Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03702959
• Other study ID #: 0205 - 18 - RMB
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2018
• Source: Rambam Health Care Campus
• Contact: Yaniv Zipori, M.D
• Phone: +972 58 7966963
• Email: y_zipori[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Betamethasone
Corticosteroids

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neonatal hypoglycemia	Incidence of neonatal hypoglycemia, glucose ? 40 mg/dL at any time	7 years