Clinical trial NCT00409825: Study of Pharmacology of 17-OHPC in Pregnancy
Official title: A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2006-12-11
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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-hydroxyprogesterone caproate (17-OHPC) substantially reduces the rate of preterm birth in women at high risk for preterm delivery because of a prior spontaneous preterm birth. No other strategy or treatment for prevention of preterm birth has proven to be effective. Consequently, the American College of Obstetricians and Gynecologists has cautiously supported this treatment but points out that much more information about this therapy and alternative therapies is required. Although a large body of evidence exists about the safety of this treatment, almost nothing is known about the pharmacology of this agent, especially in pregnancy. The purpose of this study is to define the pharmacology of 17-hydroxyprogesterone caproate in pregnancy. This protocol will focus on pharmacokinetics and placental transport and provide preliminary data on the pharmacoepidemiology of 17-OHPC. The primary research question of this study is: Do the pharmacokinetics of 17-OHPC as represented by area under the concentration vs. time curve after IM injection of 250 mg 17-OHPC differ between the second and third trimesters of pregnancy? We will obtain blood samples prior to and daily for one week after injection of 17-OHPC (8 samples total) for each of two parts of the study, with an optional third part for eligible subjects. Additionally, blood samples will be collected prior to each weekly injection of the study drug and at time of delivery. Approximately 60 subjects (ages 18-45) will be accrued at one of the Obstetrical Fetal Pharmacology Research Units (OPRU) Network sites, with 15 at Magee-Womens Hospital of the University of Pittsburgh Medical Center. Study treatment will be administered until delivery. The total duration of this multi-center study is 2-3 years.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.
timeFrame: Second and third trimesters of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of University of Pittsburgh Medical Center
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Steve N. Caritis, MD
role: PRINCIPAL_INVESTIGATOR
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