Challenges in Using Progestin to Prevent Singleton Preterm Births: Current Knowledge and Clinical Advice.

Area of Science:

• Obstetrics and Gynecology
• Perinatal Medicine
• Pharmacology

Background:

• Preterm birth is a major global cause of infant mortality.
• Progestogen therapy for preterm birth prevention is controversial.
• 17-alpha-hydroxyprogesterone caproate (17OHP-C) is a synthetic progestin previously used to prevent recurrent preterm birth.

Purpose of the Study:

• To review the historical context of 17OHP-C use in preventing preterm birth.
• To analyze the challenges and limitations of data supporting progestogen efficacy.
• To discuss future directions for impacting preterm birth rates.

Main Methods:

• Review of existing literature and clinical trial data on progestogen therapy.
• Analysis of FDA decisions and regulatory actions regarding 17OHP-C.
• Synthesis of evidence regarding different progestogen formulations and patient populations.

Main Results:

• The US FDA has withdrawn accelerated approval for 17OHP-C.
• There is currently no FDA-approved treatment for spontaneous preterm birth prevention.
• Evidence supporting progestogen use varies significantly by formulation and study population.

Conclusions:

• The withdrawal of 17OHP-C highlights the complexities and controversies in preterm birth prevention.
• Further research is needed to identify effective and safe interventions.
• Addressing preterm birth requires a multifaceted approach beyond current progestogen therapies.