title: Trial protocol OPPTIMUM-- does progesterone prophylaxis for the prevention of preterm labour improve outcome?
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN14568373.
authors.affiliation: University of Edinburgh MRC Centre for Reproductive Health, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TY, UK. jane.norman@ed.ac.uk
authors.forename: Jane E
authors.initials: JE
authors.lastname: Norman
authors.forename: Andrew
authors.initials: A
authors.lastname: Shennan
authors.forename: Phillip
authors.initials: P
authors.lastname: Bennett
authors.forename: Steven
authors.initials: S
authors.lastname: Thornton
authors.forename: Stephen
authors.initials: S
authors.lastname: Robson
authors.forename: Neil
authors.initials: N
authors.lastname: Marlow
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.forename: Neil
authors.initials: N
authors.lastname: Sebire
authors.forename: Tina
authors.initials: T
authors.lastname: Lavender
authors.forename: Sonia
authors.initials: S
authors.lastname: Whyte
mesh_terms: D019326:17-alpha-Hydroxyprogesterone / Q000008:administration & dosage / Q000627:therapeutic use; D000282:Administration, Intravaginal; D002648:Child; D002657:Child Development; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007752:Obstetric Labor, Premature / Q000453:epidemiology / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011262:Pregnancy Trimester, Second; D011374:Progesterone / Q000008:administration & dosage / Q000627:therapeutic use*; D011372:Progestins / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D018401:Sample Size
chemical_list: D011372:Progestins; D011374:Progesterone; D019326:17-alpha-Hydroxyprogesterone