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1 Indications And Usage Makena Is A Progestin Indicated To Reduce The Risk Of Preterm Birth In Women With A Singleton Pregnancy Who Have A History Of Singleton Spontaneous Preterm Birth. The Effectiveness Of Makena Is Based On Improvement In The Proportion Of Women Who Delivered < 37 Weeks Of Gestation. There Are No Controlled Trials Demonstrating A Direct Clinical Benefit, Such As Improvement In Neonatal Mortality And Morbidity. Limitation Of Use : While There Are Many Risk Factors For Preterm Birth, Safety And Efficacy Of Makena Has Been Demonstrated Only In Women With A Prior Spontaneous Singleton Preterm Birth. It Is Not Intended For Use In Women With Multiple Gestations Or Other Risk Factors For Preterm Birth. Makena Is A Progestin Indicated To Reduce The Risk Of Preterm Birth In Women With A Singleton Pregnancy Who Have A History Of Singleton Spontaneous Preterm Birth ( 1 ). The Effectiveness Of Makena Is Based On Improvement In The Proportion Of Women Who Delivered < 37 Weeks Of Gestation ( 14 ). There Are No Controlled Trials Demonstrating A Direct Clinical Benefit, Such As Improvement In Neonatal Mortality And Morbidity. Limitation Of Use : Makena Is Not Intended For Use In Women With Multiple Gestations Or Other Risk Factors For Preterm Birth. ( 1 )
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