Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO

Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Pregnancy; Gestational Diabetes
• Intervention / Treatment: Other: GDM Screening Methods

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.

• Study Type: Interventional
• Enrollment (Actual): 23792
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pregnant adult women in KPNW and KPH

Exclusion Criteria:

• pre-existing diabetes

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GDM Screening Method 1; GDM Screening Methods	Other: GDM Screening Methods
Other: GDM Screening Method 2; GDM Screening Methods	Other: GDM Screening Methods

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal sepsis	Safety outcome. Number of pregnancies for which newborn has a diagnosis of neonatal sepsis	Birth up to 1 year
Neonatal intensive care unit (NICU) admission	Safety outcome. Number of pregnancies for which newborn is admitted to the NICU	Birth up to 1 year
Preterm delivery (both <37 weeks and <32 weeks of gestation)	Safety outcome. Number of pregnancies in which delivery took place before 37 weeks of gestation; separately, number or pregnancies in which delivery took place before 32 weeks of gestation	Birth up to 1 year
Induction of labor	Safety outcome. Number of pregnancies in which labor was induced	During Pregnancy to Delivery, up to 10 months
Gestational Weight Gain	Weight Gain During Pregnancy	Pre-pregnancy, 1st trimester, 2nd trimester, 3rd trimester and overall to delivery, up to 10 months
Changes in pre-pregnancy to post-partum maternal weight	Maternal height and weight measurements to evaluate average weight retention post-partum compared to pre-pregnancy	pre-pregnancy up to 1 year post-partum
Number of Pregnancies with Multiple Maternal and Child GDM-Associated Outcomes	This pragmatic GDM screening RCT evaluates rates of multiple maternal and child GDM-associated outcomes with two standard-of-care screening strategies in a large population of pregnant women at two diverse HMO sites with routine universal screening for GDM. This first primary outcome encompasses the overarching goals of our pragmatic RCT, and other specific primary outcomes will be listed as subsequent primary outcome measures. This outcome was initially registered as an overall primary outcome and was intended (as stated in the study protocol) to include the number of pregnancies diagnosed with GDM based on laboratory values of the two screening approaches; the primary GDM diagnosis has been updated separately as a primary outcome as per protocol.	Beginning of Pregnancy up to 10 years post-partum
Number and Intensity of Utilization of Health Care Services	Quantification of health care visits, labs, procedures, and pharmacy for each pregnant woman	During Pregnancy to Delivery, up to 10 months
Changes in childhood height and weight measures	We will evaluate childhood growth percentiles and trajectories, as well as incidence of childhood overweight and obesity	Annually after birth up to 10 years
Number of mothers with post-partum diabetes	Development of post-partum diabetes by ICD-10 diagnoses and lab measurement	Annually after birth up to 10 years
Number of women with Post-partum depression	Based on maternal ICD-10 diagnoses and questionnaire assessment	Birth up to 1 year
Number of children with metabolic syndrome	Based on ICD-10 diagnoses and also measured components including blood pressure, lipid measurements, body mass index, and diabetes	Annually from birth up to 10 years
Number of Vaginal Assisted Deliveries	vaginal deliveries requiring assistance, including forceps and vacuum extraction	Delivery
Number of pregnant women with anxiety or depression	Based on ICD-10 diagnoses and questionnaire assessment	During Pregnancy to Delivery, up to 10 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Teresa A Hillier, MD, MS, KP Center for Health Resarch, NW & Hawaii

Publications and helpful links

General Publications

• Hillier TA, Pedula KL, Ogasawara KK, Vesco KK, Oshiro CES, Lubarsky SL, Van Marter J. Further implications from a pragmatic randomized clinical trial of gestational diabetes screening: per-protocol and as-treated estimates. Am J Obstet Gynecol. 2021 Nov;225(5):581-583. doi: 10.1016/j.ajog.2021.08.006. Epub 2021 Aug 9.
• Hillier TA, Pedula KL, Ogasawara KK, Vesco KK, Oshiro CES, Lubarsky SL, Van Marter J. A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening. N Engl J Med. 2021 Mar 11;384(10):895-904. doi: 10.1056/NEJMoa2026028.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimated): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Gestational Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: R01HD074794 (U.S. NIH Grant/Contract)