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Makena not effective for reducing spontaneous preterm birth


Progesterone is administered to pregnant women in the second and third trimesters to reduce the risk of recurrent spontaneous preterm birth (sPTB), but emerging data have not confirmed the efficacy reported in earlier trials. In a multicenter international trial (PROLONG) including over 1700 women with a singleton gestation and past history of sPTB, hydroxyprogesterone caproate injections (Makena) did not reduce PTB <35 weeks compared with placebo (11.0 versus 11.5 percent). After review of these findings, a US Food and Drug Administration advisory committee recommended withdrawing approval for Makena. Some UpToDate contributors will continue to offer hydroxyprogesterone caproate with shared decision-making, while others will use intravaginal natural progesterone in patients with a history of sPTB, pending data from additional trials and revised guidance from major obstetric organizations.

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