Table 8.

Impact of management of intrahepatic cholestasis on stillbirth and perinatal mortality

Source	Location and Type of Study	Intervention	Stillbirths/Perinatal Outcomes
Intervention studies
Binder et al. 2006 [82]	Czech Republic. RCT. Singleton pregnancies (N = 78) < 36 wks with a moderate or severe form of cholestasis recruited 1999–2004.	Compared the impact among three groups [SAMe (S-adenosyl-L-methionine) monotherapy (group 1), UDCA (ursodeoxycholic acid) (group 2), and combined therapy (group 3)] on PMR.	PMR: 0/25 vs. 0/26 vs. 0/27 in groups 1, 2 and 3, respectively [NS]
Glantz et al. 2005 [83]	Sweden. Double-blind, placebo-controlled RCT. Pregnant women (N = 130; N = 47 UDCA, N = 36 dexamethasone, N = 47 placebo) with cholestasis.	Compared the impact on perinatal outcomes of treatment of cholestasis with UDCA (intervention #1), or dexamethasone (intervention #2), vs. placebo (controls).	Fetal death (miscarriage + SB): 0/47 vs. 0/36 vs. 1/47 in intervention group #1, intervention group #2, and controls, respectively.
Palma et al. 1997 [84]	Chile. Secondary case-referral center. RCT. Pregnant women (N = 15) with early-onset obstetric cholestasis.	Compared the impact on perinatal outcomes of treatment with UDCA (intervention) vs. placebo (controls).	SBR: 0/8 vs. 1/7 in intervention vs. control groups, respectively.
Roncaglia et al. 2002 [85]	Italy (Milan). University hospital. Intervention trial using prospective cases. Pregnant women (N = 218) with obstetric cholestasis and historical series data.	Compared the effect of a management protocol for cholestasis incorporating transcervical amnioscopy, standard monitoring of fetal well-being with 2× weekly non-stress testing and AFI indices, and induction of labour at 37 weeks if high-risk (intervention) vs. historical controls on obstetric outcome.	SBR: 0/218 vs. 14/888 in intervention vs. control groups, respectively (P = 0.045).