SummaryBackgroundIntrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy.MethodsWe did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal death after randomisation or known neonatal death up to 7 days after birth), preterm delivery (<37 weeks' gestation), or neonatal unit admission for at least 4 h (from birth until hospital discharge). Each infant was counted once within this composite. All analyses were done according to the intention-to-treat principle. The trial was prospectively registered with the ISRCTN registry, number 91918806.FindingsBetween Dec 23, 2015, and Aug 7, 2018, 605 women were enrolled and randomly allocated to receive ursodeoxycholic acid (n=305) or placebo (n=300). The primary outcome analysis included 304 women and 322 infants in the ursodeoxycholic acid group, and 300 women and 318 infants in the placebo group (consent to use data was withdrawn for 1 woman and 2 infants). The primary composite outcome occurred in 74 (23%) of 322 infants in the ursodeoxycholic acid group and 85 (27%) of 318 infants in the placebo group (adjusted risk ratio 0·85 [95% CI 0·62–1·15]). Two serious adverse events were reported in the ursodeoxycholic acid group and six serious adverse events were reported in the placebo group; no serious adverse events were regarded as being related to treatment.InterpretationTreatment with ursodeoxycholic acid does not reduce adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. Therefore, its routine use for this condition should be reconsidered.FundingNational Institute for Health Research Efficacy and Mechanism Evaluation Programme.

What are the novel findings of this work? Preterm delivery occurred in a higher proportion of women with SARS-CoV-2 infection in the PAN-COVID and AAP-SONPM registries compared to contemporaneous and historical national data from uninfected women in the UK and USA. The majority of preterm deliveries occurred between 32 + 0 and 36 + 6 weeks' gestation. SARS-CoV-2 infection in pregnancy did not appear to be associated with a clinically significant effect on fetal growth, adverse neonatal outcome or the rate of stillbirth. Although maternal death was uncommon, the rate was higher than expected based on UK and USA population data, which is likely explained by underascertainment of women affected by milder or asymptomatic infection in pregnancy in the PAN-COVID study, although not in the AAP-SONPM study. What are the clinical implications of this work? Pregnant women should be counseled that SARS-CoV-2 infection increases the risk of preterm delivery but not stillbirth, early neonatal death or a small baby. Healthcare providers should recommend SARS-CoV-2 vaccination in pregnant women and women planning pregnancy, alongside enhanced social distancing.

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Arrhythmias are one of the most common forms of cardiac disease presenting in pregnancy. Women with underlying arrhythmias may only present to health care professionals when they are pregnant. The most common type of sustained arrhythmia presenting in pregnancy is a supraventricular tachycardia (SVT). This can be difficult to diagnose, as symptoms such as palpitations, dizziness and shortness of breath are also common symptoms of pregnancy. We present the management of a woman who developed intrapartum SVT. Her case highlights the importance of considering the diagnosis in the antenatal period, the use of antiarrhythmic drugs, as well as the fact that achieving vaginal delivery is possible in correctly selected cases while the mother and baby remain stable.

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