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Maternal hormone treatment safe for fetus

November 1, 2007

NEW YORK (Reuters Health) - Treating high-risk pregnant women with a progesterone hormone during the second and third trimester to prevent preterm birth seems to be safe for the fetus, according to a report in Obstetrics & Gynecology.

High levels of progesterone are produced by the placenta, which helps maintain the pregnancy. A drop in the levels of this hormone is thought to be one of the steps that stimulate the onset of labor.

Treatment with 17 alpha-hydroxyprogesterone caproate has been shown to reduce the rate of repeat preterm births at less than 37, 35, and 32 weeks of pregnancy, the authors explain, but it remains unclear whether such treatment is safe for the fetus.

Allison T. Northen from the University of Alabama at Birmingham and colleagues investigated the developmental and other health outcomes of 194 children who were exposed as fetuses to 17 alpha-hydroxyprogesterone in the second and third trimesters. The results were compared with those for 84 unexposed children.

There was no evidence that the use of the hormone impaired development, and there was no link with congenital malformations.

"Overall," the investigators conclude, "this study provides reassurance that 17 alpha-hydroxyprogesterone caproate is safe for the fetus when administered in the second and third trimesters."

SOURCE: Obstetrics and Gynecology, October 2007.

Follow-up of Children Exposed In Utero to 17 -Hydroxyprogesterone Caproate Compared With Placebo

Allison T. Northen, RN, BSN¹, Gwendolyn S. Norman, RN, BSN, MPH², Kristine Anderson, RN, BSN³, Lisa Moseley, RN⁴, Michelle DiVito, RN, MSN⁵, Margaret Cotroneo, RN, CCRC⁶, Melissa Swain, RN⁷, Sabine Bousleiman, RNC, MSN⁸, Francee Johnson, RN, BSN⁹, Karen Dorman, RN, MS¹⁰, Cynthia Milluzzi, RN, BSN¹¹, Jo-Ann Tillinghast, RN, MSN¹², Marcia Kerr, RN, CCRC¹³, Gail Mallett, BSN, CCRC¹⁴, Elizabeth Thom, PhD¹⁵, Susan Pagliaro¹⁶, Garland D. Anderson, MD¹⁷ for the National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*

From the Departments of Obstetrics and Gynecology, ¹Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama; ²Wayne State University, Detroit, Michigan; ³University of Utah, Salt Lake City, Utah; ⁴University of Texas Southwestern Medical Center, Dallas, Texas; ⁵Drexel University, Philadelphia, Pennsylvania; ⁶University of Pittsburgh, Pittsburgh, Pennsylvania; ⁷Wake Forest University, Winston-Salem, North Carolina; ⁸Columbia University, New York, New York; ⁹Ohio State University, Columbus, Ohio; ¹⁰University of North Carolina, Chapel Hill, North Carolina; ¹¹Case Western Reserve University, Cleveland, Ohio; ¹²Brown University, Providence, Rhode Island; ¹³University of Texas at Houston, Houston, Texas; ¹⁴Northwestern University, Chicago, Illinois; ¹⁵the George Washington University Biostatistics Center, Washington, DC; ¹⁶National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland; and ¹⁷the University of Texas Medical Branch, Galveston, Texas.

ABSTRACT

OBJECTIVE: To assess whether there are evident adverse effects of 17 -hydroxyprogesterone caproate after in utero exposure.

METHODS: This study evaluated surviving children of mothers who participated in a multicenter placebo-controlled trial of weekly intramuscular 17 -hydroxyprogesterone caproate, with a 2:1 allocation to 17 -hydroxyprogesterone caproate and placebo, respectively. The guardian was interviewed about the child's general health. Children underwent a physical examination and developmental screen with the Ages and Stages Questionnaire. Gender-specific roles were assessed with the Preschool Activities Inventory.

RESULTS: Of 348 eligible surviving children, 278 (80%) were available for evaluation (194 in the 17 -hydroxyprogesterone caproate group and 84 in the placebo group). The mean age at follow-up was 48 months. No significant differences were seen in health status or physical examination, including genital anomalies, between 17 -hydroxyprogesterone caproate and placebo children. Scores for gender-specific roles (Preschool Activities Inventory) were within the normal range and similar between 17 -hydroxyprogesterone caproate and placebo groups.

CONCLUSION: 17 -hydroxyprogesterone caproate seems to be safe for the fetus when administered in the second and third trimesters.