Hydroxychloroquine does little to prevent recurrent miscarriage

Treatment with hydroxychloroquine does not appear to improve the chances of livebirth for women with a history of three consecutive miscarriages, according to a phase III study.

The study was conducted in France and included 167 women aged 18–38 years with at least three previous unexplained first-trimester miscarriages (normal parental karyotypes and no uterine cavity abnormality). These participants were randomly assigned to receive hydroxychloroquine 400 mg or matched oral placebo, administered orally every day. Treatment was initiated before conception and stopped at 10 weeks of gestation.

A total of 125 (75 percent) conceived, among whom 74 (59 percent) delivered successfully. Livebirth rates were 58 percent among participants who received hydroxychloroquine and 61 percent among those who received placebo, for an absolute difference of –3 percent (95 percent confidence interval [CI], –19.5 to 14.1).

Compared with placebo, hydroxychloroquine had no significant effect on the odds of livebirth (odds ratio, 0.89, 95 percent CI, 0.43–1.81; p=0.49).

The study was terminated after two cases of polydactyly occurring in the hydroxychloroquine group. However, the incidence of infant or foetus adverse events was similar between the hydroxychloroquine and placebo groups. These events included one medical termination of pregnancy and one urinary malformation in both groups, two cases of polydactyly in the hydroxychloroquine group, and a muscular interventricular communication in the placebo group.

There were no reports of maternal or infant deaths, and the two intrauterine foetal deaths documented were unrelated to hydroxychloroquine.

The findings do not support the routine prescription of hydroxychloroquine for preventing recurrent miscarriages.