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

NCT00201643 | Completed Phase 4 Results DMC

• 1 other identifier: OBX0001
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Preterm Delivery

Keywords

Preterm Labor; Preterm delivery

Outcome Measures

Primary Outcomes (1)

• Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.

  This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death

  From birth to 28 days of life

Secondary Outcomes (8)

• Gestational Age at (@) Delivery

  gestational age at delivery in weeks of gestation

• Neonatal Birth Weight Reported in Grams

  At time of Birth

• Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.

  Measured at birth.

• Neonatal Head Circumference Taken at Time of Birth.

  Birth

• Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.

  birth to 28 days of life

Study Arms (2)

1 Test group

ACTIVE COMPARATOR

Receive 2nd Course = Study drug (betamethasone or dexamethasone)

Drug: Betamethasone or Dexamethasone (2nd course of ACS)

2 - Control

PLACEBO COMPARATOR

Placebo group = received placebo course

Drug: Placebo

Interventions

Betamethasone or Dexamethasone (2nd course of ACS) DRUG

Course of Betamethasone or Dexamethasone

Also known as: Beta, Dex

1 Test group

Placebo DRUG

Course of Placebo (NS)

Also known as: Placebo, Normal Saline.

2 - Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (22)

Desert Good Samaritan Hospital

Mesa, Arizona, 85202, United States

Location

Banner Good Sammaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90801-1428, United States

Location

University of Sourthern California-Irvine Medical Center

Orange, California, 92868, United States

Location

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Swedish Medical Center

Denver, Colorado, 80110, United States

Location

Presbyterian/St Luke's Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Skyridge Medical Center

Lonetree, Colorado, 80124, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Saint Luke's Hospital, Kansas City

Kansas City, Missouri, 64111, United States

Location

Saint John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

University Med. Ctr. of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Sunrise Medical Center

Las Vegas, Nevada, 89109, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Evergreen Hospital

Kirkland, Washington, 98034, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

Related Publications (5)

• Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consens Statement. 1994 Feb 28-Mar 2;12(2):1-24.

  PMID: 7728157 BACKGROUND

• Vermillion ST, Soper DE, Newman RB. Is betamethasone effective longer than 7 days after treatment? Obstet Gynecol. 2001 Apr;97(4):491-3. doi: 10.1016/s0029-7844(00)01178-9.

  PMID: 11275015 BACKGROUND

• Antenatal corticosteroids revisited: repeat courses. NIH Consens Statement. 2000 Aug 17-18;17(2):1-18.

  PMID: 11725806 BACKGROUND

• Guinn DA, Atkinson MW, Sullivan L, Lee M, MacGregor S, Parilla BV, Davies J, Hanlon-Lundberg K, Simpson L, Stone J, Wing D, Ogasawara K, Muraskas J. Single vs weekly courses of antenatal corticosteroids for women at risk of preterm delivery: A randomized controlled trial. JAMA. 2001 Oct 3;286(13):1581-7. doi: 10.1001/jama.286.13.1581.

  PMID: 11585480 BACKGROUND

• Caughey AB, Parer JT. Recommendations for repeat courses of antenatal corticosteroids: a decision analysis. Am J Obstet Gynecol. 2002 Jun;186(6):1221-6; discussion 1226-9. doi: 10.1067/mob.2002.123742.

  PMID: 12066102 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Interventions

Betamethasone; Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Kimberly A. Maurel, MSN, CNS
• Organization: Obstetrix Medical Group, Inc.

kimberly_maurel@pediatrix.com

714-593-9171

Study Officials

• Kimberly Maurel, RN, MSN, CNS

  Obstetrix Medical Group, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 7, 2015
• Results First Posted: March 1, 2011

Record last verified: 2014-12

Locations

US (22)