Roberto Jose Romero-Galue, D(Med)Sc,M.D.

Senior Investigator

Pregnancy Research Branch

NICHD/DIR

Building 29B
Room: 1H16D
Bethesda, MD 20892

313-330-9978

romeror@mail.nih.gov

Research Topics

Premature birth remains the leading cause of perinatal morbidity and mortality worldwide. The Pregnancy Research Branch (PRB) has conceptualized preterm labor as a syndrome arising from multiple interacting biological pathways rather than a single disease entity. One important mechanism contributing to spontaneous preterm birth is an untimely decline in progesterone action, which is clinically manifested by silent shortening of the uterine cervix. Seminal work by the PRB demonstrated that asymptomatic women with a second-trimester cervical length of 15 mm or less have approximately a 50 percent risk of early preterm delivery. Recognizing that prediction must be coupled with prevention, the PRB conducted a large prospective randomized clinical trial across 44 centers worldwide demonstrating that vaginal progesterone administration to women with a short cervix results in a substantial reduction in preterm birth and neonatal morbidity. These findings provided the scientific basis for universal cervical length screening and targeted progesterone therapy, an approach estimated to yield substantial health care savings while improving neonatal outcomes.

Beyond preterm birth, the PRB has focused on the major complications of pregnancy responsible for maternal and perinatal morbidity and mortality, including preeclampsia, maternal infection and clinical chorioamnionitis, postpartum hemorrhage, fetal death, amniotic fluid embolism, which is one of the leading causes of maternal death on the day of delivery, and fetal growth disorders. To provide a unifying biological and clinical framework, the PRB coined the term Great Obstetrical Syndromes, emphasizing shared mechanisms, overlapping pathways, and common opportunities for prediction, treatment, and prevention across these conditions. The PRB also introduced the concept of the Fetal Inflammatory Response Syndrome, defining a pathophysiologic link between intrauterine inflammation, fetal organ injury, and adverse short- and long-term outcomes. Complementing this mechanistic work, the PRB has advanced prenatal diagnosis through the development and application of three- and four-dimensional ultrasound technologies and novel computational approaches, particularly for the early detection of congenital anomalies such as congenital heart disease. Collectively, this integrated research program seeks to elucidate the biology of pregnancy complications and translate discovery into improved strategies for maternal and infant health.

Biography

Dr. Roberto Romero is Chief of the Pregnancy Research Branch (PRB) and Head of the Program for Perinatal Research and Obstetrics in the Division of Intramural Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Established by Public Law, the PRB is devoted to the study of pregnancy and its complications through integrated clinical, translational, and mechanistic research. Dr. Romero trained in Obstetrics and Gynecology at Yale University and completed fellowship training in Maternal-Fetal Medicine. Over the course of his career, his research has focused on the mechanisms, diagnosis, and prevention of major obstetric syndromes, including spontaneous preterm birth, preeclampsia, fetal growth restriction, fetal death, and inflammatory disorders of pregnancy. His work integrates maternal–fetal medicine, neonatology, placental pathology, epidemiology, immunology, microbiology, advanced imaging, and high-dimensional biology, including genomics, proteomics, and computational approaches.

Dr. Romero is the author of more than 1,300 peer-reviewed publications and is among the most highly cited physician–scientists in medicine, with an H-index of 203 and more than 191,000 citations, including over 68,000 since 2020. Independent analyses place him in the top 0.01% of scientists worldwide across multiple fields, and he ranks first in scholarly impact within NICHD. His research has directly shaped clinical practice and professional guidelines, including landmark randomized trials demonstrating that vaginal progesterone reduces spontaneous preterm birth and neonatal morbidity, as well as the development of rapid diagnostic approaches for intraamniotic infection and inflammation. In 2025, his work resulted in the award of two U.S. patents to the NIH. Dr. Romero maintains active collaborations across intramural and extramural programs, including partnerships with INOVA, UCSF, Rockefeller University, Wayne State University, and George Washington University, where he is engaged in teaching and mentoring. He serves as Editor-in-Chief for Obstetrics of the American Journal of Obstetrics & Gynecology, chairs major national and international scientific meetings, and was appointed co-leader of a National Academy of Medicine forum on cesarean delivery. His contributions have been recognized with numerous national and international honors, including membership in the National Academy of Medicine, multiple lifetime achievement awards, and honorary doctorates from universities worldwide.

Selected Publications

  1. Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW, PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011;38(1):18-31.
  2. Garcia-Flores V, Romero R, Tarca AL, Peyvandipour A, Xu Y, Galaz J, Miller D, Chaiworapongsa T, Chaemsaithong P, Berry SM, Awonuga AO, Bryant DR, Pique-Regi R, Gomez-Lopez N. Deciphering maternal-fetal cross-talk in the human placenta during parturition using single-cell RNA sequencing. Sci Transl Med. 2024;16(729):eadh8335.
  3. Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014;345(6198):760-5.
  4. Hamilton EF, Zhoroev T, Warrick PA, Tarca AL, Garite TJ, Caughey AB, Melillo J, Prasad M, Neilson D, Singson P, McKay K, Romero R. New labor curves of dilation and station to improve the accuracy of predicting labor progress. Am J Obstet Gynecol. 2024;231(1):1-18.
  5. Garcia-Flores V, Romero R, Peyvandipour A, Galaz J, Pusod E, Panaitescu B, Miller D, Xu Y, Tao L, Liu Z, Tarca AL, Pique-Regi R, Gomez-Lopez N. A single-cell atlas of murine reproductive tissues during preterm labor. Cell Rep. 2023;42(1):111846.

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This page was last updated on Monday, January 19, 2026