17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypothesis: Among women with twin or triplet pregnancies, weekly injections of
      17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will
      reduce neonatal morbidity by reducing the rate of preterm delivery.

      This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus
      placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk
      factor for preterm birth. The two risk factors to be studied are:

        1. Twin pregnancy

        2. Triplet pregnancy
    

Detailed description: 
      Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally,
      12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA).
      Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of
      preterm birth among women with a history of prior preterm birth. However, it has not been
      demonstrated that this reduction in preterm birth is accompanied by a clinically significant
      reduction in neonatal complications. Further, most women who deliver preterm have no history
      of a prior preterm birth. Little is known about whether progesterone treatment is effective
      in women with other risk factors for preterm birth such as multiple gestation. The proposed
      study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess
      the impact on neonatal health, not merely the impact on gestational age at delivery. Prior
      studies were not designed to be large enough to have statistical power to assess effects on
      neonatal morbidity.

      In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with
      17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis
      approximately doubles the world-wide experience, with 306 women under treatment, of whom 73
      delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction
      in neonatal complications but only a reduction in preterm birth rates.

      The present study is the first to be specifically designed to have adequate power to test
      whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors
      for preterm birth.
    

Intervention name(s): 17-alpha-hydroxyprogesterone caproate injectable; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.; Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
Other intervention name(s): 170HP; Normal Saline
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preterm Birth; Preterm Delivery; Multiple gestation; 17-alpha-hydroxyprogesterone caproate; Progesterone