![]() ![]() It would be detrimental to high-risk pregnant patients to inappropriately prioritize results of PROLONG over the Maternal-Fetal Medicine Units Network’s Meis trial (funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development). Given that the United States has among the highest preterm birth rates in the world and that the predominant enrollment in PROLONG was outside the United States, the results of the “old” Meis trial should not be summarily dismissed. The Meis trial was rigorously designed and conducted, with highly statistically significant results that should not be undermined by the negative results of PROLONG. The recent PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial failed to confirm the original findings. This commentary reviews the original landmark Meis trial (“Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate”), which led to conditional approval of 17α-hydroxyprogesterone caproate by the FDA in 2011. Food and Drug Administration (FDA)–approved 17α-hydroxyprogesterone caproate therapy is currently available to reduce recurrent preterm birth in the United States. The work cannot be changed in any way or used commercially without permission from the journal. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. Peer reviews and author correspondence are available at. The authors thank AMAG Pharmaceuticals Inc employees Jennifer Gudeman and Paula Moon-Massat for reviewing the manuscript for accuracy regarding the FDA application and data.Įach author has confirmed compliance with the journal's requirements for authorship. Das disclosed receiving funds from AMAG Pharmaceuticals and that she is a consultant for Hologic. Saade disclosed that he received payments from AMAG for travel reimbursement as well as advisory board and consultation fees. Sibai disclosed that he received payments from AMAG for travel reimbursement as well as consultation fees for the FDA Advisory Committee meeting. Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, Houston, and the Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, Texas and Das Consulting, Guerneville, California.Ĭorresponding author: Baha Sibai, MD, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, Houston, TX email. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |