This handout is for intrahepatic cholestasis of pregnancy (icp). Your care team identified this based on: pruritus (especially palms and soles, worse at night, often without rash) in second/third trimester — gateway symptom (smfm consult #53 lee 2021 pmid 33197417).
Other reasons your team may use this plan: non-fasting serum total bile acids ≥ 10 µmol/l in symptomatic pregnant patient — defining laboratory criterion (smfm 2021 pmid 33197417); mild-to-moderate ast/alt elevation (typically < 5x uln) in second/third trimester pregnancy with pruritus — supports icp (glantz 2004 pmid 15368452); new jaundice in third trimester pregnancy — uncommon icp presentation; mandates broader hepatic ddx (viral hepatitis, aflp, hellp) and immediate workup.
Take these medications exactly as prescribed. Do not stop or change a dose without talking to your provider.
| Medication | Starting dose | How | When | What it does |
|---|---|---|---|---|
| ursodiol | 10-15 mg/kg/day PO divided BID-TID (typical 300 mg PO BID-TID for 60 kg patient) | PO | BID-TID | PregCat: former B — broad clinical experience in 2nd/3rd trimester ICP without safety signal; LactMed-checked. | Lactation: compatible — LactMed notes minimal transfer into breast milk and considered compatible with breastfeeding. | First-line for maternal SYMPTOM relief per SMFM Consult #53 Lee 2021 (PMID 33197417, GRADE 1A); PITCHES RCT (PMID 31378395) showed UDCA does NOT reduce adverse perinatal composite (RR 0.85, 95% CI 0.62-1.15) so counsel maternal pruritus-relief indication only, not fetal-protective; titrate to symptom response over 1-2 weeks. |
| diphenhydramine | 25-50 mg PO q6h PRN pruritus | PO | q6h PRN | PregCat: former B — extensive pregnancy exposure data without teratogenic signal. | Lactation: compatible with caution per LactMed — small amounts in breast milk; may cause infant sedation or reduce milk supply with prolonged high-dose use; occasional doses generally acceptable. | Adjunct PRN pruritus relief when UDCA insufficient; nocturnal dosing exploits sedation effect to improve sleep disrupted by ICP pruritus. |
| hydroxyzine | 25 mg PO q6-8h PRN pruritus | PO | q6-8h PRN | PregCat: former C — animal teratogenicity at supratherapeutic doses; human data limited but no clear teratogenic signal; cautious clinical use throughout pregnancy. | Lactation: limited-data per LactMed — small amounts likely in milk; cautious use; observe infant for sedation. | Second-line antihistamine for refractory ICP pruritus; longer half-life than diphenhydramine; preferred for daytime pruritus when sedation is acceptable. |
| phytonadione | 10 mg PO daily (or 1-10 mg SC if oral malabsorption) | PO/SC | daily until delivery | PregCat: former C — labeling categorises as C but used commonly throughout pregnancy when indicated; benefit-risk overwhelmingly favors use when coagulopathy present. | Lactation: compatible per LactMed — vitamin K is routinely given to newborns at birth and small amounts in milk are insufficient for newborn vitamin K stores anyway; no maternal concern. | Replaces vitamin-K-dependent factors depleted by prolonged cholestasis; reduces PPH risk; PT/INR recheck after 24-48 h; not needed if PT normal. |
| topical emollients and cooling agents | — | — | — | PregCat: N/A — topical non-pharm; FDA labeling does not assign for emollients/menthol-based topicals. | Lactation: compatible — topical only, no systemic absorption concern. | Adjunctive non-pharm: emollient creams, colloidal oatmeal baths, cool compresses, light cotton clothing; first-line behavioral measures before escalating pharm therapy and continued throughout treatment. |
| delivery at 36+0 weeks gestation | — | — | — | PregCat: N/A — obstetric decision, not a drug. | Lactation: N/A — delivery event. | SMFM Consult #53 Lee 2021 (PMID 33197417) GRADE 1B — bile acids ≥ 100 µmol/L stratifies to highest stillbirth risk tier (HR 30.5 per Ovadia 2019 IPD meta-analysis PMID 30773280); delivery at 36+0 wk balances stillbirth risk against neonatal morbidity of preterm delivery. |
| delivery at 36+0 to 39+0 weeks gestation | — | — | — | PregCat: N/A — obstetric decision. | Lactation: N/A. | SMFM Consult #53 Lee 2021 (PMID 33197417) GRADE 1C — bile acids < 100 µmol/L (intermediate or low tier per Ovadia 2019 PMID 30773280) supports delivery 36+0 to 39+0 wk individualised by tier (40-99 favors earlier within window; < 40 typically 39+0). |
| antenatal corticosteroids for fetal lung maturity | — | — | — | PregCat: N/A — administered for fetal benefit; per SMFM 2021 (PMID 33197417) GRADE 1A. | Lactation: N/A — single course before delivery. | Betamethasone 12 mg IM q24h x 2 doses (or dexamethasone 6 mg IM q12h x 4 doses) per ALPS framework via ob.preterm-labor.v1 if delivery anticipated < 37 wk and no prior course; reduces neonatal respiratory morbidity. |
Plan: ICP pruritus management + delivery timing — UDCA first-line for maternal symptoms (SMFM Consult #53 Lee 2021 PMID 33197417 GRADE 1A; PITCHES RCT Chappell 2019 Lancet PMID 31378395 — no fetal benefit) + adjunctive antihistamines + vitamin K if coagulopathy + bile-acid-tiered delivery (Ovadia 2019 IPD meta-analysis PMID 30773280)
Contact your care team if any of the following happen:
Call 911 or go to the nearest emergency room right away if you have:
Symptoms typically resolve within days to a few weeks postpartum; bile acids + LFTs normalise within 4-8 wk. Persistent biochemical abnormalities > 3 mo postpartum → outpatient hepatology referral (rule out underlying PBC, PSC, hepatitis B/C, autoimmune hepatitis). Counsel ~ 60-90% recurrence in subsequent pregnancies + early presentation in any future pregnancy with pruritus. Estrogen-containing contraception relative caution (can re-trigger cholestasis; progestin-only or non-hormonal preferred until biochem normalised). Mental-health screen (EPDS) — chronic pruritus + stillbirth fear carries psychological burden.
Guideline: SMFM Consult Series #53 (2021) Intrahepatic Cholestasis of Pregnancy + Ovadia 2019 IPD meta-analysis (Lancet) + PITCHES 2019 RCT (Lancet) + Glantz 2004 Hepatology + Ch'ng 2002 Gut + LactMed for ursodiol / diphenhydramine / hydroxyzine / phytonadione