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

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)
  • Parkland Health & Hospital System

Lisa Moseley

Principal Investigator
Brian Casey

Official Title

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

Brief Overview

Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely
to be admitted to a special care nursery, and more likely to suffer respiratory
complications than infants born at term. The use of antenatal corticosteroids has been shown
to improve lung function in very premature infants, but has not been evaluated in those
likely to deliver in the late preterm period.

This research study will attempt to answer the following primary research question: Do
steroids, compared to no steroids, decrease babies' need for oxygen support when given to
pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks
gestation? The research study will also collect information on whether steroids improve the
chances that the baby will not get sick from other causes.


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

The rate of preterm birth has steadily increased in the United States over the past 10
years. This increase is driven in part by the rising rate of late preterm birth, defined as
those births occurring between 34 and 36 weeks. Late preterm infants experience a higher
rate of readmission than their term counterparts, and these infants are more likely to
suffer complications such as respiratory distress, kernicterus, feeding difficulties, and
hypoglycemia. Late preterm infants also have a higher mortality for all causes when compared
to term infants. 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. If shown to reduce the need for respiratory
support and thus to decrease the rate of special care nursery admissions and improve
short-term outcomes, the public health and economic impact will be considerate.

This protocol describes a randomized placebo controlled trial to evaluate whether antenatal
corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the
rate of neonatal intensive care unit (NICU) admissions and improving short-term outcomes in
the late preterm infant.

Participant Eligibility

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 34,0weeks 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 study criteria.


- 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 80% effaced


- 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:

- 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)

- Preterm labor does not satisfy protocol criteria - exclude if patient has intact
membranes with no delivery planned and contractions are more than 10 minutes apart or
if the cervix is both less than 3cm dilated and less than 80% effaced

- Fetal death / major fetal anomaly / fetus non-viable - exclude if the patient has a
major fetal anomaly or the fetus is not viable

- Delivery expected < 12 hours after randomization - this includes 1) ruptured
membranes with cervical dilation ≥ 3cm or more than 6 contractions per hour unless
pitocin is deferred for at least 12 hours 2) evidence of non-reassuring fetal status
requiring immediate delivery 3) chorio-amnionitis 4) Cervical dilation ≥ 8 cm

- Prior corticosteroids for fetal lung maturity - exclude if patient was given
corticosteroids for fetal lung maturity before 34 weeks

- Systemic corticosteroids for other indications - exclude if patient was given
systemic corticosteroids for indication other than fetal lung maturity

- No ultrasound < 20 weeks for unsure last menstrual period (LMP). If the patient has
an unsure LMP but she had no dating ultrasound before 20 weeks by ultrasound
parameters, she is excluded.

- No ultrasound < 24 weeks for sure LMP. If the patient has an sure LMP but she had no
dating ultrasound before 24 weeks by ultrasound parameters, she is excluded

- Cervical dilation ≥ 8 cm

- Project gestational age < 34,0 weeks or ≥ 36,6 weeks

- Delivery planned at project gestational age ≥ 36,6 weeks

- Known congenital malformation

- Fetal reduction/loss ≥ 14 weeks - exclude if the singleton pregnancy is due to
reduction or fetal loss from a twin pregnancy at greater or equal to 14 weeks

- Gestational diabetes

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

- Maternal contraindication to betamethasone - exclude if the patient has a known
contraindication to betamethasone

- Chorioamnionitis - exclude if patient is diagnosed with chorioamnionitis

- Physician planning to give steroids - exclude if patient's physician is planning to
give her steroids

- Physician refusal for other reasons - exclude if patient's physician refuses to allow
the patient to participate in the study

- Refusal to sign medical record release

- Participation in conflicting study / this study before - exclude if the patient is
participating in an antenatal study in which the clinical status or intervention may
influence neonatal respiratory outcome, or if she was previously enrolled in this

- Multifetal gestation. Exclude if current multifetal gestation or a single gestation
resulting from a reduction of a multiple of higher order than twins

- Delivery at a non-participating hospital

- Gestational age 36,0 or more and quota already reached.