17OHP-C Dosing Among Obese Pregnant Women
Condition: Premature Birth; Absorption; Chemicals
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is
      associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher
      doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to
      compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
    

Detailed description: 
      Prospective three arm study of women with a prior spontaneous PTB. Non-obese women will
      receive the standard 250 mg weekly dose of 17 OHP-C while obese women will be randomly
      assigned to the standard (250 mg) or higher dose (500 mg). The resulting three groups will
      consist of:

        1. Normal weight women on 250mg 17OHPC

        2. Obese women on 250mg 17OHPC

        3. Obese women on 500mg of 17OHPC

      Initial Enrollment: Pregnant patients receiving prenatal care at one of the USF affiliated
      sites or Washington University in St. Louis sites who report a history of a PTB will be
      approached by the research nurse. The research nurse will explain the study, review
      inclusion/exclusion criteria with the patient, and invite interested potential study
      candidates to sign a medical records release so that records from the previous PTB can be
      reviewed. If the medical records confirm the birth of a previous PTB was of a live born
      singleton gestation between the gestational ages of 20 weeks and 36 weeks and 6 days then the
      patient will be invited to participate in the study. At that time the informed consent form
      will be thoroughly reviewed with the patient, and if the patient desires to enroll, the
      patient will provide informed consent to enroll in the study. Consecutive women with normal
      BMI or obese women meeting the inclusion criteria will be approached to avoid selection bias.

      Randomization: will occur at the time of enrollment. The randomization will be computer
      generated. Randomization envelopes indicating the randomization arm will be prepared ahead of
      time and the next consecutive envelope will be used at time of enrollment.

      Pharmacokinetic studies: Sampling schedule in order to investigate the pharmacokinetics of
      250 mg 17OHP-C weekly as compared to 500 mg 17OHP-C weekly in obese women as well as 250 mg
      in non-obese women will be performed as follows:

      - Using principles described by Caritis et al., four completed weeks of 17OHP-C therapy is
      required prior to sampling anticipating that steady state will be achieved by this time
      point.
    

Intervention name(s): 17-Hydroxyprogesterone Capronate
Intervention type(s): Drug
Intervention description(s): 17-Hydroxyprogesterone Capronate 250mg versus 500mg
Intervention MeSH terms: 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention