Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Rambam Health Care Campus

Status: Unknown

Conditions: Hypoglycemia

Treatments: Drug: Betamethasone

Study type: Observational

Funder types: Other

Identifiers

NCT03702959

0205 - 18 - RMB

Details and patient eligibility

About

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 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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 4 patient groups

Betamethasone group 1

Description:

Betamethasone Group 1 (5am-11am)

Treatment:

Drug: Betamethasone

Betamethasone Group 2

Description:

Betamethasone Group 2 (11am-5pm)

Treatment:

Drug: Betamethasone

Betamethasone Group 3

Description:

Betamethasone Group 3 (5pm-11pm)

Treatment:

Drug: Betamethasone

Betamethasone Group 4

Description:

Betamethasone Group 4 (11pm-5am).

Treatment:

Drug: Betamethasone