Pregnancy Clinical Trial
Official title:
A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy
Verified date | February 2015 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.
Status | Completed |
Enrollment | 61 |
Est. completion date | February 2014 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of Texas | Galveston | Texas |
United States | Magee-Womens Hospital of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | University of Washington | Seattle | Washington |
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
United States,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy. | Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy. We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days. |
Second and third trimesters of pregnancy | No |
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