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 Title of Study: “Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It’s All About Timing”
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Other
- Study Primary Completion Date: October 1, 2019
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.
- Drug: Betamethasone
Arms, Groups and Cohorts
- Betamethasone group 1
- Betamethasone Group 1 (5am-11am)
- Betamethasone Group 2
- Betamethasone Group 2 (11am-5pm)
- Betamethasone Group 3
- Betamethasone Group 3 (5pm-11pm)
- Betamethasone Group 4
- Betamethasone Group 4 (11pm-5am).
Clinical Trial Outcome Measures
- Incidence of neonatal hypoglycemia
- Time Frame: 7 years
- Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time
Participating in This Clinical Trial
• women between 24 – 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution
- 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.
Gender Eligibility: Female
Pregnant women and their newborns
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Rambam Health Care Campus
- Provider of Information About this Clinical Study
- Principal Investigator: Yaniv Zipori MD, Principal Investigator – Rambam Health Care Campus
- Overall Official(s)
- Yaniv Zipori, M.D, Principal Investigator, Rambam Health Care Campus
- Overall Contact(s)
- Yaniv Zipori, M.D, +972 58 7966963, email@example.com
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