Abstract
BackgroundPreterm 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/DesignThe 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.DiscussionOPPTIMUM 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.Trial registrationISRCTN14568373
Highlights
Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location
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. It will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome
Despite the many publications on the use of progesterone for the prevention of preterm birth, we believe that that further data, on the long term effect for the baby, is needed before the use of progesterone can be routinely recommended in pregnant women at high risk of preterm birth
Summary
Despite the many publications on the use of progesterone for the prevention of preterm birth, we believe that that further data, on the long term effect for the baby, is needed before the use of progesterone can be routinely recommended in pregnant women at high risk of preterm birth. For example the American College of Obstetricians and Gynecologists, in guidelines published in 2008 and reaffirmed in 2011 [26] is more positive about the use of progesterone, saying that “progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and a prior spontaneous preterm [before 37 weeks] birth” and that “progesterone supplementation for asymptomatic women with a very short cervical length (less than 15 mm) may be considered”. The OPPTIMUM study will provide further evidence on the effectiveness of vaginal progesterone for the prevention of preterm delivery in selected high risk women It will determine whether prevention of preterm birth by progesterone prophylaxis is associated with long term benefit for the baby
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