The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.
Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance. Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds. The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for GDM using continuous glucose monitor. Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
Insulin will be used in gestational diabetics to control blood glucose levels
University of Rochester Medical Center
Rochester, New York, United States
NOT_YET_RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGNeonatal Composite Outcome
Neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma
Time frame: First 28 days of birth
Neonatal Outcome: Gestational Age of Birth
Gestational age at delivery in weeks and days
Time frame: Delivery Time
Neonatal Outcome: APGAR Score
Scoring system provided a standardized assessment for infants after delivery from 0-10
Time frame: At 1 minute of life and at 5 min of life
Neonatal Outcome: Birthweight
Birthweight in grams, Macrosomia (birthweight \>4000g, Small for gestational age (\<10th percentile based on Fenton Growth Charts)
Time frame: Delivery Time
Neonatal Outcome: Respiratory distress
Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant
Time frame: Within first 24 hours after delivery
Neonatal Outcome: Admission to Neonatal intensive Care Unit
Admission to neonatal intensive care unit (NICU)
Time frame: From delivery to discharge from NICU
Maternal Outcomes: Maternal hypoglycemia
Maternal episode of hypoglycemia \< 60 mg/dL throughout the pregnancy
Time frame: Initiation of insulin to delivery
Maternal Outcomes: Shoulder Dystocia
An obstetric emergency where the anterior fetal shoulder becomes stuck on the maternal pubic symphysis, delaying the birth of the baby's body
Time frame: At Delivery
Maternal Outcomes: Obstetric anal sphincter injury (OASIS)
3rd degree and 4th degree perineal injuries
Time frame: At Delivery
Maternal Outcomes: Operative Delivery
Vacuum-assisted and Forcep-assisted vaginal Delivery
Time frame: At Delivery
Maternal Outcomes: Cesarean Delivery
Cesarean birth
Time frame: At Delivery
Maternal Outcomes: Postpartum hemorrhage
Defined as cumulative blood loss ≥1000 mL, or bleeding associated with signs/symptoms of hypovolemia within 24 hours of the birth process
Time frame: Within 24 hours of delivery
Maternal Outcomes: Hypertensive Disorders of Pregnancy
Hypertensive disorders of pregnancy: gestational hypertension, Preeclampsia without severe features, Pre-eclampsia with severe features, severe range blood pressures defined as (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg), symptoms of central nervous dysfunction, thrombocytopenia with Platelet count \<100,000 platelets/microL, hepatic abnormalities, kidney impairment, and or pulmonary edema
Time frame: From gestational age of 20 weeks during pregnancy to 6 weeks postpartum
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