Evidence of benefit in reducing preterm birth before 34 weeks was more certain for vaginal progesterone, but there was no clear evidence that either vaginal progesterone or 17-OHPC was superior
A consistent direction of benefit was noted for other birth and neonatal outcomes, including preterm birth before 28 weeks, preterm birth before 37 weeks, perinatal mortality, and composite serious neonatal complications
Patients with a singleton pregnancy and a prior spontaneous preterm birth should be offered progesterone supplementation (either vaginal or intramuscular) in the context of a shared-decision making process with the patient incorporating the available evidence and the patient’s preferences
With regard to multiple gestations, the Evaluating Progestogens for Preventing Preterm Birth International Collaborative (EPPPIC) findings support the current recommendation that progesterone supplementation is not indicated for the indication of multiple gestation alone as there is no evidence of benefit
The EPPPIC meta-analysis grouped together HPC trials of patients with differences in their risk profiles, including combining women with a prior PTB and those without a prior PTB, and women with and without a short cervix
Because of this grouping, the meta-analysis does not provide relevant information regarding Makena’s effectiveness for its approved use. CDER continues to conclude the available data have not shown Makena is effective for reducing morbidity or mortality in newborns or for the prevention of recurrent PTB in women with a prior spontaneous PTB
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