Study of Pharmacology of 17-OHPC in Pregnancy

Pregnancy Clinical Trial

Official title:

A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409825
• Other study ID #: IRB #0603056
• Secondary ID: 5U10HD047905-02
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2006
• Last updated: February 9, 2015
• Start date: March 2006
• Est. completion date: February 2014

Study information

• 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

Clinical Trial Summary

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.

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.

Recruitment information / eligibility

• 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• 17-OHPC
Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.

Procedure:
• Blood Draws
10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (35)

ACOG News Release: Progesterone recommended in certain high risk pregnancies to help prevent preterm birth. October 31, 2003

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Lye S: Personal communication

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* Note: There are 35 references in all — Click here to view all references

Outcome

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