a broad and relevant perspective.
The Critical Need for Standardized Reporting
Previously, researchers reported 97 individual clinical outcomes across 54 manuscripts, demonstrating significant outcome heterogeneity. Such variability makes combining and comparing study results difficult, limiting the power of meta-analyses. Therefore, the Core Outcome Set (COS) establishes a common framework, ensuring consistency and comparability across trials. Notably, the rigorous process followed Core Outcome Measures in Effectiveness Trials (COMET) Initiative guidelines. The goal is to maximize the utility of all research efforts.
Core Outcome Set ICP Components
The e-Delphi survey short-listed 23 outcomes. Following the consensus meetings, the stakeholders selected 10 essential outcomes for the Core Outcome Set. The final set covers three critical domains.
Maternal core outcomes focus on key diagnostic and symptom metrics. These outcomes are: total maternal bile acid (BA) concentration (maximum), gestational age at peak BA concentration, and itch impact on maternal wellbeing.
Birth core outcomes capture immediate delivery consequences. Specifically, they include stillbirth, gestational age at birth, and spontaneous preterm birth versus induced preterm birth.
Neonatal core outcomes measure the severity of perinatal complications. Furthermore, these comprise perinatal death within 7 days of birth, perinatal asphyxia, neonatal unit admission, and mechanical ventilation.
ICP Management in the Indian Context
Intrahepatic Cholestasis of Pregnancy affects a significant population in India. Prevalence rates are reported around 4%. Consequently, this Core Outcome Set holds particular importance for improving local research quality. Indian studies demonstrate that Serum Bile Acids (SBA) are generally higher in Asian Indian pregnant women. For instance, clinicians may recommend a BA cut-off greater than 30 µmol/L for diagnosis. This specific local data highlights the clinical significance of the core outcomes related to maternal BA concentration and gestational age at birth. Ultimately, using the COS helps ensure that all future studies produce comparable and reliable data for clinical guidelines.
Frequently Asked Questions
Q1: What is the Core Outcome Set (COS) for ICP?
It is a minimum set of 10 outcomes that must be measured and reported in all studies related to Intrahepatic Cholestasis of Pregnancy. It standardizes research reporting worldwide.
Q2: What are the three main maternal core outcomes?
The maternal outcomes are: total maternal bile acid concentration (maximum), gestational age at peak bile acid concentration, and itch impact on maternal wellbeing.
Q3: Who developed the COS for ICP?
An international group of 155 stakeholders, including patients, clinicians, and researchers from around the world, developed the COS through an e-Delphi survey and consensus process.
References
- Capatina N et al. A Core Outcome Set for Studies of Intrahepatic Cholestasis of Pregnancy: Results of International e-Delphi and Consensus Processes. BJOG. 2026 Jan 09. doi: 10.1111/1471-0528.70144. PMID: 41513274.
- Designing a core outcome set for studies of Intrahepatic Cholestasis of Pregnancy. COMET Initiative.
- Agarwal N et al. Serum Bile Acids in Intrahepatic Cholestasis of Pregnancy (ICP), Versus Pregnant and Nonpregnant Controls in Asian Indian Women and a Proposed Scoring to Optimize Management in ICP. J Obstet Gynaecol India. 2016;66(Suppl 1):175-183.
- Yadav P et al. Maternal and fetal outcome in intrahepatic cholestasis of pregnancy at tertiary care institute of North India. Indian J Med Sci. 2021;73(3):328-333.