ACOG session offers updates, recommendations for drugs to prevent recurrent preterm birth

Key takeaways:

• Hydroxyprogesterone caproate is not recommended to prevent recurrent preterm birth.
• Vaginal progesterone may be a treatment option but should not be considered as an alternative to hydroxyprogesterone caproate.

BALTIMORE — A late-breaking session at the ACOG Annual Clinical & Scientific Meeting reviewed the FDA approval and withdrawal of 17-hydroxyprogesterone caproate injection and alternatives to prevent recurrent preterm birth.

Mark Allen Turrentine, MD, FACOG, chair of the ACOG Clinical Consensus-Obstetrics Committee and professor of obstetrics and gynecology at Baylor College of Medicine, discussed the updated guidance for administering 17-hydroxyprogesterone caproate (17-OHPC; Makena, Covis Pharma) to prevent recurrent preterm birth and some key takeaways that clinicians should be knowledgeable of today.

In 2003, 17-OHPC was first published as a possible treatment for the prevention of recurrent preterm birth in The New England Journal of Medicine and was broadly recommended by ACOG and the Society for Maternal-Fetal Medicine for patients with a history of preterm birth. This drug was then approved in 2011, but in January 2020, a multinational randomized controlled trial, the PROLONG trial, showed no benefit with 17-OHPC in preventing recurrent preterm birth. In October 2020, the FDA recommended the approval withdrawal of 17-OHPC, and despite an appeal from the manufacturer and hearings, the FDA withdrew the approval of 17-OHPC in April 2023.

“The FDA in assessment of the current body of evidence concluded that there were not sufficient data to indicate that this was effective treatment in the broad population, as it was originally approved for all pregnant women with a prior spontaneous preterm birth between 20 and 37 weeks of gestation,” Turrentine said during the session. “Whether this intervention would be useful in a subset of people requires future study.”

Take-home messages

• Current evidence does not support 17-OHPC as primary prevention for preterm birth among patients with a history of spontaneous preterm birth.
• Vaginal progesterone may be a treatment option for patients with preterm birth history, singleton gestation and a shortened cervix.
• Evidence does not support vaginal progesterone as an alternative to 17-OHPC in preventing recurrent preterm birth for women with singleton pregnancies without prior preterm birth from 20- to 37-weeks’ gestation and without a shortened cervix.
• Patients with singleton pregnancies and prior preterm birth should be assessed with vaginal ultrasound and cervical measurement, and interventions should be chosen depending on cervix length, prior pregnancy history and past treatment.

Healio previously covered the FDA approval withdrawal of 17-OHPC due to lack of clinical benefit in April 2023.