Am J Perinatol 2018; 35(12): 1228-1234
DOI: 10.1055/s-0038-1642062
Commentary
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

PROLONG Clinical Study Protocol: Hydroxyprogesterone Caproate to Reduce Recurrent Preterm Birth

Authors

  • Sean C. Blackwell

    1   Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas
  • Cynthia Gyamfi-Bannerman

    2   Department of Obstetrics and Gynecology, Preterm Birth Prevention Center, Columbia University Medical Center, New York, New York
  • Joseph R. Biggio Jr

    3   Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama
  • Suneet P. Chauhan

    1   Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas
  • Brenna L. Hughes

    4   Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina
  • Judette M. Louis

    5   Department of Obstetrics and Gynecology, Morsani College of Medicine, University of South Florida, Tampa, Florida
  • Tracy Manuck

    6   Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina
  • Hugh S. Miller

    7   Watching Over Mothers and Babies Foundation, Tucson, Arizona
    8   Valley Perinatal Services, Tucson, Arizona
  • Anita F. Das

    9   Das Consulting, San Francisco, California
  • Robert Birch

    10   AMAG Pharmaceuticals, Inc, Waltham, Massachusetts
  • Michael J. Jozwiakowski

    11   Department of Research and Development, AMAG Pharmaceuticals, Inc., Waltham, Massachusetts

Funding The PROLONG study is being funded by AMAG Pharmaceuticals.
Further Information

Publication History

20 March 2018

20 March 2018

Publication Date:
27 April 2018 (online)

Preview

Abstract

The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018.