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

Study ID
STU 072010-140

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lisa Moseley
214-648-2591
lisa.moseley@utsouthwestern.edu

Principal Investigator
Brian Casey

Summary

This study is a randomized, double-masked, placebo-controlled clinical trial of 2800 women with singleton pregnancies who are likely to deliver between 34.0 and 36.6 weeks. Women are randomized to one of two treatments:
1. a course of two 2 mL intramuscular (iM) injections containing 12 mg of betamethasone, 24 hours apart
or
2. a similar course of an identical appearing placebo: two 2 mL iM injections of placebo, 24 hours apart

Randomization will be restricted to allow a maximum of 50% of the women to enter the trial at 36.0 to 36.6
weeks.
This study will address the following primary research question: in patients with an anticipated delivery in the late preterm period (34.0 x 36.6 weeks) who have not previously received a course of steroids, does administration of antenatal corticosteroids reduce the need for neonatal respiratory support when compared with no corticosteroids?
Secondary research questions this study will address are:
* Does administration of antenatal corticosteroids decrease other neonatal respiratory and nonrespiratory morbidities and mortality?
* Does administration of antenatal corticosteroids decrease admission to the neonatal intensive care unit (niCu) or intermediate care nursery?
* Does administration of antenatal corticosteroids decrease the number of infant re-hospitalizations, emergency visits, or unanticipated visits to the primary care physician as determined at three and six months of age?

Participant Eligibility

1. Singleton Pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14.0 weeks by project gestational age is acceptable.
2. Gestational age at randomization between 34.0weeks and 36.5 weeks confirmed by study criteria.
3. High probability of delivery in the late preterm period (any one of the following):
a. 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 amnioinfusion

* visible leakage of amniotic fluid from the cervix
or
b. 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

* 75% effaced
or
c. Delivery expected 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. The planned delivery may be for any indication, such as the following:

* prior myomectomy

* prior classical cesarean

* IUGR

* oligohydramnios

* preeclampsia

* nonreassuring fetal heart rate tracing warranting delivery

* abruption

* placenta previa