Study of Pharmacology of 17-OHPC in Pregnancy

NCT00409825 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB #06030565U10HD047905-02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Part 1

EXPERIMENTAL

Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 3, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 4: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.

Drug: 17-OHPC; Procedure: Blood Draws

Interventions

17-OHPC DRUG

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

Also known as: 17-alpha-hydroxyprogesterone caproate

Part 1

Blood Draws PROCEDURE

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.

Part 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Georgetown University

Washington D.C., District of Columbia, 20010, United States

Location

Magee-Womens Hospital of University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas

Galveston, Texas, 77555, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (36)

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MeSH Terms

Interventions

17-alpha-Hydroxyprogesterone; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Steve N. Caritis, MD
• Organization: University of Pittsburgh

scaritis@mail.magee.edu

412-641-4874

Study Officials

• Steve N. Caritis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: February 1, 2014
• Last Updated: February 27, 2015
• Results First Posted: February 9, 2015

Record last verified: 2015-02

Locations

US (4)