Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO
- Conditions
- PregnancyObesityGestational Diabetes
- Interventions
- Other: GDM Screening Methods
- Registration Number
- NCT02266758
- Lead Sponsor
- Kaiser Permanente
- Brief Summary
This project randomizes two different screening strategies for diabetes in pregnancy, among a study population of over 17,500 pregnant women and their babies (over 35,000 total) in a large diverse health maintenance organization (HMO), to determine how diagnosis and treatment based on these two strategies in routine clinical care affects complications for the baby and the mother.
- Detailed Description
Two recent randomized placebo-controlled trials show that gestational diabetes (GDM) treatment (vs. none) improves maternal and perinatal outcomes, based on diagnosis with a 2- step screening strategy. Also, a large multi-center prospective cohort study showed a linear relationship with glucose and maternal and perinatal outcomes, based on screening with a single 75g oral glucose tolerance test (OGTT). Based on this large cohort's findings, the American Diabetes Association recommended that clinical practice adopt the 1-step 75g screening approach for diagnosing GDM. The American College of Obstetrics \& Gynecology took the opposite stance, recommending the traditional 2-step screening: because it alone has RCT outcome evidence. What is urgently needed to best inform clinical practice and health policy is not an additional GDM treatment vs. control trial, but a pragmatic randomized controlled trial (RCT) testing the 2 recommended clinical strategies. To pragmatically address this critical research gap, we propose to randomize an estimated 17,626 diverse women to GDM screening (2-step vs. 75g OGTT) as part of their clinical care in the Kaiser Permanente Northwest (KPNW) and Hawaii (KPH) regional health plans. The investigators will use the plans' electronic medical record (EMR) system at the time of GDM screening to randomize the women. Both KPNW and KPH regions universally screen for GDM at 24-28 weeks gestation, as part of clinical care. By randomizing GDM screening in the context of clinical care, the investigators will: Compare GDM prevalences (Aim 1) and differences in maternal and perinatal outcomes between screening strategies (Aim 2). Determine the concordance of the 75g OGTT with GDM diagnosed by 2-step, among a recruited sub-sample of 1,000 pregnant women at KPNW and KPH (Aim 3). The results of this pragmatic RCT are expected to help resolve the current public policy debate on the potential benefits and risks of each strategy in clinical obstetric practice.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 23792
- pregnant adult women in KPNW and KPH
- pre-existing diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GDM Screening Method 2 GDM Screening Methods GDM Screening Methods GDM Screening Method 1 GDM Screening Methods GDM Screening Methods
- Primary Outcome Measures
Name Time Method Number of Newborns with Large for Gestational Age (LGA) Birthweight Birth Birthweight \> 90th percentile
Number of pregnant women with Gestational Hypertension & Pre-Eclampsia During Pregnancy to Delivery, up to 10 months Based on International Classification of Diseases (ICD-10) diagnoses
Number of Pregnancies with GDM diagnosis During Pregnancy to Delivery, up to 10 months Diagnosis of GDM based on laboratory values for each screening approach (1-step or 2-step) as planned in the original protocol.
Number of Cesarean Section Deliveries During Pregnancy to Delivery, up to 10 months Primary Cesarean Section
Number of neonates with any component of a composite perinatal outcome Birth to first year of life Includes any of the following: number of neonatal deaths, stillbirths, shoulder dystocia, bone fracture, or nerve palsy
- Secondary Outcome Measures
Name Time Method Number of Neonatal Deaths First week of life Death of newborn under age 7 days
Number of Infants with Shoulder Dystocia Birth to first year of life Diagnosed by ICD-10
Number of stillbirths During Pregnancy to Delivery Stillbirth is a secondary outcome; miscarriages were excluded
Number of Pregnant Women with GDM Requiring Treatment During Pregnancy to Delivery, up to 10 months Maternal GDM requiring insulin or oral hypoglycemic treatment (class A2GDM)
Neonatal respiratory distress Birth to first year of life Number of pregnancies for which newborn has a diagnosis of neonatal respiratory distress syndrome; planned in the original protocol.
Neonatal jaundice requiring treatment Birth to first year of life Number of pregnancies for which newborn has a diagnosis of jaundice and received jaundice treatment; planned in the original protocol.
Neonatal hypoglycemia Birth to first year of life Number of pregnancies for which newborn has a diagnosis of neonatal hypoglycemia; planned in the original protocol.
Birthweight Birth Will evaluate macrosomia, large for gestational age (LGA), small for gestational age (SGA) and average birthweight. LGA remains a primary outcome.
Number of Infant Bone Fractures or Nerve Palsies associated with delivery Birth to first year of life Diagnosed by ICD-10