HypoglycemiaNCT03702959
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia
An observational study of Hypoglycemia, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Betamethasone
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2018to 1 Mar 2020
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective study at Rambam Health Care Campus.
Who may be able to join
- women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing
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.
Read the 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.
- Conditions
- Hypoglycemia
- Being tested
- Betamethasone
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone group 1 | Betamethasone Group 1 (5am-11am) Receives: Drug: Betamethasone | |
| Betamethasone Group 2 | Betamethasone Group 2 (11am-5pm) Receives: Drug: Betamethasone | |
| Betamethasone Group 3 | Betamethasone Group 3 (5pm-11pm) Receives: Drug: Betamethasone | |
| Betamethasone Group 4 | Betamethasone Group 4 (11pm-5am). Receives: Drug: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal hypoglycemia
Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaniv Zipori MD, Rambam Health Care Campus
- Investigators
- Yaniv Zipori, M.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702959
- Sponsor's protocol ID
- 0205 - 18 - RMB
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is expected to be published after completion
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing
- ClinicalTrials.gov ID
- NCT03702959
- Acronym / sponsor ID
- 0205 - 18 - RMB
- Conditions
- Hypoglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Betamethasone group 1 | – | Drug: BetamethasoneBetamethasone Group 1 (5am-11am) |
| Betamethasone Group 2 | – | Drug: BetamethasoneBetamethasone Group 2 (11am-5pm) |
| Betamethasone Group 3 | – | Drug: BetamethasoneBetamethasone Group 3 (5pm-11pm) |
| Betamethasone Group 4 | – | Drug: BetamethasoneBetamethasone Group 4 (11pm-5am). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective study at Rambam Health Care Campus.
Key inclusion criteria (1 listed)
- women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetamethasoneCorticosteroids | Drug | Betamethasone Group 2, Betamethasone Group 3, Betamethasone Group 4, Betamethasone group 1 |
Primary outcome
Incidence of neonatal hypoglycemia
Time frame: 7 years
Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Undecided. The study is expected to be published after completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaniv Zipori, M.D principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaniv Zipori, M.D (+972 58 7966963, y_zipori@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neonatal hypoglycemia (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.