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Completed

NCT Number: NCT00418353

Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.

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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Intraventricular Hemorrhage Lung Diseases Neonatal Mortality Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 117913, United States

About this study

We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1, 2002 through July 31, 2004. We excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment. Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers. The statistical analysis was performed in accordance of the intention-to-treat principle. Student t test, Chi square and Fisher exact test were used for analysis. A P value of < .05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women in preterm labor with intact membranes
  • Women with preterm premature rupture of membranes
  • Women been delivered for fetal and maternal indications
  • Gestational age between 24 and 33 6/7 weeks'.

Exclusion criteria

  • Clinical chorioamnionitis
  • known major fetal structural anomalies,
  • known fetal chromosomal abnormalities,
  • prior antenatal steroid exposure,
  • quadruplets and higher order multiple gestation
  • Women who declined enrollment.

Treatment and study plan

Betamethasone(Celestone soluspan) and Dexamethasone

Drug

Primary outcomes

  1. Respiratory distress syndrome

  2. Intraventricular hemorrhage

  3. Neonatal mortality

Secondary outcomes

  1. Periventricular leukomalacia

  2. Necrotizing enterocolitis

  3. Neonatal sepsis

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Stony Brook University

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Jan 4, 2007
Registry last updated
Jan 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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