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Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth.
Am J Obstet Gynecol. 2014 Feb; 210(2):128.e1-6.AJ

Abstract

OBJECTIVE

17-alpha hydroxyprogesterone caproate 250 mg weekly reduces recurrent spontaneous preterm birth in women with a prior spontaneous preterm birth by 33%. The dose is not based on pharmacologic considerations. A therapeutic concentration has not been determined hampering any attempt to optimize treatment. This study evaluated the relationship between 17-alpha hydroxyprogesterone caproate plasma concentrations and the rate of spontaneous preterm birth in women with singleton gestation.

STUDY DESIGN

A single blood sample was obtained between 25 and 28 weeks' gestation from 315 women with a spontaneous preterm birth who participated in a placebo-controlled, prospective, randomized clinical trial evaluating the benefit of omega-3 supplementation in reducing preterm birth. All women in the parent study received 17-alpha hydroxyprogesterone caproate and 434 received omega-3 supplementation and 418 received a placebo. Plasma from 315 consenting women was analyzed for 17-alpha hydroxyprogesterone caproate concentration.

RESULTS

There were no differences between placebo and omega-3 supplemented groups in demographic variables, outcomes or in mean 17-alpha hydroxyprogesterone caproate concentration. Plasma concentrations of 17-alpha hydroxyprogesterone caproate ranged from 3.7-56 ng/mL. Women with plasma concentrations of 17-alpha hydroxyprogesterone caproate in the lowest quartile had a significantly higher risk of spontaneous preterm birth (P = .03) and delivered at significantly earlier gestational ages (P = .002) than did women in the second to fourth quartiles. The lowest preterm birth rates were seen when median 17-alpha hydroxyprogesterone caproate concentrations exceeded 6.4 ng/mL.

CONCLUSION

Low plasma 17-alpha hydroxyprogesterone caproate concentration is associated with an increased risk of spontaneous preterm birth. This finding validates efficacy of this treatment but suggests that additional studies are needed to determine the optimal dosage.

Authors+Show Affiliations

Department of Obstetrics and Gynecology and Reproductive Sciences and Pharmaceutical Sciences, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, PA.Department of Obstetrics and Gynecology and Reproductive Sciences and Pharmaceutical Sciences, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, PA.The George Washington University Biostatistics Center, Washington, DC.Department of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, and University of North Carolina at Chapel Hill, Chapel Hill, NC.Maternal-Fetal Medicine Units, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI.Department of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, and University of North Carolina at Chapel Hill, Chapel Hill, NC.Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT.Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY.Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH.Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI.Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL.Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH.Drexel University College of Medicine, Philadelphia, PA.Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL.Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, Houston, TX.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24113254

Citation

Caritis, Steve N., et al. "Relationship Between 17-alpha Hydroxyprogesterone Caproate Concentration and Spontaneous Preterm Birth." American Journal of Obstetrics and Gynecology, vol. 210, no. 2, 2014, pp. 128.e1-6.
Caritis SN, Venkataramanan R, Thom E, et al. Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. Am J Obstet Gynecol. 2014;210(2):128.e1-6.
Caritis, S. N., Venkataramanan, R., Thom, E., Harper, M., Klebanoff, M. A., Sorokin, Y., Thorp, J. M., Varner, M. W., Wapner, R. J., Iams, J. D., Carpenter, M. W., Grobman, W. A., Mercer, B. M., Sciscione, A., Rouse, D. J., & Ramin, S. (2014). Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. American Journal of Obstetrics and Gynecology, 210(2), e1-6. https://doi.org/10.1016/j.ajog.2013.10.008
Caritis SN, et al. Relationship Between 17-alpha Hydroxyprogesterone Caproate Concentration and Spontaneous Preterm Birth. Am J Obstet Gynecol. 2014;210(2):128.e1-6. PubMed PMID: 24113254.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. AU - Caritis,Steve N, AU - Venkataramanan,Raman, AU - Thom,Elizabeth, AU - Harper,Margaret, AU - Klebanoff,Mark A, AU - Sorokin,Yoram, AU - Thorp,John M,Jr AU - Varner,Michael W, AU - Wapner,Ronald J, AU - Iams,Jay D, AU - Carpenter,Marshall W, AU - Grobman,William A, AU - Mercer,Brian M, AU - Sciscione,Anthony, AU - Rouse,Dwight J, AU - Ramin,Susan, AU - ,, Y1 - 2013/10/07/ PY - 2013/07/10/received PY - 2013/09/10/revised PY - 2013/10/04/accepted PY - 2013/10/12/entrez PY - 2013/10/12/pubmed PY - 2014/3/19/medline KW - 17-hydroxyprogesterone caproate concentration-response KW - dose response KW - pharmacodynamics SP - 128.e1 EP - 6 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 210 IS - 2 N2 - OBJECTIVE: 17-alpha hydroxyprogesterone caproate 250 mg weekly reduces recurrent spontaneous preterm birth in women with a prior spontaneous preterm birth by 33%. The dose is not based on pharmacologic considerations. A therapeutic concentration has not been determined hampering any attempt to optimize treatment. This study evaluated the relationship between 17-alpha hydroxyprogesterone caproate plasma concentrations and the rate of spontaneous preterm birth in women with singleton gestation. STUDY DESIGN: A single blood sample was obtained between 25 and 28 weeks' gestation from 315 women with a spontaneous preterm birth who participated in a placebo-controlled, prospective, randomized clinical trial evaluating the benefit of omega-3 supplementation in reducing preterm birth. All women in the parent study received 17-alpha hydroxyprogesterone caproate and 434 received omega-3 supplementation and 418 received a placebo. Plasma from 315 consenting women was analyzed for 17-alpha hydroxyprogesterone caproate concentration. RESULTS: There were no differences between placebo and omega-3 supplemented groups in demographic variables, outcomes or in mean 17-alpha hydroxyprogesterone caproate concentration. Plasma concentrations of 17-alpha hydroxyprogesterone caproate ranged from 3.7-56 ng/mL. Women with plasma concentrations of 17-alpha hydroxyprogesterone caproate in the lowest quartile had a significantly higher risk of spontaneous preterm birth (P = .03) and delivered at significantly earlier gestational ages (P = .002) than did women in the second to fourth quartiles. The lowest preterm birth rates were seen when median 17-alpha hydroxyprogesterone caproate concentrations exceeded 6.4 ng/mL. CONCLUSION: Low plasma 17-alpha hydroxyprogesterone caproate concentration is associated with an increased risk of spontaneous preterm birth. This finding validates efficacy of this treatment but suggests that additional studies are needed to determine the optimal dosage. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/24113254/Relationship_between_17_alpha_hydroxyprogesterone_caproate_concentration_and_spontaneous_preterm_birth_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(13)01046-6 DB - PRIME DP - Unbound Medicine ER -