Preterm birth (PTB) is a global problem, with 15 million babies born prematurely each year, putting them at greater risk of mortality and lifelong health problems. Currently, the only approved treatment for the prevention of PTB is Makena, an intramuscular progestin injection given to women who have had a preterm birth in the past. However, recently, Makena failed a confirmatory trial, which resulted in the Center for Drug Evaluation and Research (CDER) recommending that the FDA withdraw the approval of Makena. This recommendation would leave doctors without therapeutic options to prevent PTB.In response to this challenge, interdisciplinary efforts involving doctors, pharmacists, biologists, chemists, and engineers have been made to understand the risk factors associated with PTB, the mechanisms that contribute to PTB, and to develop next-generation therapies to prevent PTB.
These advances have the potential to better identify women at risk of PTB, prevent the onset of preterm birth and, ultimately, save the lives of babies.Childbirth is a complicated process that requires biological signals that coordinate maternal cervical remodeling and uterine contraction to give birth to offspring. Successful delivery is preceded by fertilization, implantation, and development of the fetus and surrounding gestational tissues. During pregnancy, amniotic fluid surrounds and protects the developing fetus within the amnion. Early in pregnancy, the yolk sac and later the chorion and placenta participate in the maternal-fetal exchange of nutrients and waste.
The maternal cervical mucus plug forms to protect the uterus.As the end of pregnancy approaches, the cervix begins to soften and mature to prepare for the fetus to pass through the vaginal canal. It is then that contractions begin labor. During this complicated process there is a possibility of a number of complications, especially when delivery occurs early.Clinically, progesterone is the only treatment approved by the FDA for the prevention of PTB; however, based on historical trials it is clear that further work must be done to understand the optimal formulation and mechanism of action of progesterone in the context of PTB. In addition to pharmaceutical trials, recent studies have investigated how diet can affect PTB rates.
The ADORE study investigated how docosahexaenoic acid (DHA) supplementation can reduce early PTB.Drug administration during pregnancy is altered due to changes in maternal physiology. These changes should be considered when considering medications, formulations, and dosing regimens for the prevention of PTB. Recent advances in nanomedicine have enabled new formulations for drug delivery that can target cells and tissues more effectively while preserving homeostasis in the vaginal environment.Future studies should continue to use rationally designed formulations that improve pharmacokinetics and pharmacodynamics of new treatments while paying special attention to safety and unwanted side effects. Through ongoing collaborative efforts, it is hoped that scientific advances will have an impact on preterm births and pregnancy outcomes.
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