Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
- Registration Number
- NCT06419777
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
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 threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
- Detailed Description
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 gestational diabetes. Our goal is to compare a strict and relaxed threshold. The strict threshold is defined as two abnormal values or more over a one week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the relaxed threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 430
- Live, non-anomalous fetus
- Literacy in English, Spanish, Mandarin, or Arabic
- Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
- <18 years at EDD
- pre-existing diabetes or diagnosis of GDM before 24 weeks
- multi-fetal gestation
- known major fetal anomaly
- known allergy to insulin
- chronic maternal corticosteroid use
- diagnosis of GDM based on finger sticks alone
- patients who have contraindication to oral glucose tolerance test
- a primary language other than English, Spanish, Mandarin, or Arabic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Permissive Insulin The permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values). Strict Arm Insulin The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated)
- Primary Outcome Measures
Name Time Method Neonatal Composite Outcome First 28 days of birth 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
- Secondary Outcome Measures
Name Time Method Neonatal Outcome: Gestational Age of Birth Delivery Time Gestational age at delivery in weeks and days
Maternal Outcomes: Postpartum hemorrhage Within 24 hours of delivery Defined as cumulative blood loss ≥1000 mL, or bleeding associated with signs/symptoms of hypovolemia within 24 hours of the birth process
Neonatal Outcome: Birthweight Delivery Time Birthweight in grams, Macrosomia (birthweight \>4000g, Small for gestational age (\<10th percentile based on Fenton Growth Charts)
Maternal Outcomes: Maternal hypoglycemia Initiation of insulin to delivery Maternal episode of hypoglycemia \< 60 mg/dL throughout the pregnancy
Maternal Outcomes: Shoulder Dystocia At Delivery An obstetric emergency where the anterior fetal shoulder becomes stuck on the maternal pubic symphysis, delaying the birth of the baby's body.
Neonatal Outcome: APGAR Score At 1 minute of life and at 5 min of life Scoring system provided a standardized assessment for infants after delivery from 0-10
Maternal Outcomes: Obstetric anal sphincter injury (OASIS) At Delivery 3rd degree and 4th degree perineal injuries
Maternal Outcomes: Operative Delivery At Delivery Vacuum-assisted and Forcep-assisted vaginal Delivery
Neonatal Outcome: Brachial Plexus Injury Delivery Time Brachial plexus nerves in neonate are torn, stretched, or compressed at delivery
Neonatal Outcome: Respiratory distress Within first 24 hours after delivery Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant
Neonatal Outcome: Admission to Neonatal intensive Care Unit From delivery to discharge from NICU Admission to neonatal intensive care unit (NICU)
Maternal Outcomes: Cesarean Delivery At Delivery Cesarean birth
Maternal Outcomes: Hypertensive Disorders of Pregnancy From gestational age of 20 weeks during pregnancy to 6 weeks postpartum 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
Trial Locations
- Locations (2)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States