Glycemic Targets for Pregnant Women With GDM and T2DM
- Conditions
- Diabetes Mellitus, Type 2Diabetes, GestationalDiabetes Mellitus in Pregnancy
- Interventions
- Other: Glycemic Targets
- Registration Number
- NCT04672031
- Lead Sponsor
- University of Southern California
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- Pregnant women with a singleton gestation
- 18 years or older
- Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes
- Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
- Type 1 diabetes
- Diabetic retinopathy
- Diabetic nephropathy
- Diabetic vasculopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Arm Glycemic Targets 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.
- Primary Outcome Measures
Name Time Method Difference in birth weight 41 weeks gestation 250-gram difference in birth weight
- Secondary Outcome Measures
Name Time Method Total prenatal care visits 41 weeks gestation Total number of prenatal care visits during pregnancy
Gestational weight gain 41 weeks gestation Total weight gain during pregnancy in kilograms
Prenatal care visits after enrollment 41 weeks gestation Number of prenatal care visits after enrollment
Prenatal care visits: log/glucometer 41 weeks gestation Number of prenatal care visits with log/glucometer available for RN or MD to review
Prenatal care visits: intervention 41 weeks gestation Number of prenatal care visits in which an intervention for blood sugars was recommended (e.g. starting medication or changing medication dose)
Prenatal care visits: targets met 41 weeks gestation Number of prenatal care visits in which patient met blood sugar targets
Symptomatic hypoglycemia 41 weeks gestation Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as \<70 mg/dL per ADA)
Asymptomatic hypoglycemia 41 weeks gestation Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as \<70 mg/dL per ADA)
A1c enrollment At time of enrollment (up to 34 weeks gestation) Hemoglobin A1c at the time of enrollment
A1c 36 weeks At 36 weeks gestational age Hemoglobin A1c at 36 weeks gestational age
Gestational age at delivery During intrapartum admission to Labor & Delivery Gestational age at delivery
Lowest recorded blood sugar 41 weeks gestation Lowest recorded blood sugar during prenatal care
Highest recorded blood sugar 41 weeks gestation Highest recorded blood sugar during prenatal care
Intrapartum insulin From onset of induction/labor until delivery Did the patient need insulin during the intrapartum period?
Average recorded blood sugar 41 weeks gestation Average recorded blood sugar during prenatal care
Weekly compliance 41 weeks gestation Average number of blood sugar checks actually performed each week
Induction of labor During intrapartum admission to Labor & Delivery Did the patient undergo induction of labor?
Weekly target assessment 41 weeks gestation % of blood sugars within goal each week
Diabetes medication 41 weeks gestation Did the patient need diabetes medication (including oral agents and insulin) during antepartum period?
Corticosteroids 41 weeks gestation Did the patient receive antenatal corticosteroid treatment?
Oligohydramnios 41 weeks gestation Amniotic fluid index \<5 cm or maximum vertical pocket \<2cm
Antepartum admission 41 weeks gestation Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication?
Polyhydramnios 41 weeks gestation Amniotic fluid index \>24cm or maximum vertical pocket \>8cm
Fetal growth restriction 41 weeks gestation Ultrasonographic estimated fetal weight or abdominal circumference \<10% for gestational ag
Cesarean indication During intrapartum admission to Labor & Delivery If the patient had cesarean delivery, what was the indication?
TOLAC During intrapartum admission to Labor & Delivery Did the patient attempt a trial of labor after cesarean?
Endometritis Within 30 days postpartum Endometritis
VTE From conception until 30 days postpartum Venous thromboembolism: deep venous thrombosis or pulmonary embolism
Postpartum readmission Within 30 days postpartum Did the patient get readmitted within 30 days of delivery?
3rd or 4th degree laceration During intrapartum admission to Labor & Delivery 3rd or 4th degree perineal laceration
Length of stay (maternal) From admission to Labor & Delivery until discharge from postpartum Length of hospital admission for labor, delivery, and postpartum
Cardiac complications From conception until 30 days postpartum Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy?
Mode of delivery During intrapartum admission to Labor & Delivery primary cesarean section, repeat cesarean section, vaginal delivery, vaginal delivery with vacuum, vaginal delivery with forceps
Blood loss During intrapartum admission to Labor & Delivery Quantitative blood loss (or estimated if quantitative is unknown) in cc's
PIH From 20 weeks gestation until 30 days postpartum Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome)
Hypertensive emergency From conception until 30 days postpartum Did the patient have severe-range blood pressures require antihypertensive medication?
Postpartum wound complication Within 30 days postpartum Cesarean wound infection of dehiscence, perineal laceration breakdown
Chorioamnionitis During intrapartum admission to Labor & Delivery Chorioamnionitis
Seizures From conception until 30 days postpartum Did any maternal seizures occur during the pregnancy or postpartum?
Macrosomia Within 24 hours of birth Birth weight \>4000 grams
SGA Within 24 hours of birth Small for gestational age (birth weight \<10% for gestational age)
Apgar 5 minutes after birth 5-minute Apgar score
LGA Within 24 hours of birth Large for gestational age (birth weight ≥90% for gestational age)
Shoulder dystocia During intrapartum admission to Labor & Delivery Shoulder dystocia
Cord gas pH <7.0 Within 24 hours of birth Did the baby have a cord blood gas pH \<7.0?
Base excess Within 24 hours of birth What was the base excess on the cord blood gas?
Neonatal blood glucose Within 24 hours of birth What was the neonatal serum blood glucose at birth?
RDS Within 30 days of delivery Neonatal respiratory distress syndrome
TTN Within 30 days of delivery Transient tachypnea of the newborn
Hyperbilirubinemia Within 30 days of delivery Neonatal hyperbilirubinemia (as defined in AAP 2004 Clinical Practice Guideline "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation")
Neonatal sepsis Within 30 days of delivery Neonatal sepsis
IUFD or stillbirth From conception until delivery Intrauterine fetal demise or stillbirth
NICU Within 30 days of delivery NICU admission
Length of stay (neonatal) From birth until discharge (up to 1 year) How many days after birth did the neonate stay in the hospital?
Congenital anomaly Within 30 days of delivery Congenital anomaly
Trial Locations
- Locations (1)
Los Angeles County + University of Southern California Medical Center (LAC+USC)
🇺🇸Los Angeles, California, United States