Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO

July 31, 2023 updated by: Kaiser Permanente

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23792

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Pregnancies with GDM diagnosis
Time Frame: 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.
During Pregnancy to Delivery, up to 10 months
Number of Newborns with Large for Gestational Age (LGA) Birthweight
Time Frame: Birth
Birthweight > 90th percentile
Birth
Number of neonates with any component of a composite perinatal outcome
Time Frame: Birth to first year of life
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
Time Frame: During Pregnancy to Delivery, up to 10 months
Based on International Classification of Diseases (ICD-10) diagnoses
During Pregnancy to Delivery, up to 10 months
Number of Cesarean Section Deliveries
Time Frame: During Pregnancy to Delivery, up to 10 months
Primary Cesarean Section
During Pregnancy to Delivery, up to 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Birthweight
Time Frame: Birth
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
Time Frame: During Pregnancy to Delivery, up to 10 months
Maternal GDM requiring insulin or oral hypoglycemic treatment (class A2GDM)
During Pregnancy to Delivery, up to 10 months
Neonatal respiratory distress
Time Frame: 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.
Birth to first year of life
Neonatal jaundice requiring treatment
Time Frame: 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.
Birth to first year of life
Neonatal hypoglycemia
Time Frame: Birth to first year of life
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
Time Frame: During Pregnancy to Delivery
Stillbirth is a secondary outcome; miscarriages were excluded
During Pregnancy to Delivery
Number of Neonatal Deaths
Time Frame: First week of life
Death of newborn under age 7 days
First week of life
Number of Infants with Shoulder Dystocia
Time Frame: Birth to first year of life
Diagnosed by ICD-10
Birth to first year of life
Number of Infant Bone Fractures or Nerve Palsies associated with delivery
Time Frame: Birth to first year of life
Diagnosed by ICD-10
Birth to first year of life

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neonatal sepsis
Time Frame: Birth up to 1 year
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
Time Frame: Birth up to 1 year
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)
Time Frame: Birth up to 1 year
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
Time Frame: During Pregnancy to Delivery, up to 10 months
Safety outcome. Number of pregnancies in which labor was induced
During Pregnancy to Delivery, up to 10 months
Gestational Weight Gain
Time Frame: Pre-pregnancy, 1st trimester, 2nd trimester, 3rd trimester and overall to delivery, up to 10 months
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
Time Frame: pre-pregnancy up to 1 year post-partum
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
Time Frame: Beginning of Pregnancy up to 10 years post-partum
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
Time Frame: During Pregnancy to Delivery, up to 10 months
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
Time Frame: Annually after birth up to 10 years
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
Time Frame: Annually after birth up to 10 years
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
Time Frame: Birth up to 1 year
Based on maternal ICD-10 diagnoses and questionnaire assessment
Birth up to 1 year
Number of children with metabolic syndrome
Time Frame: Annually from birth up to 10 years
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
Time Frame: Delivery
vaginal deliveries requiring assistance, including forceps and vacuum extraction
Delivery
Number of pregnant women with anxiety or depression
Time Frame: During Pregnancy to Delivery, up to 10 months
Based on ICD-10 diagnoses and questionnaire assessment
During Pregnancy to Delivery, up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa A Hillier, MD, MS, KP Center for Health Resarch, NW & Hawaii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HD074794 (U.S. NIH Grant/Contract)

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