Status:
COMPLETED
Study of Pharmacology of 17-OHPC in Pregnancy
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.
Detailed Description
The recently completed trial by the National Institute of Child Health and Human Development (NICHD)-sponsored Maternal-Fetal Medicine Units (MFMU) Network has demonstrated that intramuscular 17-alpha...
Eligibility Criteria
Inclusion
- Singleton gestation prior to 20 0/7 weeks gestation
- Planning to receive or receiving 17-OHPC (250 mg IM weekly)
- Previous history of preterm birth
- Able to give consent
Exclusion
- Fetal demise, anomaly, or growth restriction
- Hepatic or renal dysfunction
- Placental previa or abruptio placenta
- Polyhydramnios/oligohydramnios
- Short cervix or planned cerclage
- Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs
- Participation in another interventional study that influences gestational age at delivery
- Heparin treatment of known platelet count \<100,000/mm3 (because of contraindication to intra-muscular injections)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00409825
Start Date
March 1 2006
End Date
February 1 2014
Last Update
February 27 2015
Active Locations (4)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20010
2
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
3
University of Texas
Galveston, Texas, United States, 77555
4
University of Washington
Seattle, Washington, United States, 98195