Neonatal HypoglycemiaNCT06373432
Frequency of Glucose Monitoring in Labor
A study testing Fingerstick in people with Neonatal Hypoglycemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Fingerstick
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 30 May 2025
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All female patients of reproductive age who have the diagnosis GDM
- Patient with singleton gestation presenting in labor or for induction
Who cannot join
- Patients below the age of 18
- Multiple gestation pregnancy
- Patients undergoing scheduled c-section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrapartum Glucose Monitoring of GDM: A Randomized Controlled Trial
The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Fingerstick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingerstickOther
Fingerstick to check glucose value during labor.
| Study group | Role | What they receive |
|---|---|---|
| Infrequent testing | Experimental | Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater) Receives: Other: Fingerstick |
| Frequent testing | Placebo comparator | Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater) Receives: Other: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hypoglycemia
Glucose values of neonate measured in mg/dL
Measured: end of study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Owens, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Owens, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373432
- Sponsor's protocol ID
- STUDY-22-01607
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Glucose Monitoring of GDM: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06373432
- Acronym / sponsor ID
- STUDY-22-01607
- Conditions
- Neonatal Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 18 Apr 2024 (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.
The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrequent testing | Experimental | Other: FingerstickFinger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater) |
| Frequent testing | Placebo comparator | Other: FingerstickFinger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All female patients of reproductive age who have the diagnosis GDM
- Patient with singleton gestation presenting in labor or for induction
Key exclusion criteria (3 listed)
- Patients below the age of 18
- Multiple gestation pregnancy
- Patients undergoing scheduled c-section
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 |
|---|---|---|
| FingerstickFingerstick to check glucose value during labor. | Other | Frequent testing, Infrequent testing |
Primary outcome
Neonatal Hypoglycemia
Time frame: end of study at 6 months
Glucose values of neonate measured in mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Thomas Owens, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fingerstick in people with Neonatal Hypoglycemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 2 Jul 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Hypoglycemia (time frame: end of study at 6 months). 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 2 Jul 2025.