Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

• Conditions: Hypoglycemia
• Interventions: Drug: Betamethasone

• Registration Number: NCT03702959
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Study First Posted: 2018-10-11
• Last Update Posted: 2018-10-11
• Primary Completion: 2019-10-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of neonatal hypoglycemia	7 years	Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel