Clinical trial NCT02266758: Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO
Official title: Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Obesity
Pregnancy
Keywords: Gestational Diabetes
Obesity
Pregnancy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-10-17
Enrollment: 23792
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* pregnant adult women in KPNW and KPH

Exclusion Criteria:

* pre-existing diabetes

Primary outcomes:
measure: Number of Pregnancies with GDM diagnosis
timeFrame: During Pregnancy to Delivery, up to 10 months
measure: Number of Newborns with Large for Gestational Age (LGA) Birthweight
timeFrame: Birth
measure: Number of neonates with any component of a composite perinatal outcome
timeFrame: Birth to first year of life
measure: Number of pregnant women with Gestational Hypertension & Pre-Eclampsia
timeFrame: During Pregnancy to Delivery, up to 10 months
measure: Number of Cesarean Section Deliveries
timeFrame: During Pregnancy to Delivery, up to 10 months
Secondary outcomes:
measure: Birthweight
timeFrame: Birth
measure: Number of Pregnant Women with GDM Requiring Treatment
timeFrame: During Pregnancy to Delivery, up to 10 months
measure: Neonatal respiratory distress
timeFrame: Birth to first year of life
measure: Neonatal jaundice requiring treatment
timeFrame: Birth to first year of life
measure: Neonatal hypoglycemia
timeFrame: Birth to first year of life
measure: Number of stillbirths
timeFrame: During Pregnancy to Delivery
measure: Number of Neonatal Deaths
timeFrame: First week of life
measure: Number of Infants with Shoulder Dystocia
timeFrame: Birth to first year of life
measure: Number of Infant Bone Fractures or Nerve Palsies associated with delivery
timeFrame: Birth to first year of life
Other outcomes:
measure: Neonatal sepsis
timeFrame: Birth up to 1 year
measure: Neonatal intensive care unit (NICU) admission
timeFrame: Birth up to 1 year
measure: Preterm delivery (both <37 weeks and <32 weeks of gestation)
timeFrame: Birth up to 1 year
measure: Induction of labor
timeFrame: During Pregnancy to Delivery, up to 10 months
measure: Gestational Weight Gain
timeFrame: Pre-pregnancy, 1st trimester, 2nd trimester, 3rd trimester and overall to delivery, up to 10 months
measure: Changes in pre-pregnancy to post-partum maternal weight
timeFrame: pre-pregnancy up to 1 year post-partum
measure: Number of Pregnancies with Multiple Maternal and Child GDM-Associated Outcomes
timeFrame: Beginning of Pregnancy up to 10 years post-partum
measure: Number and Intensity of Utilization of Health Care Services
timeFrame: During Pregnancy to Delivery, up to 10 months
measure: Changes in childhood height and weight measures
timeFrame: Annually after birth up to 10 years
measure: Number of mothers with post-partum diabetes
timeFrame: Annually after birth up to 10 years
measure: Number of women with Post-partum depression
timeFrame: Birth up to 1 year
measure: Number of children with metabolic syndrome
timeFrame: Annually from birth up to 10 years
measure: Number of Vaginal Assisted Deliveries
timeFrame: Delivery
measure: Number of pregnant women with anxiety or depression
timeFrame: During Pregnancy to Delivery, up to 10 months
Locations:
Study officials:
affiliation: KP Center for Health Resarch, NW & Hawaii
name: Teresa A Hillier, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.