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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD074794 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDM Screening Method 1 | Other | GDM Screening Methods |
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| GDM Screening Method 2 | Other | GDM Screening Methods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDM Screening Methods | Other |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa A Hillier, MD, MS | KP Center for Health Resarch, NW & Hawaii | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34384772 | Derived | 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. | |
| 33704936 | Derived | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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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 |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |