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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Los Angeles County + University of Southern California Medical Center (LAC+USC)
Los Angeles, California, United States
RECRUITINGDifference in birth weight
250-gram difference in birth weight
Time frame: 41 weeks gestation
Total prenatal care visits
Total number of prenatal care visits during pregnancy
Time frame: 41 weeks gestation
Prenatal care visits after enrollment
Number of prenatal care visits after enrollment
Time frame: 41 weeks gestation
Prenatal care visits: log/glucometer
Number of prenatal care visits with log/glucometer available for RN or MD to review
Time frame: 41 weeks gestation
Prenatal care visits: targets met
Number of prenatal care visits in which patient met blood sugar targets
Time frame: 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)
Time frame: 41 weeks gestation
Symptomatic hypoglycemia
Frequency of symptomatic hypoglycemia episodes (hypoglycemia defined as \<70 mg/dL per ADA)
Time frame: 41 weeks gestation
Asymptomatic hypoglycemia
Frequency of asymptomatic hypoglycemia episodes (hypoglycemia defined as \<70 mg/dL per ADA)
Time frame: 41 weeks gestation
A1c enrollment
Hemoglobin A1c at the time of enrollment
Time frame: At time of enrollment (up to 34 weeks gestation)
A1c 36 weeks
Hemoglobin A1c at 36 weeks gestational age
Time frame: At 36 weeks gestational age
Lowest recorded blood sugar
Lowest recorded blood sugar during prenatal care
Time frame: 41 weeks gestation
Highest recorded blood sugar
Highest recorded blood sugar during prenatal care
Time frame: 41 weeks gestation
Average recorded blood sugar
Average recorded blood sugar during prenatal care
Time frame: 41 weeks gestation
Weekly compliance
Average number of blood sugar checks actually performed each week
Time frame: 41 weeks gestation
Weekly target assessment
% of blood sugars within goal each week
Time frame: 41 weeks gestation
Diabetes medication
Did the patient need diabetes medication (including oral agents and insulin) during antepartum period?
Time frame: 41 weeks gestation
Intrapartum insulin
Did the patient need insulin during the intrapartum period?
Time frame: From onset of induction/labor until delivery
Gestational weight gain
Total weight gain during pregnancy in kilograms
Time frame: 41 weeks gestation
Antepartum admission
Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication?
Time frame: 41 weeks gestation
Corticosteroids
Did the patient receive antenatal corticosteroid treatment?
Time frame: 41 weeks gestation
Oligohydramnios
Amniotic fluid index \<5 cm or maximum vertical pocket \<2cm
Time frame: 41 weeks gestation
Polyhydramnios
Amniotic fluid index \>24cm or maximum vertical pocket \>8cm
Time frame: 41 weeks gestation
Fetal growth restriction
Ultrasonographic estimated fetal weight or abdominal circumference \<10% for gestational ag
Time frame: 41 weeks gestation
Gestational age at delivery
Gestational age at delivery
Time frame: During intrapartum admission to Labor & Delivery
Induction of labor
Did the patient undergo induction of labor?
Time frame: 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
Time frame: During intrapartum admission to Labor & Delivery
Cesarean indication
If the patient had cesarean delivery, what was the indication?
Time frame: During intrapartum admission to Labor & Delivery
TOLAC
Did the patient attempt a trial of labor after cesarean?
Time frame: During intrapartum admission to Labor & Delivery
Blood loss
Quantitative blood loss (or estimated if quantitative is unknown) in cc's
Time frame: During intrapartum admission to Labor & Delivery
3rd or 4th degree laceration
3rd or 4th degree perineal laceration
Time frame: During intrapartum admission to Labor & Delivery
PIH
Pregnancy-induced hypertension (gestational hypertension, preeclampsia, HELLP syndrome)
Time frame: From 20 weeks gestation until 30 days postpartum
Hypertensive emergency
Did the patient have severe-range blood pressures require antihypertensive medication?
Time frame: From conception until 30 days postpartum
Chorioamnionitis
Chorioamnionitis
Time frame: During intrapartum admission to Labor & Delivery
Endometritis
Endometritis
Time frame: Within 30 days postpartum
VTE
Venous thromboembolism: deep venous thrombosis or pulmonary embolism
Time frame: From conception until 30 days postpartum
Length of stay (maternal)
Length of hospital admission for labor, delivery, and postpartum
Time frame: From admission to Labor & Delivery until discharge from postpartum
Postpartum readmission
Did the patient get readmitted within 30 days of delivery?
Time frame: Within 30 days postpartum
Postpartum wound complication
Cesarean wound infection of dehiscence, perineal laceration breakdown
Time frame: Within 30 days postpartum
Cardiac complications
Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy?
Time frame: From conception until 30 days postpartum
Seizures
Did any maternal seizures occur during the pregnancy or postpartum?
Time frame: From conception until 30 days postpartum
Macrosomia
Birth weight \>4000 grams
Time frame: Within 24 hours of birth
LGA
Large for gestational age (birth weight ≥90% for gestational age)
Time frame: Within 24 hours of birth
SGA
Small for gestational age (birth weight \<10% for gestational age)
Time frame: Within 24 hours of birth
Shoulder dystocia
Shoulder dystocia
Time frame: During intrapartum admission to Labor & Delivery
Apgar
5-minute Apgar score
Time frame: 5 minutes after birth
Cord gas pH <7.0
Did the baby have a cord blood gas pH \<7.0?
Time frame: Within 24 hours of birth
Base excess
What was the base excess on the cord blood gas?
Time frame: Within 24 hours of birth
Neonatal blood glucose
What was the neonatal serum blood glucose at birth?
Time frame: Within 24 hours of birth
RDS
Neonatal respiratory distress syndrome
Time frame: Within 30 days of delivery
TTN
Transient tachypnea of the newborn
Time frame: 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")
Time frame: Within 30 days of delivery
Neonatal sepsis
Neonatal sepsis
Time frame: Within 30 days of delivery
NICU
NICU admission
Time frame: Within 30 days of delivery
Length of stay (neonatal)
How many days after birth did the neonate stay in the hospital?
Time frame: From birth until discharge (up to 1 year)
Congenital anomaly
Congenital anomaly
Time frame: Within 30 days of delivery
IUFD or stillbirth
Intrauterine fetal demise or stillbirth
Time frame: From conception until delivery
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