Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

NCT ID: NCT03702959

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Betamethasone group 1

Betamethasone Group 1 (5am-11am)

Betamethasone

Intervention Type DRUG

Corticosteroids

Betamethasone Group 2

Betamethasone Group 2 (11am-5pm)

Betamethasone

Intervention Type DRUG

Corticosteroids

Betamethasone Group 3

Betamethasone Group 3 (5pm-11pm)

Betamethasone

Intervention Type DRUG

Corticosteroids

Betamethasone Group 4

Betamethasone Group 4 (11pm-5am).

Betamethasone

Intervention Type DRUG

Corticosteroids

Interventions

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Betamethasone

Corticosteroids

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Yaniv Zipori MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaniv Zipori, M.D

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yaniv Zipori, M.D

Role: CONTACT

+972 58 7966963

Other Identifiers

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0205 - 18 - RMB

Identifier Type: -

Identifier Source: org_study_id

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