A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that administration of two courses of antenatal corticosteroids, compared
      to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in
      patients delivering prior to 34 weeks' gestation.
    

Detailed description: 
      This is a randomized double-blinded placebo-controlled trial. The objective of this study is
      to evaluate the impact of one versus two courses of antenatal steroids on the incidence of
      major neonatal morbidity including respiratory distress syndrome in patients delivering prior
      to 34 weeks' gestation in a randomized prospective fashion.

      Preterm delivery occurs in approximately 10% of all deliveries in the United States. Preterm
      birth is the cause of 75% of neonatal mortality not mentioning the significantly increased
      morbidity from respiratory distress syndrome, intraventricular hemorrhage, necrotizing
      enterocolitis, and sepsis. Numerous studies have evaluated the safety and efficacy of
      antenatal corticosteroid (ACS) administration in threatened preterm labor.

      National Institutes of Health (NIH) first consensus conference in 1994 evaluated the research
      in this field. Conclusions included the clear evidence that antenatal corticosteroids
      decrease the incidence of RDS in infants born at 29-34 weeks gestation, with a decrease in
      RDS severity for infants born at 24-28 weeks gestation and a decrease in the incidence of
      intraventricular hemorrhage in infants born at 24-28 weeks gestation without harm to mother
      or fetus. Their recommendation was to give a single course of corticosteroids to all pregnant
      women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days.

      Since the studies on the duration of the effects of antenatal corticosteroids in the fetus
      are not conclusive, many obstetricians repeat corticosteroids weekly or bi-weekly to patients
      continuing to be at risk for preterm delivery. Lacking scientific evidence, many
      investigators have performed retrospective analyses regarding the effects of single-course
      versus multiple-course antenatal corticosteroids.

      The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated
      courses of corticosteroids are suggestive of possible benefits, especially in reduction of
      RDS, however, design flaws limit their validity.

      The more recent publication from Caughey and Parer examined the literature for evidence
      regarding a dose response of the benefits and detriments of antenatal corticosteroids. Based
      on their complex mathematical analysis they recommend all fetus' between 24 and 34 weeks'
      gestation at risk for preterm delivery should be given a first course of ANC. If the risk of
      preterm delivery persists the next course should be given 2 weeks later, for a maximum of two
      courses. Consistent with all previous articles, the call for a well designed randomized,
      controlled trial is made.
    

Intervention name(s): Betamethasone or Dexamethasone (2nd course of ACS); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Course of Betamethasone or Dexamethasone; Course of Placebo (NS)
Other intervention name(s): Beta; Dex; Placebo, Normal Saline.
Intervention MeSH terms: Dexamethasone; Betamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterm Labor; Preterm delivery