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

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The PROLONG trial investigates hydroxyprogesterone caproate injection for preventing preterm birth. This study aims to reduce neonatal complications in high-risk pregnancies.

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Area of Science:

  • Obstetrics and Gynecology
  • Neonatal Medicine
  • Clinical Trials

Background:

  • Preterm birth (PTB) is a leading cause of neonatal morbidity and mortality.
  • Identifying effective interventions to prevent PTB in women with a history of spontaneous PTB is critical.
  • Makena (hydroxyprogesterone caproate injection) is being evaluated for its potential to prolong gestation.

Purpose of the Study:

  • To describe the background, rationale, and methods of the PROLONG trial.
  • To assess the safety and efficacy of hydroxyprogesterone caproate injection in reducing PTB and neonatal complications.
  • To evaluate the impact of Makena on singleton gestations with a prior spontaneous PTB.

Main Methods:

  • A multicenter, multinational, placebo-controlled, randomized clinical trial (RCT).
  • Involves 1,707 women with a singleton gestation and a history of spontaneous PTB.
  • Two coprimary outcomes: PTB before 35 weeks and a composite neonatal morbidity/mortality index.

Main Results:

  • The study is ongoing; recruitment was targeted for completion in 2018.
  • The sample size provides 90% power to detect a 35% reduction in neonatal morbidity and mortality.
  • Secondary outcomes include 2-year infant follow-up.

Conclusions:

  • The PROLONG trial is a significant RCT evaluating a potential treatment for preventing preterm birth.
  • Results will inform clinical practice regarding the use of hydroxyprogesterone caproate injection in high-risk pregnancies.
  • The study aims to improve neonatal outcomes and reduce mortality associated with preterm birth.