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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pregnancy, Respiratory Distress Syndrome, Pregnancy Outcomes, Preterm Birth

In brief

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

Key facts

Study ID: NCT01222247
Run by: The George Washington University Biostatistics Center
People needed: 2831
Starts: 2010-10-01
Expected to finish: 2022-08-31
Last updated by the study team: 2023-03-28

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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 criteria
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
or
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% effaced
or
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

You may not qualify if…

Any prior antenatal corticosteroid course during the pregnancy because of potential contamination of the placebo group
Candidate for stress dose corticosteroids because of chronic steroid therapy to prevent suppression of adrenal gland, because of potential contamination of the placebo group
Twin gestation reduced to a singleton gestation at or after 14 weeks 0 days by project gestational age either spontaneously or therapeutically
Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops
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
Pre-gestational diabetes - exclude if the patient was on medication (insulin, glyburide) prior to pregnancy
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
Participation in another interventional study that influences neonatal morbidity and mortality
Participation in this trial in a previous pregnancy
Delivery at a non-network hospital
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 weeks.

Where it is running

University of Alabama - Birmingham — Birmingham, Alabama, United States
Stanford University — Stanford, California, United States
University of Colorado — Denver, Colorado, United States
Northwestern University — Chicago, Illinois, United States
Wayne State University — Detroit, Michigan, United States
Columbia University — New York, New York, United States
University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
Duke University — Durham, North Carolina, United States
Case Western Reserve University — Cleveland, Ohio, United States
Ohio State University — Columbus, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Pittsburgh Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
Brown University — Providence, Rhode Island, United States
University of Texas - Southwest — Dallas, Texas, United States
University of Texas - Galveston — Galveston, Texas, United States
University of Texas - Houston — Houston, Texas, United States
University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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