NCT03702959

Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Betamethasone	Corticosteroids

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-10-01
• Completion: 2020-03-01
• First posted: 2018-10-11
• Last updated: 2018-10-11

Locations

1 site across 1 country: Israel