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Measurement of Hormone Levels in Patients Receiving 17-HPC for Preterm Delivery

Sponsor
Georgetown University (Other)
Overall Status
Completed
CT.gov ID
NCT00457886
Collaborator
Wedgewood Pharmacy (Industry), National Center for Research Resources (NCRR) (NIH)
20
Enrollment
1
Location
23
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-P in order to help understand its mechanism of action in preventing preterm delivery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A recent study by Meis and colleagues published in the New England Journal of Medicine in June 2003 demonstrated a 33% reduction in the rate of preterm delivery in patients with a previous history of preterm delivery who then used weekly 17-P injections in the subsequent pregnancy.

    This is a milestone in the prevention of preterm delivery and is the reason you have chosen to receive treatment with 17-P.

    However, how 17-P works to prevent preterm delivery is unclear. Knowledge of the mechanism of action of 17-P would help in selecting patients for treatment and may be useful in monitoring the efficacy of therapy.

    Studies have suggested that the timing of delivery depends on a type of placental clock, affected by levels of corticotropin-releasing hormone (CRH) and progesterone (P).

    CRH can be thought to act as an accelerator, and P as a brake. Serial injections of 17-P beginning in the second trimester of pregnancy may prevent preterm delivery by maintaining progesterone dominance, and be reflected in increased levels of progesterone and/or 17-P, or decreased levels of cortisol and/or CRH. These are the hormones that will be measured in this study.

    Results of the study will be important whatever the outcome. If there is no measurable change in the hormones measured, this is important to know and investigation of other markers can be pursued. If there is a measurable change in the hormones measured, then this pilot study could serve to support a larger more definitive study, which could lead to very valuable information relating to the practical use of 17-P for the prevention of preterm delivery.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Serum Levels of Hormones Known to Affect Parturition in Patients Receiving 17 Alpha-Hydroxyprogesterone Caproate (17-P) for the Prevention of Preterm Delivery
    Study Start Date :
    Jul 1, 2005
    Study Completion Date :
    Jun 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 45 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Spontaneous preterm delivery in a previous pregnancy, are between 15-20 weeks gestation during the current pregnancy, and have already decided whether or not to receive 17-alphahydroxyprogesterone caproate (17-P) for the prevention of preterm delivery.
      Exclusion Criteria:

      • Multiple gestation

      • Known fetal anomaly

      • Progesterone or heparin treatment during the current pregnancy

      • Seizure disorder

      • Pre-existing or gestational diabetes

      • Hypertension requiring medication

      • Thyroid or adrenal gland disorder

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Georgetown University Medical Center Washington District of Columbia United States 20007

      Sponsors and Collaborators

      • Georgetown University
      • Wedgewood Pharmacy
      • National Center for Research Resources (NCRR)

      Investigators

      • Study Director: John Queenan, MD, Georgetown University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00457886
      Other Study ID Numbers:
      • IRB 2005-142
      First Posted:
      Apr 9, 2007
      Last Update Posted:
      Mar 9, 2017
      Last Verified:
      Mar 1, 2017
      Additional relevant MeSH terms:
      Premature Birth

      Study Results

      No Results Posted as of Mar 9, 2017