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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04672031
Other study ID # APP-20-06210
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 8, 2021
Est. completion date July 2023

Study information

Verified date May 2023
Source University of Southern California
Contact Brendan H Grubbs, MD
Phone 323-409-3306
Email brendan.grubbs@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women with a singleton gestation - 18 years or older - Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes Exclusion Criteria: - Diagnosed with gestational diabetes at or beyond 34 weeks gestational age - Type 1 diabetes - Diabetic retinopathy - Diabetic nephropathy - Diabetic vasculopathy

Study Design


Intervention

Other:
Glycemic Targets
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.

Locations

Country Name City State
United States Los Angeles County + University of Southern California Medical Center (LAC+USC) Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (16)

ACOG Practice Bulletin No. 190 Summary: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):406-408. doi: 10.1097/AOG.0000000000002498. — View Citation

ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. — View Citation

American 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. Erratum In: Pediatrics. 2004 Oct;114 — View Citation

American 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. — View Citation

American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70. doi: 10.2337/dc19-S006. — View Citation

Buchanan 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. — View Citation

Carpenter 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. — View Citation

Combs 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. — View Citation

Dandona 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. — View Citation

Fraser 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. — View Citation

Hernandez 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. — View Citation

Hernandez 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. — View Citation

Kjos 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. — View Citation

Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606. — View Citation

Metzger 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. — View Citation

Thompson 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. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in birth weight 250-gram difference in birth weight 41 weeks gestation
Secondary Total prenatal care visits Total number of prenatal care visits during pregnancy 41 weeks gestation
Secondary Prenatal care visits after enrollment Number of prenatal care visits after enrollment 41 weeks gestation
Secondary Prenatal care visits: log/glucometer Number of prenatal care visits with log/glucometer available for RN or MD to review 41 weeks gestation
Secondary Prenatal care visits: targets met Number of prenatal care visits in which patient met blood sugar targets 41 weeks gestation
Secondary 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) 41 weeks gestation
Secondary Symptomatic hypoglycemia Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA) 41 weeks gestation
Secondary Asymptomatic hypoglycemia Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as <70 mg/dL per ADA) 41 weeks gestation
Secondary A1c enrollment Hemoglobin A1c at the time of enrollment At time of enrollment (up to 34 weeks gestation)
Secondary A1c 36 weeks Hemoglobin A1c at 36 weeks gestational age At 36 weeks gestational age
Secondary Lowest recorded blood sugar Lowest recorded blood sugar during prenatal care 41 weeks gestation
Secondary Highest recorded blood sugar Highest recorded blood sugar during prenatal care 41 weeks gestation
Secondary Average recorded blood sugar Average recorded blood sugar during prenatal care 41 weeks gestation
Secondary Weekly compliance Average number of blood sugar checks actually performed each week 41 weeks gestation
Secondary Weekly target assessment % of blood sugars within goal each week 41 weeks gestation
Secondary Diabetes medication Did the patient need diabetes medication (including oral agents and insulin) during antepartum period? 41 weeks gestation
Secondary Intrapartum insulin Did the patient need insulin during the intrapartum period? From onset of induction/labor until delivery
Secondary Gestational weight gain Total weight gain during pregnancy in kilograms 41 weeks gestation
Secondary Antepartum admission Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication? 41 weeks gestation
Secondary Corticosteroids Did the patient receive antenatal corticosteroid treatment? 41 weeks gestation
Secondary Oligohydramnios Amniotic fluid index <5 cm or maximum vertical pocket <2cm 41 weeks gestation
Secondary Polyhydramnios Amniotic fluid index >24cm or maximum vertical pocket >8cm 41 weeks gestation
Secondary Fetal growth restriction Ultrasonographic estimated fetal weight or abdominal circumference <10% for gestational ag 41 weeks gestation
Secondary Gestational age at delivery Gestational age at delivery During intrapartum admission to Labor & Delivery
Secondary Induction of labor Did the patient undergo induction of labor? During intrapartum admission to Labor & Delivery
Secondary Mode of delivery primary cesarean section, repeat cesarean section, vaginal delivery, vaginal delivery with vacuum, vaginal delivery with forceps During intrapartum admission to Labor & Delivery
Secondary Cesarean indication If the patient had cesarean delivery, what was the indication? During intrapartum admission to Labor & Delivery
Secondary TOLAC Did the patient attempt a trial of labor after cesarean? During intrapartum admission to Labor & Delivery
Secondary Blood loss Quantitative blood loss (or estimated if quantitative is unknown) in cc's During intrapartum admission to Labor & Delivery
Secondary 3rd or 4th degree laceration 3rd or 4th degree perineal laceration During intrapartum admission to Labor & Delivery
Secondary PIH Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome) From 20 weeks gestation until 30 days postpartum
Secondary Hypertensive emergency Did the patient have severe-range blood pressures require antihypertensive medication? From conception until 30 days postpartum
Secondary Chorioamnionitis Chorioamnionitis During intrapartum admission to Labor & Delivery
Secondary Endometritis Endometritis Within 30 days postpartum
Secondary VTE Venous thromboembolism: deep venous thrombosis or pulmonary embolism From conception until 30 days postpartum
Secondary Length of stay (maternal) Length of hospital admission for labor, delivery, and postpartum From admission to Labor & Delivery until discharge from postpartum
Secondary Postpartum readmission Did the patient get readmitted within 30 days of delivery? Within 30 days postpartum
Secondary Postpartum wound complication Cesarean wound infection of dehiscence, perineal laceration breakdown Within 30 days postpartum
Secondary Cardiac complications Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy? From conception until 30 days postpartum
Secondary Seizures Did any maternal seizures occur during the pregnancy or postpartum? From conception until 30 days postpartum
Secondary Macrosomia Birth weight >4000 grams Within 24 hours of birth
Secondary LGA Large for gestational age (birth weight =90% for gestational age) Within 24 hours of birth
Secondary SGA Small for gestational age (birth weight <10% for gestational age) Within 24 hours of birth
Secondary Shoulder dystocia Shoulder dystocia During intrapartum admission to Labor & Delivery
Secondary Apgar 5-minute Apgar score 5 minutes after birth
Secondary Cord gas pH <7.0 Did the baby have a cord blood gas pH <7.0? Within 24 hours of birth
Secondary Base excess What was the base excess on the cord blood gas? Within 24 hours of birth
Secondary Neonatal blood glucose What was the neonatal serum blood glucose at birth? Within 24 hours of birth
Secondary RDS Neonatal respiratory distress syndrome Within 30 days of delivery
Secondary TTN Transient tachypnea of the newborn Within 30 days of delivery
Secondary Hyperbilirubinemia Neonatal hyperbilirubinemia (as defined in AAP 2004 Clinical Practice Guideline "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation") Within 30 days of delivery
Secondary Neonatal sepsis Neonatal sepsis Within 30 days of delivery
Secondary NICU NICU admission Within 30 days of delivery
Secondary Length of stay (neonatal) How many days after birth did the neonate stay in the hospital? From birth until discharge (up to 1 year)
Secondary Congenital anomaly Congenital anomaly Within 30 days of delivery
Secondary IUFD or stillbirth Intrauterine fetal demise or stillbirth From conception until delivery
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