Status:
COMPLETED
Measurement of Hormone Levels in Patients Receiving 17-HPC for Preterm Delivery
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Wedgewood Pharmacy
National Center for Research Resources (NCRR)
Conditions:
Preterm Delivery
Eligibility:
FEMALE
18-45 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
End Date :
June 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00457886
Start Date
July 1 2005
End Date
June 1 2007
Last Update
March 9 2017
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007