Pregnancy PretermE-ALPSNCT03076775
Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
A study of Pregnancy Preterm and Neonatal Hypoglycemia, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Preterm, Neonatal Hypoglycemia, Hyperglycemia Drug Induced
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2017to 19 Nov 2021
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton gestation with no known major fetal anomalies
- Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
- Receiving antenatal betamethasone due to high probability of delivery in late preterm period
Who cannot join
- Pre-gestational or gestational diabetes mellitus
- Maternal contraindication to insulin
- Planned outpatient treatment with antenatal betamethasone
- Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Fetal Metabolic Consequences of Late Preterm Steroid Exposure
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.
This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?
Read the detailed description
Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:
There is a fundamental gap in understanding the adverse metabolic effects of antenatal late preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal respiratory complications compared with placebo. However, those neonates exposed to BMZ were also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised concern among both obstetricians and neonatologists and remains an important knowledge gap to be filled. The rationale for the proposed research is that steroid-induced maternal hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in neonates that are delivered during this time-period. Thus, the fetal metabolic consequences and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented by achieving maternal euglycemia prior to delivery.
This protocol describes a randomized clinical trial to evaluate whether screening for and treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal hypoglycemia and improving short-term neonatal outcomes.
This study was formerly approved as Institutional Review Board #16-3200.
- Being tested
- Maternal glycemic control
- Keywords
- Betamethasone, Late preterm, Steroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal glycemic controlOther
Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days. Receives: Other: Maternal glycemic control |
| Usual Care | No intervention | Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Cord Blood C-peptide
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
Measured: At delivery
Secondary outcomes (14)
Umbilical Cord Blood Cortisol
Cortisol level (ug/mL) as measure of fetal immune suppression
Measured: At delivery
Umbilical Insulin-Like Growth Factor 1
Insulin-like growth factor 1 level (ng/mL) as a measure of in utero metabolic status
Measured: At delivery
Umbilical Cord Blood Leptin
Leptin level (ng/mL) as measure of fetal adiposity
Measured: At delivery
Neonatal Hypoglycemia
Number of neonates with capillary blood glucose < 40 mg/dL
Measured: After birth, up to 48 hours of life
Neonatal Hypoglycemia Treatment
Number of neonates with hypoglycemia requiring treatment with dextrose gel or dextrose intravenous fluids
Measured: After birth, during hospital admission, assessed up to 28 days
Neonatal Glucose Nadir
Lowest neonatal capillary blood glucose (mg/dL)
Measured: After birth, during hospital admission, assessed up to 28 days
Timing of Neonatal Blood Glucose Nadir
Number of hours after birth when lowest neonatal capillary blood glucose was measured
Measured: After birth, during hospital admission, assessed up to 28 days
Neonatal Intensive Care Unit Admission
Number of neonates admitted to the neonatal intensive care unit for > 24 hours
Measured: Date of delivery to date of discharge from hospital, assessed up to 28 days
Neonatal Intensive Care Unit Length of Stay
Number of days of neonatal intensive care unit stay
Measured: From neonatal intensive care unit admission to discharge, assessed up to 28 days
Neonatal Seizures
Number of neonates who had seizures
Measured: After birth, during hospital admission, assessed up to 28 days
Neonatal Mortality
Number of neonates who died
Measured: After birth, during hospital admission, assessed up to 28 days
Maternal Hyperglycemia
Number of mothers with intrapartum capillary blood glucose >110 mg/dL, fasting capillary blood glucose >95 mg/dL, or 1-hour postprandial capillary blood glucose >140 mg/dL
Measured: For five days after first dose of betamethasone administration
Maternal Insulin Treatment
Number of mothers who received insulin for treatment of hyperglycemia
Measured: For five days after first dose of betamethasone administration
Maternal Hypoglycemia
Number of mothers with capillary blood glucose <60 mg/dL
Measured: For five days after first dose of betamethasone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start8 Jun 2017
- Primary completion18 Feb 2021
- Study completion19 Nov 2021
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 (17)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PretermStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ashley N Battarbee, MD, MSCR, Principal investigator, University of Alabama at BirminghamKim Boggess, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076775
- Sponsor's protocol ID
- 18-1970
- Other IDs
- 1R03HD096188-01
- Acronym
- E-ALPS
- Status last verified
- Dec 2021
- First submitted
- 1 Mar 2017
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected as a part of this trial will only be available to the study team. Protected health information will only be available to the recruiting site in order to complete data abstraction.
Publications
Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita AT, Reddy UM, Saade GR, Rouse DJ, McKenna DS, Clark EA, Thorp JM Jr, Chien EK, Peaceman AM, Gibbs RS, Swamy GK, Norton ME, Casey BM, Caritis SN, Tolosa JE, Sorokin Y, VanDorsten JP, Jain L; NICHD Maternal-Fetal Medicine Units Network. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Apr 7;374(14):1311-20. doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.
PubMed 26842679Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
PubMed 28135188McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73.
PubMed 18165390Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
PubMed 20664042Gilbert WM, Nesbitt TS, Danielsen B. The cost of prematurity: quantification by gestational age and birth weight. Obstet Gynecol. 2003 Sep;102(3):488-92. doi: 10.1016/s0029-7844(03)00617-3.
PubMed 12962929Jolley JA, Rajan PV, Petersen R, Fong A, Wing DA. Effect of antenatal betamethasone on blood glucose levels in women with and without diabetes. Diabetes Res Clin Pract. 2016 Aug;118:98-104. doi: 10.1016/j.diabres.2016.06.005. Epub 2016 Jun 17.
PubMed 27351800Langen ES, Kuperstock JL, Sung JF, Taslimi M, Byrne J, El-Sayed YY. Maternal glucose response to betamethasone administration. Am J Perinatol. 2015 Feb;30(2):143-8. doi: 10.1055/s-0034-1376387. Epub 2014 Jun 10.
PubMed 24915559Shelton SD, Boggess KA, Smith T, Herbert WN. Effect of betamethasone on maternal glucose. J Matern Fetal Neonatal Med. 2002 Sep;12(3):191-5. doi: 10.1080/jmf.12.3.191.195.
PubMed 12530617Refuerzo JS, Garg A, Rech B, Ramin SM, Vidaeff A, Blackwell SC. Continuous glucose monitoring in diabetic women following antenatal corticosteroid therapy: a pilot study. Am J Perinatol. 2012 May;29(5):335-8. doi: 10.1055/s-0031-1295642. Epub 2011 Nov 17.
PubMed 22094918Sifianou P, Thanou V, Karga H. Metabolic and hormonal effects of antenatal betamethasone after 35 weeks of gestation. J Pediatr Pharmacol Ther. 2015 Mar-Apr;20(2):138-43. doi: 10.5863/1551-6776-20.2.138.
PubMed 25964731Obenshain SS, Adam PA, King KC, Teramo K, Raivio KO, Raiha N, Schwartz R. Human fetal insulin response to sustained maternal hyperglycemia. N Engl J Med. 1970 Sep 10;283(11):566-70. doi: 10.1056/NEJM197009102831104. No abstract available.
PubMed 5450610Kuhl C, Andersen GE, Hertel J, Molsted-Pedersen L. Metabolic events in infants of diabetic mothers during first 24 hours after birth. I. Changes in plasma glucose, insulin and glucagon. Acta Paediatr Scand. 1982 Jan;71(1):19-25. doi: 10.1111/j.1651-2227.1982.tb09366.x.
PubMed 6753468American College of Obstetricians and Gynecologists' Committee on Obstetric Practice; Society for Maternal- Fetal Medicine. Committee Opinion No.677: Antenatal Corticosteroid Therapy for Fetal Maturation. Obstet Gynecol. 2016 Oct;128(4):e187-94. doi: 10.1097/AOG.0000000000001715.
PubMed 27661658Society for Maternal-Fetal Medicine (SMFM) Publications Committee. Implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery. Am J Obstet Gynecol. 2016 Aug;215(2):B13-5. doi: 10.1016/j.ajog.2016.03.013. Epub 2016 Mar 15. No abstract available.
PubMed 26992737ACOG Committee on Practice Bulletins. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 60, March 2005. Pregestational diabetes mellitus. Obstet Gynecol. 2005 Mar;105(3):675-85. doi: 10.1097/00006250-200503000-00049. No abstract available.
PubMed 15738045
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Metabolic Consequences of Late Preterm Steroid Exposure
- ClinicalTrials.gov ID
- NCT03076775
- Acronym / sponsor ID
- E-ALPS / 18-1970
- Keywords
- Betamethasone, Late preterm, Steroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.
This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?
Detailed description
Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:
There is a fundamental gap in understanding the adverse metabolic effects of antenatal late preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal respiratory complications compared with placebo. However, those neonates exposed to BMZ were also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised concern among both obstetricians and neonatologists and remains an important knowledge gap to be filled. The rationale for the proposed research is that steroid-induced maternal hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in neonates that are delivered during this time-period. Thus, the fetal metabolic consequences and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented by achieving maternal euglycemia prior to delivery.
This protocol describes a randomized clinical trial to evaluate whether screening for and treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal hypoglycemia and improving short-term neonatal outcomes.
This study was formerly approved as Institutional Review Board #16-3200.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Maternal glycemic controlWomen will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days. |
| Usual Care | No intervention | –Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton gestation with no known major fetal anomalies
- Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
- Receiving antenatal betamethasone due to high probability of delivery in late preterm period
Key exclusion criteria (4 listed)
- Pre-gestational or gestational diabetes mellitus
- Maternal contraindication to insulin
- Planned outpatient treatment with antenatal betamethasone
- Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy
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 |
|---|---|---|
| Maternal glycemic controlMaternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals. | Other | Intervention |
Primary outcome
Umbilical Cord Blood C-peptide
Time frame: At delivery
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
14 secondary outcomes
Umbilical Cord Blood Cortisol
Time frame: At delivery
Umbilical Insulin-Like Growth Factor 1
Time frame: At delivery
Umbilical Cord Blood Leptin
Time frame: At delivery
Neonatal Hypoglycemia
Time frame: After birth, up to 48 hours of life
Neonatal Hypoglycemia Treatment
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Glucose Nadir
Time frame: After birth, during hospital admission, assessed up to 28 days
Timing of Neonatal Blood Glucose Nadir
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Intensive Care Unit Admission
Time frame: Date of delivery to date of discharge from hospital, assessed up to 28 days
Neonatal Intensive Care Unit Length of Stay
Time frame: From neonatal intensive care unit admission to discharge, assessed up to 28 days
Neonatal Seizures
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Mortality
Time frame: After birth, during hospital admission, assessed up to 28 days
Maternal Hyperglycemia
Time frame: For five days after first dose of betamethasone administration
Maternal Insulin Treatment
Time frame: For five days after first dose of betamethasone administration
Maternal Hypoglycemia
Time frame: For five days after first dose of betamethasone administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26842679Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita AT, Reddy UM, Saade GR, Rouse DJ, McKenna DS, Clark EA, Thorp JM Jr, Chien EK, Peaceman AM, Gibbs RS, Swamy GK, Norton ME, Casey BM, Caritis SN, Tolosa JE, Sorokin Y, VanDorsten JP, Jain L; NICHD Maternal-Fetal Medicine Units Network. Antenatal Betamethasone for Women at Risk for Late Preterm Delivery. N Engl J Med. 2016 Apr 7;374(14):1311-20. doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.
- Background: PubMed 28135188Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
- Background: PubMed 18165390McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73.
- Background: PubMed 20664042Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
- Background: PubMed 12962929Gilbert WM, Nesbitt TS, Danielsen B. The cost of prematurity: quantification by gestational age and birth weight. Obstet Gynecol. 2003 Sep;102(3):488-92. doi: 10.1016/s0029-7844(03)00617-3.
- Background: PubMed 27351800Jolley JA, Rajan PV, Petersen R, Fong A, Wing DA. Effect of antenatal betamethasone on blood glucose levels in women with and without diabetes. Diabetes Res Clin Pract. 2016 Aug;118:98-104. doi: 10.1016/j.diabres.2016.06.005. Epub 2016 Jun 17.
- Background: PubMed 24915559Langen ES, Kuperstock JL, Sung JF, Taslimi M, Byrne J, El-Sayed YY. Maternal glucose response to betamethasone administration. Am J Perinatol. 2015 Feb;30(2):143-8. doi: 10.1055/s-0034-1376387. Epub 2014 Jun 10.
- Background: PubMed 12530617Shelton SD, Boggess KA, Smith T, Herbert WN. Effect of betamethasone on maternal glucose. J Matern Fetal Neonatal Med. 2002 Sep;12(3):191-5. doi: 10.1080/jmf.12.3.191.195.
- Background: PubMed 22094918Refuerzo JS, Garg A, Rech B, Ramin SM, Vidaeff A, Blackwell SC. Continuous glucose monitoring in diabetic women following antenatal corticosteroid therapy: a pilot study. Am J Perinatol. 2012 May;29(5):335-8. doi: 10.1055/s-0031-1295642. Epub 2011 Nov 17.
- Background: PubMed 25964731Sifianou P, Thanou V, Karga H. Metabolic and hormonal effects of antenatal betamethasone after 35 weeks of gestation. J Pediatr Pharmacol Ther. 2015 Mar-Apr;20(2):138-43. doi: 10.5863/1551-6776-20.2.138.
- Background: PubMed 5450610Obenshain SS, Adam PA, King KC, Teramo K, Raivio KO, Raiha N, Schwartz R. Human fetal insulin response to sustained maternal hyperglycemia. N Engl J Med. 1970 Sep 10;283(11):566-70. doi: 10.1056/NEJM197009102831104. No abstract available.
- Background: PubMed 6753468Kuhl C, Andersen GE, Hertel J, Molsted-Pedersen L. Metabolic events in infants of diabetic mothers during first 24 hours after birth. I. Changes in plasma glucose, insulin and glucagon. Acta Paediatr Scand. 1982 Jan;71(1):19-25. doi: 10.1111/j.1651-2227.1982.tb09366.x.
- Individual participant dataSharing planned: No. Data collected as a part of this trial will only be available to the study team. Protected health information will only be available to the recruiting site in order to complete data abstraction.
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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.
Ashley N Battarbee, MD, MSCR principal investigator
University of Alabama at Birmingham
Kim Boggess, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pregnancy Preterm and Neonatal Hypoglycemia, run by University of North Carolina, Chapel Hill at 2 sites 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 3 inclusion and 4 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 26 Jan 2022). 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?
Umbilical Cord Blood C-peptide (time frame: At delivery). 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 NCT03076775, which also lists 17 linked publications.
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 26 Jan 2022.