Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing

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.

Study Overview

• Status: Unknown
• Conditions: Hypoglycemia
• Intervention / Treatment: Drug: Betamethasone

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Yaniv Zipori, M.D; Phone Number: +972 58 7966963; Email: y_zipori@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This is a retrospective study at Rambam Health Care Campus.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Betamethasone group 1; Betamethasone Group 1 (5am-11am)	Drug: Betamethasone; Corticosteroids
Betamethasone Group 2; Betamethasone Group 2 (11am-5pm)	Drug: Betamethasone; Corticosteroids
Betamethasone Group 3; Betamethasone Group 3 (5pm-11pm)	Drug: Betamethasone; Corticosteroids
Betamethasone Group 4; Betamethasone Group 4 (11pm-5am).	Drug: Betamethasone; Corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of neonatal hypoglycemia	Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time	7 years

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Yaniv Zipori, M.D, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 0205 - 18 - RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study is expected to be published after completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No