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Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03702959
Enrollment
1000
Registered
2018-10-11
Start date
2018-10-01
Completion date
2020-03-01
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia

Brief summary

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.

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

DRUGBetamethasone

Corticosteroids

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of neonatal hypoglycemia7 yearsIncidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time

Countries

Israel

Contacts

Primary ContactYaniv Zipori, M.D
y_zipori@rambam.health.gov.il+972 58 7966963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026