Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

Phase 1/2 Terminated 159 enrolled Steve N. Caritis, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupOpen-labelBasic science

Summary

The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth. The study is an open label study of pregnant women with one or more prior spontaneous preterm births who are receiving either 250mg of 500 mg of 17-OHPC as a weekly single injection. The safety of the 500 mg dose will also be assessed.

Timeline

Start: 2018-02-12
Primary completion: 2021-09-02
Completion: 2021-09-02

Publications

Caritis SN, Costantine MM, Clark S, Stika CS, Kiley JW, Metz TD, Chauhan SP, Venkataramanan R; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Centers Network. Relationship between plasma concentration of 17-hydroxyprogesterone caproate and gestational age at preterm delivery. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100980. doi: 10.1016/j.ajogmf.2023.100980. Epub 2023 Apr 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	17-hydroxyprogesterone caproate	Unknown	250 mg	Intramuscular
Comparator	17-hydroxyprogesterone caproate	Unknown	500 mg	Intramuscular

Indications

No indication recorded.