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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

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Abstract

Objectives

This prospective clinical trial was conducted to assess serum bile acids (BA) levels in women with intrahepatic cholestasis of pregnancy (ICP) compared to both pregnant and non-pregnant controls; and evaluate perinatal outcome in relation to bile acid levels. A scoring is proposed based on biochemical markers to optimize management in ICP cases.

Materials and Methods

Serum bile-acids(BA) were assessed in 71 intrahepatic-cholestasis of pregnancy(ICP) cases (group-I), versus 50 pregnant (group-II) and 35 non-pregnant (group-III) controls. Ursodeoxycholic acid (UDCA) was administered in ICP group. Baseline bilirubin (SB), aminotransferases (AT), alkaline-phosphatase were sent in groups I & II. Investigations were repeated in group-I after 4 weeks. Perinatal complications were noted.

Results

Mean BA in group-I was 75.92 ± 39.9 µmol/L which reduced to 41.3 ± 15.4 µmol/L(45.6%, p < 0.001) with UDCA. Mean BA was 29.2 ± 5.7 and 5.9 ± 1.8 µmol/L in group-II and group-III. UDCA significantly reduced itching-score. Rate of fetal distress linearly increased with the increasing baseline levels of serum BA, AT and SB: from 2.5 to 100% at BA < 40 and ≥ 200 µmol/L, (p = 0.008); from 16.1 to 100% at AT < 100 and ≥ 500 IU/mL(p = 0.016); and from 6.8 to 100% at SB < 0.8 and > 5 mg/dL (p = 0.001); respectively. Their baseline levels were divided into 5 groups in correlation to fetal distress. Serum BA < 40, 40–80, 80–120, 120–200, ≥ 200 µmol/L; AT < 100,100–200,200–500, ≥ 500 IU/mL; and SB < 0.8, 0.8–1.0, 1.1–2, 2.1–5 and > 5 mg/dL. Nutan ICP scoring was proposed with a score 0 to 4 given to each parameter and score-based management protocol was suggested for fetal surveillance and delivery.

Conclusions

SBA are higher in Asian Indian pregnant women. Levels > 30 µmol/L can be taken as a cut off for diagnosing ICP in Asian-Indian women. Adopting higher cut-offs for this geographic part will avoid over-diagnosing ICP and iatrogenic early termination of pregnancy. Suggested scoring will help clinicians in optimizing the time of delivery on an individualized basis.

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Acknowledgements

The project was funded by intramural grant of the institute, All India Institute of Medical Sciences, New Delhi

Funding

Intramural grant from All India Institute of Medical Sciences, New Delhi, India.

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Author notes

  1. Nutan Agarwal (Ex-Professor) & Alka Kriplani (Ex-Professor)

    Present address: Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India

Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India

    Reeta Mahey (Additional Professor), Vidushi Kulshrestha (Associate Professor), Anoop Saraya (Professor) & Vikas Sachdev (Senior Technician)

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  1. Nutan Agarwal
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Contributions

All authors contributed in the patient management and follow-up. NA conceptualized the study. RM and VS were responsible for the acquisition of clinical data, and obtaining informed consent. NA, VK and RM were responsible for manuscript writing. NA, AK and AS had overall supervision. NA and VK were responsible for manuscript’s critical editing.

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Correspondence to Nutan Agarwal.

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Conflict of interest

None of the authors have any potential conflict of interest.

Ethical statement

Study was conducted after obtaining approval from the Institute’s Ethics Committee.

Human Participants and/or Animals

All parts of Declaration of Helsinki have been applied.

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Nutan Agarwal is an Ex-Professor in Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Reeta Mahey is an Additional Professor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi. Vidushi Kulshrestha is an Associate Professor at Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi. Alka Kriplani is an Ex-Professor in Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Anoop Saraya is a Professor in Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India. Vikas Sachdev is a Senior Technician in Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.

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Agarwal, N., Mahey, R., Kulshrestha, V. 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 Gynecol India 72, 218–224 (2022). https://doi.org/10.1007/s13224-021-01501-1

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  • DOI: https://doi.org/10.1007/s13224-021-01501-1

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