Safety signals of 17-OHP-C use in pregnancy and efficacy in the prevention of preterm birth

Journal of Maternal-Fetal and Neonatal Medicine

Volumn 22, Issue 6, 2009, Pages 540-542

  Calda, Pavel ^a  

^a CHARLES UNIVERSITY   (Czech Republic)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROXYPROGESTERONE CAPROATE; PROGESTERONE; 17-ALPHA-HYDROXY-PROGESTERONE CAPROATE; PHARMACOLOGICAL BIOMARKER; PROGESTERONE DERIVATIVE;

CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; EMBRYOTOXICITY; FERTILIZATION IN VITRO; FETOTOXICITY; FIRST TRIMESTER PREGNANCY; HUMAN; INFERTILITY; MATERNAL MORBIDITY; NONHUMAN; NOTE; PREGNANCY; PREGNANCY DIABETES MELLITUS; PREMATURE LABOR; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SPONTANEOUS ABORTION; ARTICLE; EVALUATION; FEMALE; NEWBORN; PREMATURITY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

BIOMARKERS, PHARMACOLOGICAL; FEMALE; HUMANS; HYDROXYPROGESTERONES; INFANT, NEWBORN; PREGNANCY; PREMATURE BIRTH; PROGESTERONE CONGENERS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 69149109370     PISSN: 14767058     EISSN: 14764954     Source Type: Journal    
DOI: 10.1080/14767050802556042     Document Type: Note

References (21)

1. Christian MS, Brent RL, Calda P. Embryo-fetal toxicity signals for 17-alpha-hydroxyprogesterone caproate in high risk pregnancies: a review of the non-clinical literature for embryofetal toxicity with progestins. J Maternal Fetal Neonatal Med 2007;20:89-112.
2. Seegmiller RE, Nelson GW, Johnson CK. Evaluation of the teratogenic potential of delalutin (17alpha-hydroxyprogesterone caproate) in mice. Teratology 1983;28:201-208.
3. Hendrickx AG, Korte, R, Leuschner F, Neumann BW, Poggel A, Binkerd P, Prahalada S, Gunzel P. Embriotoxicity of sex steroidal hormones in nonhuman primates. II. Hydroxyprogesterone caproate, estradiol valerate. Teratology 1987;35:129.
4. Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington D.C.: The National Academies Press; 2006.
5. Review by the Division of Reproduction and Urologic Products, Food and Drug Administration; August 2, 2006. Available: http://www.fda.gov/ohrms/ dockets/ac/06/briefing/2006-4227B1- 02-01-FDA-Background.pdf (accessed 30May 2008).
6. Summary minutes for the Advisory Committees for Reproductive Health Drugs. August 29, 2006. Available: http:// www.fda.gov/ohrms/dockets/ac/06/ minutes/2006-4227M1.pdf (accessed 30 May 2008).
7. Fonseca EB, Bittar RE, Carvalho HB, ZugaibM. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled doubleblind study. Am J Obstet Gynecol 2003;188:419-424.
8. Sexton DJ, O'Reilly MW, Friel AM, Morrison JJ. Functional effects of 17alpha-hydroxyprogesterone caproate on human myometrial contractility in vitro. Reprod Biol Endocrinol 2004;2:80.
9. Csapo A. The ''see-saw'' theory of parturition. CIBA Foundation Syposium 1977;47:159-210.
10. Ruddock N, Shi S, Jain S, Moore G, Hankins G, Romero R, Garfield R. Progesterone (P4), but not 17 alpha hydroxyprogesterone caproate (17P) inhibits human myometrial contractions. Am J Obstet Gynecol 2007;197:6.
11. Crinone package insert, http://www.crinoneusa.com/ professionals/ Prescribing-Information.pdf, revised 2006.
12. O'Brien JM, Adair CD, Lewis DF, Hall DR, DeFranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, et al. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2007;30:687-696; http://www3.interscience.wiley. com/journal/99020267/home (free download).
13. Keirse MJNC. Progestogen administration in pregnancy may prevent preterm delivery. Br J Obstet Gynecol 1990;97: 149-154.
14. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Menachem M, Varner MW, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New Engl J Med 2003; 348:2379-2385.
15. Rebarber A, Ferrara LA, Hanley ML, Istwan NB, Rhea DJ, Stanziano GJ, Saltzman DH. Increased recurrence of preterm delivery with early cessation of 17-alpha-hydroxyprogesterone caproate. Am J Obstet Gynecol 2007;196:224.
16. Rebarber A, Istwan NB, Russo-Stieglitz K, Cleary-Goldman J, Rhea DJ, Stanziano GJ, Saltzman DH. Increased incidence of gestational diabetes in women receiving prophylactic 17alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery. Diabetes Care 2007;30:2277-2280.
17. Dodd JM, Flenady V, Cincotta R, Crowther CA. The cochrane database of systematic reviews. 2006 (1) Art. No.: CD004947. DOI: 10.1002/14651858.CD004947. pub2. www.cochrane. org/reviews/en/ab004947.html (accessed 30 May 2008).
18. Wesley B. Meeting of the advisory committee for reproductive health drugs. August 29, 2006. Available: http://www.fda.gov/ ohrms/dockets/ac/06/ slides/2006-4227S1-02-03-FDA-Wesley.ppt (slide #9, accessed 30 May 2008).
19. Review by the Division of Reproduction and Urologic Products, Food and Drug Administration; August 2, 2006. Available: http://www.fda.gov/ohrms/ dockets/ac/06/briefing/ 2006-4227B1-02-01-FDA-Background.pdf (page 27-28, accessed 30 May 2008).
20. Brancazio LR, Murtha AP, Heine RP. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003;349:1087.
21. Review by the Division of Reproduction and Urologic Products, Food and Drug Administration; August 2, 2006. Available: http://www.fda.gov/ohrms/ dockets/ac/06/briefing/ 2006-4227B1-02-01-FDA-Background.pdf (page 41-42, accessed 30 May 2008).