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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457886
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : March 9, 2017
Wedgewood Pharmacy
National Center for Research Resources (NCRR)
Information provided by:
Georgetown University

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
Preterm Delivery

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.

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Study Type : Observational
Enrollment : 20 participants
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 : July 2005
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457886

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United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Wedgewood Pharmacy
National Center for Research Resources (NCRR)
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Study Director: John Queenan, MD Georgetown University

Layout table for additonal information Identifier: NCT00457886     History of Changes
Other Study ID Numbers: IRB 2005-142
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists