Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT

Conditions
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Gestational Diabetes, Obesity, Pregnancy

Intervention / Treatment
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* Other: GDM Screening Methods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant adult women in KPNW and KPH Exclusion Criteria: pre-existing diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GDM Screening Method 1<br>GDM Screening Methods | Other: GDM Screening Methods<br> <br> |
| Other: GDM Screening Method 2<br>GDM Screening Methods | Other: GDM Screening Methods<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pregnancies with GDM diagnosis | Diagnosis of GDM based on laboratory values for each screening approach (1-step or 2-step) as planned in the original protocol. | During Pregnancy to Delivery, up to 10 months | 
| Number of Newborns with Large for Gestational Age (LGA) Birthweight | Birthweight > 90th percentile | Birth | 
| Number of neonates with any component of a composite perinatal outcome | Includes any of the following: number of neonatal deaths, stillbirths, shoulder dystocia, bone fracture, or nerve palsy | Birth to first year of life | 
| Number of pregnant women with Gestational Hypertension & Pre-Eclampsia | Based on International Classification of Diseases (ICD-10) diagnoses | During Pregnancy to Delivery, up to 10 months | 
| Number of Cesarean Section Deliveries | Primary Cesarean Section | During Pregnancy to Delivery, up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight | Will evaluate macrosomia, large for gestational age (LGA), small for gestational age (SGA) and average birthweight. LGA remains a primary outcome. | Birth | 
| Number of Pregnant Women with GDM Requiring Treatment | Maternal GDM requiring insulin or oral hypoglycemic treatment (class A2GDM) | During Pregnancy to Delivery, up to 10 months | 
| Neonatal respiratory distress | Number of pregnancies for which newborn has a diagnosis of neonatal respiratory distress syndrome; planned in the original protocol. | Birth to first year of life | 
| Neonatal jaundice requiring treatment | Number of pregnancies for which newborn has a diagnosis of jaundice and received jaundice treatment; planned in the original protocol. | Birth to first year of life | 
| Neonatal hypoglycemia | Number of pregnancies for which newborn has a diagnosis of neonatal hypoglycemia; planned in the original protocol. | Birth to first year of life | 
| Number of stillbirths | Stillbirth is a secondary outcome; miscarriages were excluded | During Pregnancy to Delivery | 
| Number of Neonatal Deaths | Death of newborn under age 7 days | First week of life | 
| Number of Infants with Shoulder Dystocia | Diagnosed by ICD-10 | Birth to first year of life | 
| Number of Infant Bone Fractures or Nerve Palsies associated with delivery | Diagnosed by ICD-10 | Birth to first year of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes, Obesity, Pregnancy