Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT03702959

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

58.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia	Drug: Betamethasone

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Betamethasone group 1 Betamethasone Group 1 (5am-11am)	Drug: Betamethasone Corticosteroids
Betamethasone Group 2 Betamethasone Group 2 (11am-5pm)	Drug: Betamethasone Corticosteroids
Betamethasone Group 3 Betamethasone Group 3 (5pm-11pm)	Drug: Betamethasone Corticosteroids
Betamethasone Group 4 Betamethasone Group 4 (11pm-5am).	Drug: Betamethasone Corticosteroids

Outcome Measures

Primary Outcome Measures

Incidence of neonatal hypoglycemia [7 years]
Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam health care campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Yaniv Zipori, M.D, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yaniv Zipori MD, Principal Investigator, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT03702959

Other Study ID Numbers:

0205 - 18 - RMB

First Posted:

Oct 11, 2018

Last Update Posted:

Oct 11, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoglycemia

Betamethasone

Study Results

No Results Posted as of Oct 11, 2018