|
1 Indications And Usage Hydroxyprogesterone Caproate 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 Hydroxyprogesterone Caproate Injection 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 Hydroxyprogesterone Caproate Injection 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. Hydroxyprogesterone Caproate 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 Hydroxyprogesterone Caproate 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: Hydroxyprogesterone Caproate Injection Is Not Intended For Use In Women With Multiple Gestations Or Other Risk Factors For Preterm Birth. (1)
|