The results of the PROLONG Study (Progestin’s Role in Optimizing Neonatal Gestation) are now available. The authors conclude that
In this study population, 250 mg 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death
On October 29, 2019, the FDA advisory committee recommended that the drug be withdrawn from the market (9 to 7 vote). Although the recommendation is not binding, it does become part of the overall assessment process when the FDA makes its final decision.
SMFM has responded to the PROLONG trial results and makes the following substantive points comparing current data to Meis et. al. study
…it is reasonable for providers to use 17-OHPC in women with a profile more representative of the very high-risk population reported in the Meis trial. For all women at risk of recurrent sPTB, the risk/benefit discussion should incorporate a shared decision-making approach, taking into account the lack of short-term safety concerns but uncertainty regarding benefit
ACOG has likewise responded to the PROLONG trial with a Practice Advisory
A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16–24 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth
is not changing our clinical recommendations at this time and continues to recommend offering hydroxyprogesterone caproate as outlined in Practice Bulletin # 130
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