Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO

NCT ID: NCT02266758

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 23792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-03
• Study Completion Date: 2024-12-31

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.

Conditions

Gestational Diabetes; Obesity; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

GDM Screening Method 1

GDM Screening Methods

Group Type: OTHER

GDM Screening Methods

Intervention Type: OTHER

GDM Screening Method 2

GDM Screening Methods

Group Type: OTHER

GDM Screening Methods

Intervention Type: OTHER

Interventions

GDM Screening Methods

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• pregnant adult women in KPNW and KPH

Exclusion Criteria

• pre-existing diabetes

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa A Hillier, MD, MS

Role: PRINCIPAL_INVESTIGATOR

KP Center for Health Resarch, NW & Hawaii

References

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.

Reference Type: DERIVED

PMID: 34384772 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33704936 (View on PubMed)

Other Identifiers

R01HD074794

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD074794

Identifier Type: NIH

Identifier Source: org_study_id

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