NCT03702959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 8, 2018

Last Update Submit

October 10, 2018

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of neonatal hypoglycemia

    Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time

    7 years

Study Arms (4)

Betamethasone group 1

Betamethasone Group 1 (5am-11am)

Drug: Betamethasone

Betamethasone Group 2

Betamethasone Group 2 (11am-5pm)

Drug: Betamethasone

Betamethasone Group 3

Betamethasone Group 3 (5pm-11pm)

Drug: Betamethasone

Betamethasone Group 4

Betamethasone Group 4 (11pm-5am).

Drug: Betamethasone

Interventions

BetamethasoneDRUG

Corticosteroids

Betamethasone Group 2Betamethasone Group 3Betamethasone Group 4Betamethasone group 1

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women and their newborns
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a retrospective study at Rambam Health Care Campus.

You may qualify if:

  • women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Yaniv Zipori, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaniv Zipori, M.D

CONTACT

+972 58 7966963y_zipori@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 11, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

IL(1)