Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Overview

A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

Full Title of Study: “Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It’s All About Timing”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: October 1, 2019

Detailed Description

A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 – 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.

Interventions

  • Drug: Betamethasone
    • Corticosteroids

Arms, Groups and Cohorts

  • Betamethasone group 1
    • Betamethasone Group 1 (5am-11am)
  • Betamethasone Group 2
    • Betamethasone Group 2 (11am-5pm)
  • Betamethasone Group 3
    • Betamethasone Group 3 (5pm-11pm)
  • Betamethasone Group 4
    • Betamethasone Group 4 (11pm-5am).

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of neonatal hypoglycemia
    • Time Frame: 7 years
    • Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time

Participating in This Clinical Trial

Inclusion Criteria

• women between 24 – 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution

Exclusion Criteria

  • higher order multiple pregnancies
  • women who were given more than one course of betamethasone during the course of the current pregnancy
  • known major congenital anomalies.

Gender Eligibility: Female

Pregnant women and their newborns

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yaniv Zipori MD, Principal Investigator – Rambam Health Care Campus
  • Overall Official(s)
    • Yaniv Zipori, M.D, Principal Investigator, Rambam Health Care Campus
  • Overall Contact(s)
    • Yaniv Zipori, M.D, +972 58 7966963, y_zipori@rambam.health.gov.il

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