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

Sean C. Blackwell; Cynthia Gyamfi-Bannerman; Joseph R. Biggio Jr; Suneet P. Chauhan; Brenna L. Hughes; Judette M. Louis; Tracy Manuck; Hugh S. Miller; Anita F. Das; Robert Birch; Michael J. Jozwiakowski

doi:10.1055/s-0038-1642062

American Journal of Perinatology, Inhaltsverzeichnis

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

Sean C. Blackwell

¹Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas

,

Cynthia Gyamfi-Bannerman

²Department of Obstetrics and Gynecology, Preterm Birth Prevention Center, Columbia University Medical Center, New York, New York

,

Joseph R. Biggio Jr

³Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama

,

Suneet P. Chauhan

¹Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas

,

Brenna L. Hughes

⁴Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina

,

Judette M. Louis

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

,

Tracy Manuck

⁶Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina

,

Hugh S. Miller

⁷Watching Over Mothers and Babies Foundation, Tucson, Arizona

⁸Valley Perinatal Services, Tucson, Arizona

,

Anita F. Das

⁹Das Consulting, San Francisco, California

,

Robert Birch

¹⁰AMAG Pharmaceuticals, Inc, Waltham, Massachusetts

,

Michael J. Jozwiakowski

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

› Institutsangaben

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.

Keywords

hydroxyprogesterone caproate - preterm birth - recurrent preterm birth - 17P - HPC - RCT - clinical trial - preterm birth prevention

Volltext

Referenzen

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