Norman, Jane E., Shennan, Andrew, Bennett, Phillip R., Thornton, Steven, Robson, Stephen, Marlow, Neil, Norrie, John, Petrou, Stavros, Sebire, N. J. (Neil James), 1968-, Lavender, Tina and Whyte, Sonia. (2012) Trial protocol OPPTIMUM : does progesterone prophylaxis for the prevention of preterm labour improve outcome? BMC Pregnancy and Childbirth, Vol.12 (No.1). p. 79. ISSN 1471-2393

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Abstract

Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth). Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks), improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome.

Item Type:	Journal Article
Subjects:	R Medicine > RG Gynecology and obstetrics
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences
Library of Congress Subject Headings (LCSH):	Premature labor -- Prevention, Progestational hormones
Journal or Publication Title:	BMC Pregnancy and Childbirth
Publisher:	BioMed Central Ltd.
ISSN:	1471-2393
Date:	2012
Volume:	Vol.12
Number:	No.1
Page Range:	p. 79
Identification Number:	10.1186/1471-2393-12-79
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
References:	1. March of Dimes Foundation: March of Dimes White paper on preterm birth: the global and regional toll. White Plains, New York: March of Dimes foundation; 2009. 2. Norman JE, Morris C, Chalmers J: The effect of changing patterns of obstetric care in Scotland (1980–2004) on rates of preterm birth and its neonatal consequences: perinatal database study. PLoS Med 2009, 6(9):e1000153. 3. Goldenberg RL, Culhane JF, Iams JD, Romero R: Epidemiology and causes of preterm birth. Lancet 2008, 371(9606):75–84. 4. Arbyn M, Kyrgiou M, Simoens C, Raifu AO, Koliopoulos G, Martin-Hirsch P, Prendiville W, Paraskevaidis E: Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis. BMJ (Clinical Res Ed) 2008, 337:a1284. 5. da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M: Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J ObstetGynecol 2003, 188(2):419–424. 6. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH, Thornton S, Alfirevic Z, Smith G, Radhakrishnan P, Khoury O, et al: Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007, 357(5):462–469. 7. Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, et al: Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003, 348(24):2379–2385. 8. Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter J, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, et al: Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2011, 38:18–31. 9. Dodd JM, Flenady V, Cincotta R, Crowther CA: Prenatal administration of progesterone for preventing preterm birth. Cochrane Database Syst Rev 2006, 1:CD004947. 10. Dodd JM, Flenady VJ, Cincotta R, Crowther CA: Progesterone for the prevention of preterm birth: a systematic review. Obstet Gynecol 2008, 112(1):127–134. 11. Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, et al: Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 2012, 206(2):124 e121–119. 12. Northen AT, Norman GS, Anderson K, Moseley L, Divito M, Cotroneo M, Swain M, Bousleiman S, Johnson F, Dorman K, et al: Follow-up of children exposed in utero to 17 alpha-hydroxyprogesteronecaproate compared with placebo. ObstetGynecol 2007, 110(4):865–872. 13. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012, 206(5):376–386. 14. Junpeng M, Huang S, Qin S: Progesterone for acute traumatic brain injury. Cochrane Database Syst Rev 2011, 1:CD008409. 15. Kenyon SL, Taylor DJ, Tarnow-Mordi W: Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. Lancet 2001, 357(9261):989–994. 16. Kenyon S, Pike K, Jones DR, Brocklehurst P, Marlow N, Salt A, Taylor DJ: Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008, 372(9646):1319–1327. 17. Hoover RN, Hyer M, Pfeiffer RM, Adam E, Bond B, Cheville AL, Colton T, Hartge P, Hatch EE, Herbst AL, et al: Adverse health outcomes in women exposed in utero to diethylstilbestrol. N Engl J Med 2011, 365(14):1304–1314. 18. Anon: Disability and Perinatal care: report of two working groups. Oxford: NEPU and Oxford HA; 1995. 19. Modi N, Dore CJ, Saraswatula A, Richards M, Bamford KB, Coello R, Holmes A: A case definition for national and international neonatal bloodstream infection surveillance. Arch Dis Child 2009, 94(1):F8–F12. 20. Standards for hospitals providing neonatal intensive and high dependency care and categories of babies requiring neonatal care. 2nd edition.: British Association of Perinatal Medicine; 2001. http://www.bapm.org/publications/ documents/guidelines/hosp_standards.pdf. 21. BAPM/RCPCH Working Group Report: Classification of health status at 2 years as a perinatal outcome. 2008. 22. Edwards IR, Biriell C: Harmonisation in pharmacovigilance. Drug Saf 1994, 10(2):93–102. 23. Honest H, Forbes CA, Duree KH, Norman G, Duffy SB, Tsourapas A, Roberts TE, Barton PM, Jowett SM, Hyde CJ, et al: Screening to prevent spontaneous preterm birth: systematic reviews of accuracy and effectiveness literature with economic modelling. Health Technol Assess 2009, 13(43):1–627. 24. Lachenbruch PA: Analysis of data with excess zeros. Stat Methods Med Res 2002, 11(4):297–302. 25. Farine D, Mundle WR, Dodd J, Basso M, Delisle MF, Grabowska K, Hudon L, Menticoglou SM, Murphy-Kaulbeck LC, Ouellet A, et al: The use of progesterone for prevention of preterm birth. J Obstet Gynaecol Can 2008, 30(1):67–77. 26. American College of Obstetricians and Gynecologists: ACOG committee opinion no 419.on "The use of progesterone to prevent preterm birth". American College of Obstetricians and Gynecologists. Obstet Gynecol 2008, 112:963–965. 27. Shennan A, Jones G, Hawken J, Crawshaw S, Judah J, Senior V, Marteau T, Chinn S, Poston L: Fetal fibronectin test predicts delivery before 30 weeks of gestation in high risk women, but increases anxiety. BJOG 2005, 112(3):293–298. 28. Sanchez-Ramos L, Kaunitz AM, Delke I: Progestational agents to prevent preterm birth: a meta-analysis of randomized controlled trials. Obstet Gynecol 2005, 105(2):273–279. 29. Wolke D, Meyer R: Ergebnisse der Bayerischen Entwicklungstudie: implikationen fur theorie und praxis. Kindheit und Entwicklung 1999, 8:24–36.
URI:	http://wrap.warwick.ac.uk/id/eprint/52065

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