NCT02266758

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23,792

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

June 3, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

May 22, 2014

Last Update Submit

July 31, 2023

Conditions

Gestational DiabetesObesityPregnancy

Keywords

Gestational DiabetesObesityPregnancy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (9)

  • Birthweight

    Birth

  • Number of Pregnant Women with GDM Requiring Treatment

    During Pregnancy to Delivery, up to 10 months

  • Neonatal respiratory distress

    Birth to first year of life

  • Neonatal jaundice requiring treatment

    Birth to first year of life

  • Neonatal hypoglycemia

    Birth to first year of life

  • +4 more secondary outcomes

Other Outcomes (14)

  • Neonatal sepsis

    Birth up to 1 year

  • Neonatal intensive care unit (NICU) admission

    Birth up to 1 year

  • Preterm delivery (both <37 weeks and <32 weeks of gestation)

    Birth up to 1 year

  • +11 more other outcomes

Study Arms (2)

GDM Screening Method 1

OTHER

GDM Screening Methods

Other: GDM Screening Methods

GDM Screening Method 2

OTHER

GDM Screening Methods

Other: GDM Screening Methods

Interventions

GDM Screening MethodsOTHER
GDM Screening Method 1GDM Screening Method 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant adult women in KPNW and KPH

You may not qualify if:

  • pre-existing diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34384772DERIVED

  • 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.

    PMID: 33704936DERIVED

MeSH Terms

Conditions

Diabetes, GestationalObesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Teresa A Hillier, MD, MS

    KP Center for Health Resarch, NW & Hawaii

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

October 17, 2014

Study Start

June 3, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2024

Last Updated

August 2, 2023

Record last verified: 2023-07