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Completed

NCT Number: NCT00453141

Betamethasone Dosing Interval - 12 or 24 Hours?

The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

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Key information

Conditions

Preterm Delivery Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Atelectasis Respiratory Tract Diseases Urogenital Diseases

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cooper University Hospital, Camden, New Jersey, United States

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About this study

Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
  • Gestational age between 23 and 34 weeks gestational age.
  • Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.

Exclusion criteria

  • Patients at <23 or >34 weeks gestational age.
  • Known drug allergy to betamethasone.
  • Given steroid other than betamethasone for lung maturation.
  • Any contraindication to steroid therapy.

Treatment and study plan

dosing of Betamethasone

Drug

Primary outcomes

  1. The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network)

    Time frame: Until neonatal discharge

Secondary outcomes

  1. Incidence of INH, NEC, BPD, Blindness

    Time frame: until neonatal discharge

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 28, 2007
Registry last updated
Nov 10, 2009

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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