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

This study has been completed.
Sponsor:
Collaborators:
Wedgewood Pharmacy
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00457886
First received: April 6, 2007
Last updated: June 30, 2009
Last verified: April 2007
  Purpose

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 Phase
Preterm Delivery.
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Estimated Enrollment: 20
Study Start Date: July 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457886

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Wedgewood Pharmacy
Investigators
Study Director: John Queenan, MD Georgetown University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00457886     History of Changes
Other Study ID Numbers: IRB 2005-142
Study First Received: April 6, 2007
Last Updated: June 30, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Hormones

ClinicalTrials.gov processed this record on September 18, 2014