Diabetes, Gestational, Diabetes Mellitus in Pregnancy, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERGlycemic 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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in birth weight | 41 weeks gestation | 250-gram difference in birth weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: targets met | 41 weeks gestation | Number of prenatal care visits in which patient met blood sugar targets |
| 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) |
| 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 |
| 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 |
| 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 |
| 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? |
| Intrapartum insulin | From onset of induction/labor until delivery | Did the patient need insulin during the intrapartum period? |
| Gestational weight gain | 41 weeks gestation | Total weight gain during pregnancy in kilograms |
| Antepartum admission | 41 weeks gestation | Was the patient ever admitted to antepartum service for any indication, including poorly-controlled diabetes or diabetes-related complication? |
| 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 |
| 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 |
| Gestational age at delivery | During intrapartum admission to Labor & Delivery | Gestational age at delivery |
| Induction of labor | During intrapartum admission to Labor & Delivery | Did the patient undergo induction of labor? |
| 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 |
| 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? |
| Blood loss | During intrapartum admission to Labor & Delivery | Quantitative blood loss (or estimated if quantitative is unknown) in cc's |
| 3rd or 4th degree laceration | During intrapartum admission to Labor & Delivery | 3rd or 4th degree perineal laceration |
| 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? |
| Chorioamnionitis | During intrapartum admission to Labor & Delivery | Chorioamnionitis |
| Endometritis | Within 30 days postpartum | Endometritis |
| VTE | From conception until 30 days postpartum | Venous thromboembolism: deep venous thrombosis or pulmonary embolism |
| Length of stay (maternal) | From admission to Labor & Delivery until discharge from postpartum | Length of hospital admission for labor, delivery, and postpartum |
| Postpartum readmission | Within 30 days postpartum | Did the patient get readmitted within 30 days of delivery? |
| Postpartum wound complication | Within 30 days postpartum | Cesarean wound infection of dehiscence, perineal laceration breakdown |
| Cardiac complications | From conception until 30 days postpartum | Did the patient develop any cardiac complications such as arrhythmias or cardiomyopathy? |
| 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 |
| LGA | Within 24 hours of birth | Large for gestational age (birth weight ≥90% for gestational age) |
| SGA | Within 24 hours of birth | Small for gestational age (birth weight \<10% for gestational age) |
| Shoulder dystocia | During intrapartum admission to Labor & Delivery | Shoulder dystocia |
| Apgar | 5 minutes after birth | 5-minute Apgar score |
| 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 |
| Total prenatal care visits | 41 weeks gestation | Total number of prenatal care visits during pregnancy |
| 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 |
| 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 |
| IUFD or stillbirth | From conception until delivery | Intrauterine fetal demise or stillbirth |
| TTN | Within 30 days of delivery | Transient tachypnea of the newborn |
Countries
United States
Contacts
Primary ContactBrendan H Grubbs, MD
Outcome results
None listed