Diabetes Mellitus in PregnancyNCT04672031
Glycemic Targets for Pregnant Women With GDM and T2DM
A study testing Glycemic Targets in people with Diabetes Mellitus in Pregnancy and Diabetes, Gestational, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. 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
- Diabetes Mellitus in Pregnancy, Diabetes, Gestational, Diabetes Mellitus, Type 2
- What is being tested?
- Glycemic Targets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to Jul 2023
- 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
- Pregnant women with a singleton gestation
- 18 years or older
- Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes
Who cannot join
- Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
- Type 1 diabetes
- Diabetic retinopathy
- Diabetic nephropathy
- Diabetic vasculopathy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Los Angeles County + University of Southern California Medical Center (LAC+USC)
Los Angeles, California, 90033
Michelle T Nguyen, MD, 323-409-4084, michelle.nguyen3@med.usc.edu
About this study
Official title: Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.
- Being tested
- Glycemic Targets
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic TargetsOther
The intervention is glycemic targets that are lower than those currently recommended by ADA and ACOG: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL instead of fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Patients in the control arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL (i.e. conventional targets). Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist. |
| Interventional Arm | Experimental | Patients in the experimental arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist. Receives: Other: Glycemic Targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in birth weight
250-gram difference in birth weight
Measured: 41 weeks gestation
Secondary outcomes (55)
Total prenatal care visits
Total number of prenatal care visits during pregnancy
Measured: 41 weeks gestation
Prenatal care visits after enrollment
Number of prenatal care visits after enrollment
Measured: 41 weeks gestation
Prenatal care visits: log/glucometer
Number of prenatal care visits with log/glucometer available for RN or MD to review
Measured: 41 weeks gestation
Prenatal care visits: targets met
Number of prenatal care visits in which patient met blood sugar targets
Measured: 41 weeks gestation
Prenatal care visits: intervention
Number of prenatal care visits in which an intervention for blood sugars was recommended (e.g. starting medication or changing medication dose)
Measured: 41 weeks gestation
Symptomatic hypoglycemia
Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)
Measured: 41 weeks gestation
Asymptomatic hypoglycemia
Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA)
Measured: 41 weeks gestation
A1c enrollment
Hemoglobin A1c at the time of enrollment
Measured: At time of enrollment (up to 34 weeks gestation)
A1c 36 weeks
Hemoglobin A1c at 36 weeks gestational age
Measured: At 36 weeks gestational age
Lowest recorded blood sugar
Lowest recorded blood sugar during prenatal care
Measured: 41 weeks gestation
Highest recorded blood sugar
Highest recorded blood sugar during prenatal care
Measured: 41 weeks gestation
Average recorded blood sugar
Average recorded blood sugar during prenatal care
Measured: 41 weeks gestation
Weekly compliance
Average number of blood sugar checks actually performed each week
Measured: 41 weeks gestation
Weekly target assessment
% of blood sugars within goal each week
Measured: 41 weeks gestation
Diabetes medication
Did the patient need diabetes medication (including oral agents and insulin) during antepartum period?
Measured: 41 weeks gestation
Intrapartum insulin
Did the patient need insulin during the intrapartum period?
Measured: From onset of induction/labor until delivery
Gestational weight gain
Total weight gain during pregnancy in kilograms
Measured: 41 weeks gestation
Antepartum admission
Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication?
Measured: 41 weeks gestation
Corticosteroids
Did the patient receive antenatal corticosteroid treatment?
Measured: 41 weeks gestation
Oligohydramnios
Amniotic fluid index <5 cm or maximum vertical pocket <2cm
Measured: 41 weeks gestation
Polyhydramnios
Amniotic fluid index >24cm or maximum vertical pocket >8cm
Measured: 41 weeks gestation
Fetal growth restriction
Ultrasonographic estimated fetal weight or abdominal circumference <10% for gestational ag
Measured: 41 weeks gestation
Gestational age at delivery
Gestational age at delivery
Measured: During intrapartum admission to Labor & Delivery
Induction of labor
Did the patient undergo induction of labor?
Measured: During intrapartum admission to Labor & Delivery
Mode of delivery
primary cesarean section, repeat cesarean section, vaginal delivery, vaginal delivery with vacuum, vaginal delivery with forceps
Measured: During intrapartum admission to Labor & Delivery
Cesarean indication
If the patient had cesarean delivery, what was the indication?
Measured: During intrapartum admission to Labor & Delivery
TOLAC
Did the patient attempt a trial of labor after cesarean?
Measured: During intrapartum admission to Labor & Delivery
Blood loss
Quantitative blood loss (or estimated if quantitative is unknown) in cc's
Measured: During intrapartum admission to Labor & Delivery
3rd or 4th degree laceration
3rd or 4th degree perineal laceration
Measured: During intrapartum admission to Labor & Delivery
PIH
Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome)
Measured: From 20 weeks gestation until 30 days postpartum
Hypertensive emergency
Did the patient have severe-range blood pressures require antihypertensive medication?
Measured: From conception until 30 days postpartum
Chorioamnionitis
Chorioamnionitis
Measured: During intrapartum admission to Labor & Delivery
Endometritis
Endometritis
Measured: Within 30 days postpartum
VTE
Venous thromboembolism: deep venous thrombosis or pulmonary embolism
Measured: From conception until 30 days postpartum
Length of stay (maternal)
Length of hospital admission for labor, delivery, and postpartum
Measured: From admission to Labor & Delivery until discharge from postpartum
Postpartum readmission
Did the patient get readmitted within 30 days of delivery?
Measured: Within 30 days postpartum
Postpartum wound complication
Cesarean wound infection of dehiscence, perineal laceration breakdown
Measured: Within 30 days postpartum
Cardiac complications
Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy?
Measured: From conception until 30 days postpartum
Seizures
Did any maternal seizures occur during the pregnancy or postpartum?
Measured: From conception until 30 days postpartum
Macrosomia
Birth weight >4000 grams
Measured: Within 24 hours of birth
LGA
Large for gestational age (birth weight ≥90% for gestational age)
Measured: Within 24 hours of birth
SGA
Small for gestational age (birth weight <10% for gestational age)
Measured: Within 24 hours of birth
Shoulder dystocia
Shoulder dystocia
Measured: During intrapartum admission to Labor & Delivery
Apgar
5-minute Apgar score
Measured: 5 minutes after birth
Cord gas pH <7.0
Did the baby have a cord blood gas pH <7.0?
Measured: Within 24 hours of birth
Base excess
What was the base excess on the cord blood gas?
Measured: Within 24 hours of birth
Neonatal blood glucose
What was the neonatal serum blood glucose at birth?
Measured: Within 24 hours of birth
RDS
Neonatal respiratory distress syndrome
Measured: Within 30 days of delivery
TTN
Transient tachypnea of the newborn
Measured: Within 30 days of delivery
Hyperbilirubinemia
Neonatal hyperbilirubinemia (as defined in AAP 2004 Clinical Practice Guideline "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation")
Measured: Within 30 days of delivery
Neonatal sepsis
Neonatal sepsis
Measured: Within 30 days of delivery
NICU
NICU admission
Measured: Within 30 days of delivery
Length of stay (neonatal)
How many days after birth did the neonate stay in the hospital?
Measured: From birth until discharge (up to 1 year)
Congenital anomaly
Congenital anomaly
Measured: Within 30 days of delivery
IUFD or stillbirth
Intrauterine fetal demise or stillbirth
Measured: From conception until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start8 Jul 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible women will be randomized at a 1:1 ratio (using block randomization) into either the control arm or the intervention arm. It is understood that study participants, physicians, and nurse-educators cannot be blinded to group allocation. The randomization process will proceed as follows. A primary randomization model assigning patients to the "New Target" versus the "Standard Target" will be created for the one center (LAC+USC), and permuted-block randomization with random allocation will be used. The investigators will be blinded to the block size. The generation of randomization codes will be performed using SAS statistical software, v. 9.3, Cary, NC. A validation test will be performed to assure that treatment balance is achieved within the entire study.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Grubbs, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672031
- Sponsor's protocol ID
- APP-20-06210
- Status last verified
- May 2023
- First submitted
- 8 Dec 2020
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
PubMed 31856124ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047ACOG Practice Bulletin No. 190 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):406-408. doi: 10.1097/AOG.0000000000002498.
PubMed 29370044Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
PubMed 9704245Hernandez TL. Glycemic targets in pregnancies affected by diabetes: historical perspective and future directions. Curr Diab Rep. 2015 Jan;15(1):565. doi: 10.1007/s11892-014-0565-2.
PubMed 25398204Fraser R. Diabetic control in pregnancy and intrauterine growth of the fetus. Br J Obstet Gynaecol. 1995 Apr;102(4):275-7. doi: 10.1111/j.1471-0528.1995.tb09130.x. No abstract available.
PubMed 7612507Dandona P, Besterman HS, Freedman DB, Boag F, Taylor AM, Beckett AG. Macrosomia despite well-controlled diabetic pregnancy. Lancet. 1984 Mar 31;1(8379):737. doi: 10.1016/s0140-6736(84)92248-7. No abstract available.
PubMed 6143065Combs CA, Gunderson E, Kitzmiller JL, Gavin LA, Main EK. Relationship of fetal macrosomia to maternal postprandial glucose control during pregnancy. Diabetes Care. 1992 Oct;15(10):1251-7. doi: 10.2337/diacare.15.10.1251.
PubMed 1425084Hernandez TL, Friedman JE, Van Pelt RE, Barbour LA. Patterns of glycemia in normal pregnancy: should the current therapeutic targets be challenged? Diabetes Care. 2011 Jul;34(7):1660-8. doi: 10.2337/dc11-0241. No abstract available.
PubMed 21709299Thompson DM, Dansereau J, Creed M, Ridell L. Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. Obstet Gynecol. 1994 Mar;83(3):362-6.
PubMed 8127526Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
PubMed 7148898Buchanan TA, Kjos SL, Montoro MN, Wu PY, Madrilejo NG, Gonzalez M, Nunez V, Pantoja PM, Xiang A. Use of fetal ultrasound to select metabolic therapy for pregnancies complicated by mild gestational diabetes. Diabetes Care. 1994 Apr;17(4):275-83. doi: 10.2337/diacare.17.4.275.
PubMed 8026282Kjos SL, Schaefer-Graf U, Sardesi S, Peters RK, Buley A, Xiang AH, Bryne JD, Sutherland C, Montoro MN, Buchanan TA. A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. Diabetes Care. 2001 Nov;24(11):1904-10. doi: 10.2337/diacare.24.11.1904.
PubMed 11679455American Diabetes Association. 14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S183-S192. doi: 10.2337/dc20-S014.
PubMed 31862757American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.
PubMed 15231951
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04672031
- Acronym / sponsor ID
- APP-20-06210
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 17 Dec 2020 (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 purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible women will be randomized at a 1:1 ratio (using block randomization) into either the control arm or the intervention arm. It is understood that study participants, physicians, and nurse-educators cannot be blinded to group allocation. The randomization process will proceed as follows. A primary randomization model assigning patients to the "New Target" versus the "Standard Target" will be created for the one center (LAC+USC), and permuted-block randomization with random allocation will be used. The investigators will be blinded to the block size. The generation of randomization codes will be performed using SAS statistical software, v. 9.3, Cary, NC. A validation test will be performed to assure that treatment balance is achieved within the entire study.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Patients in the control arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL (i.e. conventional targets). Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist. |
| Interventional Arm | Experimental | Other: Glycemic TargetsPatients in the experimental arm will be instructed to check blood sugars seven times per day: fasting, pre-prandial, and 1 hour after each meal. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. Patients who do not achieve glycemic goals with diet and exercise will be started on medical therapy (metformin or insulin) at the discretion of a maternal-fetal medicine subspecialist and endocrinologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women with a singleton gestation
- 18 years or older
- Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes
Key exclusion criteria (5 listed)
- Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
- Type 1 diabetes
- Diabetic retinopathy
- Diabetic nephropathy
- Diabetic vasculopathy
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 |
|---|---|---|
| Glycemic TargetsThe intervention is glycemic targets that are lower than those currently recommended by ADA and ACOG: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL instead of fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. | Other | Interventional Arm |
Primary outcome
Difference in birth weight
Time frame: 41 weeks gestation
250-gram difference in birth weight
55 secondary outcomes
Total prenatal care visits
Time frame: 41 weeks gestation
Prenatal care visits after enrollment
Time frame: 41 weeks gestation
Prenatal care visits: log/glucometer
Time frame: 41 weeks gestation
Prenatal care visits: targets met
Time frame: 41 weeks gestation
Prenatal care visits: intervention
Time frame: 41 weeks gestation
Symptomatic hypoglycemia
Time frame: 41 weeks gestation
Asymptomatic hypoglycemia
Time frame: 41 weeks gestation
A1c enrollment
Time frame: At time of enrollment (up to 34 weeks gestation)
A1c 36 weeks
Time frame: At 36 weeks gestational age
Lowest recorded blood sugar
Time frame: 41 weeks gestation
Highest recorded blood sugar
Time frame: 41 weeks gestation
Average recorded blood sugar
Time frame: 41 weeks gestation
Weekly compliance
Time frame: 41 weeks gestation
Weekly target assessment
Time frame: 41 weeks gestation
Diabetes medication
Time frame: 41 weeks gestation
Intrapartum insulin
Time frame: From onset of induction/labor until delivery
Gestational weight gain
Time frame: 41 weeks gestation
Antepartum admission
Time frame: 41 weeks gestation
Corticosteroids
Time frame: 41 weeks gestation
Oligohydramnios
Time frame: 41 weeks gestation
Polyhydramnios
Time frame: 41 weeks gestation
Fetal growth restriction
Time frame: 41 weeks gestation
Gestational age at delivery
Time frame: During intrapartum admission to Labor & Delivery
Induction of labor
Time frame: During intrapartum admission to Labor & Delivery
Mode of delivery
Time frame: During intrapartum admission to Labor & Delivery
Cesarean indication
Time frame: During intrapartum admission to Labor & Delivery
TOLAC
Time frame: During intrapartum admission to Labor & Delivery
Blood loss
Time frame: During intrapartum admission to Labor & Delivery
3rd or 4th degree laceration
Time frame: During intrapartum admission to Labor & Delivery
PIH
Time frame: From 20 weeks gestation until 30 days postpartum
Hypertensive emergency
Time frame: From conception until 30 days postpartum
Chorioamnionitis
Time frame: During intrapartum admission to Labor & Delivery
Endometritis
Time frame: Within 30 days postpartum
VTE
Time frame: From conception until 30 days postpartum
Length of stay (maternal)
Time frame: From admission to Labor & Delivery until discharge from postpartum
Postpartum readmission
Time frame: Within 30 days postpartum
Postpartum wound complication
Time frame: Within 30 days postpartum
Cardiac complications
Time frame: From conception until 30 days postpartum
Seizures
Time frame: From conception until 30 days postpartum
Macrosomia
Time frame: Within 24 hours of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 31856124Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Background: PubMed 29370044ACOG Practice Bulletin No. 190 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):406-408. doi: 10.1097/AOG.0000000000002498.
- Background: PubMed 9704245Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
- Background: PubMed 25398204Hernandez TL. Glycemic targets in pregnancies affected by diabetes: historical perspective and future directions. Curr Diab Rep. 2015 Jan;15(1):565. doi: 10.1007/s11892-014-0565-2.
- Background: PubMed 7612507Fraser R. Diabetic control in pregnancy and intrauterine growth of the fetus. Br J Obstet Gynaecol. 1995 Apr;102(4):275-7. doi: 10.1111/j.1471-0528.1995.tb09130.x. No abstract available.
- Background: PubMed 6143065Dandona P, Besterman HS, Freedman DB, Boag F, Taylor AM, Beckett AG. Macrosomia despite well-controlled diabetic pregnancy. Lancet. 1984 Mar 31;1(8379):737. doi: 10.1016/s0140-6736(84)92248-7. No abstract available.
- Background: PubMed 1425084Combs CA, Gunderson E, Kitzmiller JL, Gavin LA, Main EK. Relationship of fetal macrosomia to maternal postprandial glucose control during pregnancy. Diabetes Care. 1992 Oct;15(10):1251-7. doi: 10.2337/diacare.15.10.1251.
- Background: PubMed 21709299Hernandez TL, Friedman JE, Van Pelt RE, Barbour LA. Patterns of glycemia in normal pregnancy: should the current therapeutic targets be challenged? Diabetes Care. 2011 Jul;34(7):1660-8. doi: 10.2337/dc11-0241. No abstract available.
- Background: PubMed 8127526Thompson DM, Dansereau J, Creed M, Ridell L. Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. Obstet Gynecol. 1994 Mar;83(3):362-6.
- Background: PubMed 7148898Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
- Background: PubMed 8026282Buchanan TA, Kjos SL, Montoro MN, Wu PY, Madrilejo NG, Gonzalez M, Nunez V, Pantoja PM, Xiang A. Use of fetal ultrasound to select metabolic therapy for pregnancies complicated by mild gestational diabetes. Diabetes Care. 1994 Apr;17(4):275-83. doi: 10.2337/diacare.17.4.275.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic Targets in people with Diabetes Mellitus in Pregnancy and Diabetes, Gestational, run by University of Southern California 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 3 inclusion and 5 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 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brendan H Grubbs, MD (323-409-3306, brendan.grubbs@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in birth weight (time frame: 41 weeks gestation). 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 NCT04672031, which also lists 16 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 11 May 2023.