Study of Pharmacology of 17-OHPC in Pregnancy
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second
      and third trimesters.
    

Detailed description: 
      The recently completed trial by the National Institute of Child Health and Human Development
      (NICHD)-sponsored Maternal-Fetal Medicine Units (MFMU) Network has demonstrated that
      intramuscular 17-alpha-hydroxyprogesterone caproate (17-OHPC) substantially reduces the rate
      of preterm birth in women at high risk for preterm delivery because of a prior spontaneous
      preterm birth. No other strategy or treatment for prevention of preterm birth has proven to
      be effective. Consequently, the American College of Obstetricians and Gynecologists has
      cautiously supported this treatment but points out that much more information about this
      therapy and alternative therapies is required. Although a large body of evidence exists about
      the safety of this treatment, almost nothing is known about the pharmacology of this agent,
      especially in pregnancy. The purpose of this study is to define the pharmacology of
      17-hydroxyprogesterone caproate in pregnancy. This protocol will focus on pharmacokinetics
      and placental transport and provide preliminary data on the pharmacoepidemiology of 17-OHPC.
      The primary research question of this study is: Do the pharmacokinetics of 17-OHPC as
      represented by area under the concentration vs. time curve after IM injection of 250 mg
      17-OHPC differ between the second and third trimesters of pregnancy? We will obtain blood
      samples prior to and daily for one week after injection of 17-OHPC (8 samples total) for each
      of two parts of the study, with an optional third part for eligible subjects. Additionally,
      blood samples will be collected prior to each weekly injection of the study drug and at time
      of delivery. Approximately 60 subjects (ages 18-45) will be accrued at one of the Obstetrical
      Fetal Pharmacology Research Units (OPRU) Network sites, with 15 at Magee-Womens Hospital of
      the University of Pittsburgh Medical Center. Study treatment will be administered until
      delivery. The total duration of this multi-center study is 2-3 years.
    

Intervention name(s): 17-OHPC; Blood Draws
Intervention type(s): Drug; Procedure
Intervention description(s): Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.; 10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.
Other intervention name(s): 17-alpha-hydroxyprogesterone caproate
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science