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Trial record 16 of 272 for:    Betamethasone

Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

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ClinicalTrials.gov Identifier: NCT03702959
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yaniv Zipori MD, Rambam Health Care Campus

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 7 Years
Official Title: Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : March 1, 2020


Group/Cohort 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




Primary Outcome Measures :
  1. Incidence of neonatal hypoglycemia [ Time Frame: 7 years ]
    Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women and their newborns
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a retrospective study at Rambam Health Care Campus.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702959


Contacts
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Contact: Yaniv Zipori, M.D +972 58 7966963 y_zipori@rambam.health.gov.il

Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Yaniv Zipori, M.D Rambam Health Care Campus

Additional Information:

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Responsible Party: Yaniv Zipori MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03702959     History of Changes
Other Study ID Numbers: 0205 - 18 - RMB
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study is expected to be published after completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents