Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial


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Trial ID: NCT01222247


This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period

Official Title

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

Stanford Investigator(s)

Yasser El-Sayed, Professor
Yasser El-Sayed, Professor

Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery


Inclusion Criteria:

Singleton Pregnancy. A twin pregnancy reduced to singleton (either spontaneously or
therapeutically) before 14,0 weeks by project gestational age is acceptable

Gestational age at randomization between 34,0 weeks and 36,5 weeks confirmed by study

High probability of delivery in the late preterm period (any one of the following):

   - Membrane rupture as defined by the occurrence of any two of the following: pooling of
   fluid in the vaginal vault, positive Nitrazine test, ferning of vaginal fluid,
   positive AmniSure test; or any one of the following: indigo carmine pooling in the
   vagina after amnioinfustion, visible leakage of amniotic fluid from the cervix


   - Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular
   uterine contractions in an observation period of no more than 60 minutes and at least
   one of the following: cervix greater than or equal to 3cm dilated or at least 75%


   - Planned delivery by induction of labor or cesarean section in no less than 24 hours
   and no more than 7 days, as deemed necessary by the provider. An induction must be
   scheduled to start by 36,5 weeks at the latest, whereas a cesarean delivery must be
   scheduled by 36,6 weeks at the latest. Therefore the latest gestational age for
   randomization is 36,4 weeks for a planned induction. The planned delivery may be for
   any indication, such as the following: prior myomectomy, prior classical cesarean,
   intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, nonreassuring
   fetal heart rate tracing warranting delivery, abruption, placenta previa

Exclusion Criteria:

   1. Any prior antenatal corticosteroid course during the pregnancy because of potential
   contamination of the placebo group

   2. Candidate for stress dose corticosteroids because of chronic steroid therapy to
   prevent suppression of adrenal gland, because of potential contamination of the
   placebo group

   3. Twin gestation reduced to a singleton gestation at or after 14 weeks 0 days by project
   gestational age either spontaneously or therapeutically

   4. Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops

   5. Maternal contraindication to betamethasone: hypersensitivity reaction to any
   components of the medication, idiopathic thromboycytopenic purpura, systemal fungal
   infection in case of exacerbation by betamethasone, use of amphotericin B due to the
   possibility of heart failure with concomitant betamethasone

   6. Pre-gestational diabetes - exclude if the patient was on medication (insulin,
   glyburide) prior to pregnancy

   7. Delivery expected within 12 hours of randomization, because of insufficient time of
   corticosteroids to confer benefit, including any of the following:

   A. Rupture of Membranes (ROM) does not satisfy protocol criteria - exclude if the
   patient being evaluated for Preterm Premature Rupture of Membranes (pPROM), does not
   have preterm labor or planned delivery and does not satisfy the spontaneous membrane
   rupture criteria (any 2 of: positive Nitrazine test, pooling of fluid in the vaginal
   vault test or ferning of vaginal fluid; or indigo carmine pooling in the vagina after
   amnioinfusion; or visible leakage of amniotic fluid from the cervix) B. Rupture of the
   membranes in the presence of more than 6 contractions per hour or cervical dilation of
   3 cm or more, unless oxytocin was withheld for at least 12 hours (other induction
   agents allowed) C. Chorioamnionitis - exclude if patient is diagnosed with
   chorioamnionitis D. Cervical dilation ≥ 8 cm E. Evidence of non-reassuring fetal
   status requiring immediate delivery

   8. Participation in another interventional study that influences neonatal morbidity and

   9. Participation in this trial in a previous pregnancy

10. Delivery at a non-network hospital

11. At 36, 0 weeks to 36, 5 weeks and quota for 36 weeks already met. To ensure there is
   an adequate proportion of women presenting at 34 to 35 weeks of gestation, enrollment
   will be restricted so that no more than 50% of the women in the trial present at 36


drug: Placebo

drug: Betamethasone


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dr. Yasser El-Sayed
650 725-8623