A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome

Completed · Phase 4 · Has a placebo group

Conditions studied: Preterm Delivery

In brief

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.

Key facts

Study ID

NCT00201643

Run by

Obstetrix Medical Group

People needed

437

Starts

2003-11-01

Expected to finish

2008-02-01

Last updated by the study team

2015-01-07

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 25 to 32 6/7 weeks gestation
• Singleton or twin gestation
• Received 1st course of betamethasone prior to 30 weeks' gestation
• Began 1st course of betamethasone at least 14 days prior to randomization
• Risk of delivery in next 7 days due to either maternal or fetal complication (e.g. preterm labor, severe preeclampsia, IUGR, etc.)
• Intact membranes

You may not qualify if…

• Known major fetal anomalies (eg: anencephaly, renal agenesis etc…)
• High order multiple gestation (triplets or higher)
• Cervical dilation > 5 cm
• Clinical chorioamnionitis prior to initiation of second course (two or more of the following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal tachycardia (>160 beats/min), or white blood cell count >20x109/L.define)
• Ruptured membranes prior to initiation of second course of betamethasone
• Already receiving corticosteroids for other conditions (e.g. Lupus, asthma)
• Maternal condition contraindicating the use of steroids (e.g. HIV, active Tuberculosis)
• Participation in conflicting study

Where it is running

• Desert Good Samaritan Hospital — Mesa, Arizona, United States
• Banner Good Sammaritan Hospital — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• University of Sourthern California-Irvine Medical Center — Orange, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• Swedish Medical Center — Denver, Colorado, United States
• Presbyterian/St Luke's Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Skyridge Medical Center — Lonetree, Colorado, United States
• Mercy Medical Center — Des Moines, Iowa, United States
• Tufts-New England Medical Center — Boston, Massachusetts, United States
• Saint Luke's Hospital, Kansas City — Kansas City, Missouri, United States
• Saint John's Regional Health Center — Springfield, Missouri, United States
• University Med. Ctr. of Southern Nevada — Las Vegas, Nevada, United States
• Sunrise Medical Center — Las Vegas, Nevada, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States
• Evergreen Hospital — Kirkland, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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