Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Uno studio controllato randomizzato sullo screening del diabete immediatamente dopo il parto (DIP)

24 settembre 2026 aggiornato da: Kartik K Venkatesh, Ohio State University

Uno studio controllato randomizzato sullo screening del diabete immediatamente dopo il parto

DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.

Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

DIP: Individuals with gestational diabetes (GDM) during pregnancy have up to a 10-fold increased risk of developing of T2DM. Postpartum screening facilitates detection of impaired glucose tolerance and diabetes mellitus with the possibility for subsequent preventive and treatment interventions. The American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) recommend screening individuals with GDM postpartum with a 75-g, 2-hour oral glucose tolerance test (OGTT) that includes a fasting blood glu-cose.4,6 This is historically performed at 4-12 weeks so that it will coincide with the timing of the typical postpartum visit. However, the rate of postpartum screening with the recommended method are low, as many individuals do not seek timely postpartum care-only a quarter to one half of individuals undergo diabetes screening in the first year postpartum. Multiple structural barriers exist for patients and healthcare providers to effectively complete postpartum diabetes screening via the current recommended method. An immediate postpartum OGTT has been proposed as an alternative to the current standard practice which is generally performed between 4-12 week postpartum OGTT at the routine postpartum visit. An immediate OGTT has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum OGTT.

Follow up PP CARE: Postpartum adverse CVH is a critical public health problem and contributes to persistent and inequitable maternal health. Adverse cardiovascular health outcomes after delivery, including hypertension, dyslipidemia, diabetes, and obesity, are frequent and a major source of maternal morbidity and mortality. Ultimately, these conditions increase the risk of long-term cardiovascular disease which affects 60 million women in the United States (US). It represents the leading cause of death, contributing to 1 in 5 deaths in women in the US. Despite these epidemiologic associations, relatively less research exists on prevention, recognition and treatment of adverse CVH in high-risk postpartum women before the occurrence of clinical disease. Further, adverse CVH is more common among individuals who experience an adverse pregnancy outcome (APO), as well as adverse social determinants of health (SDOH), including self-identified minoritized race or ethnicity as a proxy for racism, low socioeconomic status, housing and food insecurity, and limited access to healthcare.

Tipo di studio

Interventistico

Iscrizione (Stimato)

104

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

DIP - Inclusion Criteria:

  • Immediately postpartum individuals during their delivery hospital admission

  • ≥ 18 years old with the ability to give informed consent.

  • Diagnosed with GDM during pregnancy by:

    • Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR
    • Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis

  • English or Spanish speaking

  • Receiving prenatal and postpartum care at OSU

DIP- Exclusion Criteria:

  • Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
  • Not English or Spanish speaking

PP CARE Inclusion criteria: Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.

PP CARE Exclusion criteria: Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Immediate inpatient postpartum OGTT

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Test diagnostico: Immediate inpatient postpartum OGTT

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Altro: Standard of care

Standard of care is 4-12 week outpatient postpartum OGTT
Test diagnostico: Standard of care 4-12 week postpartum OGTT

Standard of care is 4-12 week outpatient postpartum OGTT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of postpartum diabetes mellitus screening
Lasso di tempo: From delivery to up to 12 weeks postpartum

For patients randomized to inpatient immediate postpartum OGTT, completion of the inpatient test will be confirmed and documented by study staff prior to patient discharge. For patients randomized to the inpatient immediate postpartum OGTT who do not undergo inpatient testing and for patients randomized to the outpatient 4-12 week OGTT, individuals will receive an electronic survey via email at 12 weeks inquiring as to whether they underwent postpartum outpatient OGTT and about the results of testing, if performed.
From delivery to up to 12 weeks postpartum
Patient reported outcome of postpartum Cardiovascular health (CVH) counseling received within the first 12 months after delivery
Lasso di tempo: Within the first 12 months after delivery

Patient reported outcome of postpartum CVH counseling received within the first 12 months after delivery measured with modified questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 9 Core Mail Questionnaire and the clinical outcome of postpartum dysglycemia defined as a diagnosis of prediabetes or type 2 diabetes within the first 12 months after delivery.
Within the first 12 months after delivery
Patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.
Lasso di tempo: Between 12 and 24 months postpartum

Semi-structured virtual interviews will be performed including questions that encompass patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.
Between 12 and 24 months postpartum

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Risk perception and lifestyle modification
Lasso di tempo: From delivery to up to 12 weeks postpartum

"What do you think your risk or chance is for getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.")

"If you don't change your lifestyle behaviors, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.")

"Have you recently made changes in any lifestyle behaviors that you believe will lower your chance of getting diabetes?" (Responses: yes, no)

"Are you planning to make changes in any lifestyle behaviors in the near future that you believe will lower your chances of getting diabetes?" (Responses: yes, no)
From delivery to up to 12 weeks postpartum
Rates of primary care provider (PCP) visits within 1 year of delivery
Lasso di tempo: Within 1 year postpartum

All individuals will be sent an electronic survey via email inquiring as to whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner) and for what reason since the time of their delivery.
Within 1 year postpartum
Risk Perception Survey for Developing Diabetes
Lasso di tempo: From delivery to up to 12 weeks postpartum

The survey comprises 53 items and has four subscales and other individual items to address various dimensions of risk perception. Risk perception will be assessed as both continuous scales and as a dichotomous outcome ("no chance" and "slight chance" will be categorized as "low" risk perception, and "moderate chance" and "high chance" will be categorized as "high" risk perception.
From delivery to up to 12 weeks postpartum
Diabetes Treatment Satisfaction Questionnaire
Lasso di tempo: From delivery to up to 12 weeks postpartum

8 question survey will be scored as a continuous scale.
From delivery to up to 12 weeks postpartum
Prediabetes or type 2 diabetes
Lasso di tempo: Within 1 year postpartum

Prediabetes: OGTT between 140 to 199 mg/dl AND/OR A1c 5.7% to 6.4% AND/OR patient self-report Type 2 diabetes: OGTT 200 mg/dl or higher AND/OR A1c 6.5% or higher AND/OR patient self-report
Within 1 year postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ohio State University

Investigatori

  • Investigatore principale: Kartik K Venkatesh, MD, PhD, Ohio State University
  • Investigatore principale: Christine Field, MD, MPH, Ohio State University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 luglio 2023

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

9 giugno 2023

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2023

Primo Inserito (Effettivo)

18 giugno 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2023H0189

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi