Gestational DiabetesNCT05430204
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
A study testing Group 1: one-hour GCT and Group 2: CGM placement in people with Gestational Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Group 1: one-hour GCT and Group 2: CGM placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,628 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 24-30 weeks gestation undergoing GDM screening
Who cannot join
- Known diagnosis of Type I and II DM
- History of bariatric surgery
- Major fetal anomalies
- Unwilling to use CGM for GDM screening
- Incarcerated subjects
- History of allergic reaction to any of CGM metals or adhesives in contact with the skin
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
- Conditions
- Gestational Diabetes
- Being tested
- Group 1: one-hour GCT, Group 2: CGM placement
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: one-hour GCTDevice
Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.
Group 2: CGM placementDevice
CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
- Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or
- Average glucose≥130 mg/dL or
- Any glucose value ≥200 mg/dL
| Study group | Role | What they receive |
|---|---|---|
| one-hour Glucose tolerance test (GCT) | Active comparator | Not described Receives: Device: Group 1: one-hour GCT |
| CGM screening | Experimental | Not described Receives: Device: Group 2: CGM placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Neonates That Show Composite Adverse Neonatal Outcome
Composite adverse neonatal outcome include one or more of the following:
- Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
- Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
- Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
- Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
- Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
- Fetal or neonatal death (within 28 days of birth)
Measured: From birth to about 28 days of life.
Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)
LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Measured: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
Measured: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Measured: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia
Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
Measured: from birth to discharge (about 3-15 days)
Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress
Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
Measured: from birth to discharge (about 3-15 days)
Number of Fetal or Neonatal Deaths
Measured: within 28 days of birth
Secondary outcomes (31)
Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Use Diabetic Medication During Pregnancy
diabetic medication is described as any glycemic control agent
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly
Measured: From enrollment to delivery
Number of Women That Have Preterm Birth
Pre term birth is described as delivery less than 37 weeks of gestation
Measured: at time of birth
Number of Women That Undergo Induced Labor
Measured: at time of birth
Number of Women That Experience Pregnancy Induced Hypertension
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Eclampsia: Seizures
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women Admitted Due to Poor Glucose Control
Measured: From enrollment up to delivery
Number of Women With Primary Cesarean Section
Measured: at time of birth
Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Endometritis
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Wound Complications
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Diagnosis of Type 2 Diabetes During Postpartum
Measured: birth to 6 weeks postpartum
Number of Neonates With Apgar Score Less Than 7
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Measured: 5 minutes after birth
Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: birth to time of discharge from NICU (about 15 days)
NICU Length of Stay
Measured: birth to time of discharge from NICU (about 15 days)
Number of Neonates With Hyperbilirubinemia Requiring Phototherapy
Measured: birth to discharge (about 3-15 days)
Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy
Measured: birth to discharge (about 3-15 days)
Number of Neonates That Are Small for Gestational Age
Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)
Measured: at time of birth
Number of Participants Who Breastfed Their Babies
Measured: from birth to 6 weeks postpartum
Number of Participants Who Formula Fed Their Babies
Measured: from birth to 6 weeks postpartum
Maximum Bilirubin Level - Neonates
Measured: birth to discharge (about 3 -15 days)
Cord Arterial pH
Measured: at time of birth
Number of Neonates With Polycythemia
Measured: birth to discharge (about 3 -15 days)
Number of Women That Experience Preeclampsia With Severe Features
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Super Imposed Preeclampsia
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Need for Blood Transfusion
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester
Measured: Third trimester (≥28 weeks gestation through delivery)
Number of Women That Experience HELLP Syndrome
HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines.
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Cord Venous pH
Measured: at time of birth
Total Health System Costs for Mothers and Infants
Measured: From enrollment to 6 weeks post partum, on average 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start7 Mar 2023
- Primary completion2 Aug 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,628 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Michal Fishel Bartal, The University of Texas Health Science Center, Houston
- Investigators
- Michal Fishel Bartal, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430204
- Sponsor's protocol ID
- HSC-MS-22-0153
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2022
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fishel Bartal M, Ashby Cornthwaite J, Ghafir D, Ward C, Nazeer SA, Blackwell SC, Pedroza C, Chauhan SP, Sibai BM. Continuous glucose monitoring in individuals undergoing gestational diabetes screening. Am J Obstet Gynecol. 2023 Oct;229(4):441.e1-441.e14. doi: 10.1016/j.ajog.2023.04.021. Epub 2023 Apr 23.
PubMed 37088275
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
- ClinicalTrials.gov ID
- NCT05430204
- Acronym / sponsor ID
- HSC-MS-22-0153
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,628 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 4 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-hour Glucose tolerance test (GCT) | Active comparator | Device: Group 1: one-hour GCT |
| CGM screening | Experimental | Device: Group 2: CGM placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 24-30 weeks gestation undergoing GDM screening
Key exclusion criteria (6 listed)
- Known diagnosis of Type I and II DM
- History of bariatric surgery
- Major fetal anomalies
- Unwilling to use CGM for GDM screening
- Incarcerated subjects
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 |
|---|---|---|
| Group 1: one-hour GCTGroup I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above. | Device | one-hour Glucose tolerance test (GCT) |
| Group 2: CGM placementCGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group: * Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or * Average glucose≥130 mg/dL or * Any glucose value ≥200 mg/dL | Device | CGM screening |
Primary outcome
Number of Neonates That Show Composite Adverse Neonatal Outcome
Time frame: From birth to about 28 days of life.
Composite adverse neonatal outcome include one or more of the following: * Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) * Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered * Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury * Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy * Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life * Fetal or neonatal death (within 28 days of birth)
Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)
Time frame: at time of birth
LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia
Time frame: at time of birth
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury
Time frame: at time of birth
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia
Time frame: from birth to discharge (about 3-15 days)
Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress
Time frame: from birth to discharge (about 3-15 days)
Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
Number of Fetal or Neonatal Deaths
Time frame: within 28 days of birth
31 secondary outcomes
Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Use Diabetic Medication During Pregnancy
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly
Time frame: From enrollment to delivery
Number of Women That Have Preterm Birth
Time frame: at time of birth
Number of Women That Undergo Induced Labor
Time frame: at time of birth
Number of Women That Experience Pregnancy Induced Hypertension
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Eclampsia: Seizures
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women Admitted Due to Poor Glucose Control
Time frame: From enrollment up to delivery
Number of Women With Primary Cesarean Section
Time frame: at time of birth
Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Endometritis
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Wound Complications
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Diagnosis of Type 2 Diabetes During Postpartum
Time frame: birth to 6 weeks postpartum
Number of Neonates With Apgar Score Less Than 7
Time frame: 5 minutes after birth
Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: birth to time of discharge from NICU (about 15 days)
NICU Length of Stay
Time frame: birth to time of discharge from NICU (about 15 days)
Number of Neonates With Hyperbilirubinemia Requiring Phototherapy
Time frame: birth to discharge (about 3-15 days)
Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy
Time frame: birth to discharge (about 3-15 days)
Number of Neonates That Are Small for Gestational Age
Time frame: at time of birth
Number of Participants Who Breastfed Their Babies
Time frame: from birth to 6 weeks postpartum
Number of Participants Who Formula Fed Their Babies
Time frame: from birth to 6 weeks postpartum
Maximum Bilirubin Level - Neonates
Time frame: birth to discharge (about 3 -15 days)
Cord Arterial pH
Time frame: at time of birth
Number of Neonates With Polycythemia
Time frame: birth to discharge (about 3 -15 days)
Number of Women That Experience Preeclampsia With Severe Features
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Super Imposed Preeclampsia
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Need for Blood Transfusion
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester
Time frame: Third trimester (≥28 weeks gestation through delivery)
Number of Women That Experience HELLP Syndrome
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Cord Venous pH
Time frame: at time of birth
Total Health System Costs for Mothers and Infants
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37088275Fishel Bartal M, Ashby Cornthwaite J, Ghafir D, Ward C, Nazeer SA, Blackwell SC, Pedroza C, Chauhan SP, Sibai BM. Continuous glucose monitoring in individuals undergoing gestational diabetes screening. Am J Obstet Gynecol. 2023 Oct;229(4):441.e1-441.e14. doi: 10.1016/j.ajog.2023.04.021. Epub 2023 Apr 23.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Michal Fishel Bartal, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: one-hour GCT and Group 2: CGM placement in people with Gestational Diabetes, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 6 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 4 Dec 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. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Neonates That Show Composite Adverse Neonatal Outcome (time frame: From birth to about 28 days of life.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430204, which also lists 1 linked publication.
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 4 Dec 2025.