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Updated: Nov 8, 2025
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Next generation strategies for preventing preterm birth
Hannah C Zierden1, Rachel L Shapiro1, Kevin DeLong2
1Center for Nanomedicine at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA; Department of Chemical & Biomolecular Engineering, Johns Hopkins University, Baltimore, MD 21218, USA.
Insights
Preterm birth prevention faces challenges as Makena may lose FDA approval. New interdisciplinary research aims to identify risks and develop novel therapies to save infant lives.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Biomedical Engineering
Background:
- Preterm birth (PTB) affects 15 million infants globally, increasing mortality and lifelong health issues.
- The U.S. currently has limited FDA-approved therapies for PTB prevention, with Makena facing potential withdrawal.
- Lack of effective treatments necessitates urgent development of new therapeutic options.
Purpose of the Study:
- To address the critical need for effective preterm birth prevention strategies.
- To explore interdisciplinary approaches for understanding PTB.
- To develop next-generation therapies for preventing premature labor.
Main Methods:
- Interdisciplinary collaboration involving physicians, pharmacologists, biologists, chemists, and engineers.
- Investigating risk factors and underlying mechanisms of preterm birth.
- Developing novel therapeutic interventions for PTB prevention.
Main Results:
- Advances in understanding PTB risk factors and mechanisms.
- Development of potential next-generation therapies.
- Improved identification of at-risk pregnancies.
Conclusions:
- Interdisciplinary research is crucial for advancing PTB prevention.
- Novel therapies hold promise for reducing premature labor onset.
- These efforts aim to significantly decrease infant mortality and improve outcomes.
Abstract:
Preterm birth (PTB) is defined as delivery before 37 weeks of gestation. Globally, 15 million infants are born prematurely, putting these children at an increased risk of mortality and lifelong health challenges. Currently in the U.S., there is only one FDA approved therapy for the prevention of preterm birth. Makena is an intramuscular progestin injection given to women who have experienced a premature delivery in the past. Recently, however, Makena failed a confirmatory trial, resulting the Center for Drug Evaluation and Research's (CDER) recommendation for the FDA to withdrawal Makena's approval. This recommendation would leave clinicians with no therapeutic options for preventing PTB. Here, we outline recent interdisciplinary efforts involving physicians, pharmacologists, biologists, chemists, and engineers to understand risk factors associated with PTB, to define mechanisms that contribute to PTB, and to develop next generation therapies for preventing PTB. These advances have the potential to better identify women at risk for PTB, prevent the onset of premature labor, and, ultimately, save infant lives.
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