Gestational DiabetesNCT02266758
Randomizing Two Gestational Diabetes Screening Methods in a Diverse HMO
A study testing GDM Screening Methods in people with Gestational Diabetes and Obesity, run by Kaiser Permanente.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Obesity, Pregnancy
- What is being tested?
- GDM Screening Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,792 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2014to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant adult women in KPNW and KPH
Who cannot join
- pre-existing diabetes
About this study
Official title: 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.
Read the 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
- Being tested
- GDM Screening Methods
- Keywords
- Gestational Diabetes, Obesity, Pregnancy
- Medical subject headings
- Diabetes, Gestational, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDM Screening MethodsOther
| Study group | Role | What they receive |
|---|---|---|
| GDM Screening Method 1 | Other | GDM Screening Methods Receives: Other: GDM Screening Methods |
| GDM Screening Method 2 | Other | GDM Screening Methods Receives: Other: GDM Screening Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Pregnancy to Delivery, up to 10 months
Number of Newborns with Large for Gestational Age (LGA) Birthweight
Birthweight > 90th percentile
Measured: 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
Measured: Birth to first year of life
Number of pregnant women with Gestational Hypertension & Pre-Eclampsia
Based on International Classification of Diseases (ICD-10) diagnoses
Measured: During Pregnancy to Delivery, up to 10 months
Number of Cesarean Section Deliveries
Primary Cesarean Section
Measured: During Pregnancy to Delivery, up to 10 months
Secondary outcomes (9)
Birthweight
Will evaluate macrosomia, large for gestational age (LGA), small for gestational age (SGA) and average birthweight. LGA remains a primary outcome.
Measured: Birth
Number of Pregnant Women with GDM Requiring Treatment
Maternal GDM requiring insulin or oral hypoglycemic treatment (class A2GDM)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Birth to first year of life
Number of stillbirths
Stillbirth is a secondary outcome; miscarriages were excluded
Measured: During Pregnancy to Delivery
Number of Neonatal Deaths
Death of newborn under age 7 days
Measured: First week of life
Number of Infants with Shoulder Dystocia
Diagnosed by ICD-10
Measured: Birth to first year of life
Number of Infant Bone Fractures or Nerve Palsies associated with delivery
Diagnosed by ICD-10
Measured: Birth to first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start3 Jun 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23,792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Teresa A Hillier, MD, MS, Principal investigator, KP Center for Health Resarch, NW & Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266758
- Sponsor's protocol ID
- R01HD074794
- Other IDs
- R01HD074794
- Status last verified
- Jul 2023
- First submitted
- 22 May 2014
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34384772Hillier 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.
PubMed 33704936
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT
- ClinicalTrials.gov ID
- NCT02266758
- Acronym / sponsor ID
- R01HD074794
- Conditions
- Gestational Diabetes, Obesity, Pregnancy
- Keywords
- Gestational Diabetes, Obesity, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23,792 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM Screening Method 1 | Other | Other: GDM Screening MethodsGDM Screening Methods |
| GDM Screening Method 2 | Other | Other: GDM Screening MethodsGDM Screening Methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant adult women in KPNW and KPH
Key exclusion criteria (1 listed)
- pre-existing diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDM Screening Methods | Other | GDM Screening Method 1, GDM Screening Method 2 |
Primary outcome
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.
Number of Newborns with Large for Gestational Age (LGA) Birthweight
Time frame: Birth
Birthweight > 90th percentile
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
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
Number of Cesarean Section Deliveries
Time frame: During Pregnancy to Delivery, up to 10 months
Primary Cesarean Section
9 secondary outcomes
Birthweight
Time frame: Birth
Number of Pregnant Women with GDM Requiring Treatment
Time frame: During Pregnancy to Delivery, up to 10 months
Neonatal respiratory distress
Time frame: Birth to first year of life
Neonatal jaundice requiring treatment
Time frame: Birth to first year of life
Neonatal hypoglycemia
Time frame: Birth to first year of life
Number of stillbirths
Time frame: During Pregnancy to Delivery
Number of Neonatal Deaths
Time frame: First week of life
Number of Infants with Shoulder Dystocia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 34384772Hillier 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.
- Derived from this study: PubMed 33704936Hillier 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa A Hillier, MD, MS principal investigator
KP Center for Health Resarch, NW & Hawaii
Questions about this trial
What is this clinical trial studying?
A study testing GDM Screening Methods in people with Gestational Diabetes and Obesity, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Pregnancies with GDM diagnosis (time frame: During Pregnancy to Delivery, up to 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02266758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.