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ULTRASOUND ASSESSMENT OF GASTRİC VOLUME IN PREGNANT WOMEN UNDERGOİNG ELECTİVE CESAREAN SECTİON, WITH AND WITHOUT GESTATİONAL DIABETES MELLITUS (GDM)

8 de setembro de 2026 atualizado por: Mehmet Tunç, Gaziantep City Hospital

THE PRIMARY OBJECTIVE OF THIS STUDY IS TO COMPARE GASTRIC VOLUME PRIOR TO ELECTIVE CESAREAN SECTION BETWEEN PREGNANT WOMEN DIAGNOSED WITH GESTATIONAL DIABETES MELLITUS (GDM) AND THOSE WITHOUT GDM.

THE SECONDARY OBJECTIVES ARE TO EVALUATE THE EFFECT OF GDM ON PREOPERATIVE RESIDUAL GASTRIC VOLUME AND TO OBTAIN DATA THAT COULD CONTRIBUTE TO CLINICAL ANESTHESIA PRACTICES REGARDING THE RISK OF ASPIRATION.

THIS STUDY AIMS TO OBTAIN OBJECTIVE ULTRASONOGRAPHIC DATA REGARDING THE ADEQUACY OF STANDARD FASTING PERIODS IN PREGNANT WOMEN, PARTICULARLY IN THE PRESENCE OF GDM.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

DURING PREGNANCY, GASTRIC EMPTYING CAN BE AFFECTED AND THE RISK OF ASPIRATION MAY INCREASE DUE TO PHYSIOLOGICAL HORMONAL CHANGES, ELEVATED INTRA-ABDOMINAL PRESSURE, AND SLOWED GASTROINTESTINAL MOTILITY. ALTHOUGH CESAREAN SECTIONS ARE OFTEN PERFORMED UNDER REGIONAL ANESTHESIA, THEY REMAIN CLINICALLY RELEVANT IN TERMS OF ASPIRATION RISK DUE TO THE POTENTIAL NEED FOR GENERAL ANESTHESIA (1, 2).

GESTATIONAL DIABETES MELLITUS (GDM) IS A COMMON METABOLIC DISORDER DURING PREGNANCY THAT MAY AFFECT AUTONOMIC NERVOUS SYSTEM FUNCTION AND GASTROINTESTINAL MOTILITY. WHILE DIABETIC GASTROPARESIS IS WELL CHARACTERIZED IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES MELLITUS, DATA REGARDING THE EFFECT OF GDM ON GASTRIC EMPTYING DYNAMICS REMAIN LIMITED (2, 3).

IN RECENT YEARS, GASTRIC ULTRASONOGRAPHY HAS BECOME AN INCREASINGLY UTILIZED METHOD IN ANESTHESIA PRACTICE, ENABLING THE NON-INVASIVE ASSESSMENT OF GASTRIC CONTENTS AND VOLUME. THIS TECHNIQUE ALLOWS FOR THE OBJECTIVE EVALUATION OF GASTRIC CONTENTS REGARDLESS OF STANDARD FASTING INTERVALS AND FACILITATES AN INDIVIDUALIZED ASSESSMENT OF ASPIRATION RISK (3).

THE RATIONALE FOR THIS STUDY IS TO DETERMINE THE EFFECT OF GDM ON PREOPERATIVE GASTRIC VOLUME BY COMPARING GASTRIC VOLUMES MEASURED VIA GASTRIC ULTRASOUND IN PREGNANT WOMEN SCHEDULED FOR ELECTIVE CESAREAN SECTIONS, WITH AND WITHOUT A DIAGNOSIS OF GDM, THEREBY CONTRIBUTING TO PERIOPERATIVE ANESTHETIC RISK ASSESSMENT.

THIS STUDY HAS BEEN DESIGNED AS A PROSPECTIVE, OBSERVATIONAL, COMPARATIVE, AND PARALLEL-GROUP CLINICAL TRIAL

**PATIENT SELECTION:** PREGNANT WOMEN TO BE INCLUDED IN THE STUDY WILL BE SELECTED VIA A CONSECUTIVE SAMPLING METHOD (BASED ON THE ORDER OF ARRIVAL) FROM AMONG PATIENTS SCHEDULED FOR ELECTIVE CESAREAN SECTION AT GAZIANTEP CITY HOSPITAL BY THE DEPARTMENT OF ANESTHESIOLOGY AND REANIMATION AND THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, WHO MEET THE INCLUSION AND EXCLUSION CRITERIA.

PATIENTS WILL BE GROUPED SOLELY BASED ON THE PRESENCE OR ABSENCE OF GESTATIONAL DIABETES MELLITUS (GDM). NO SELECTIVE SAMPLING WILL BE PERFORMED REGARDING AGE, BODY MASS INDEX, OBSTETRIC CHARACTERISTICS, SURGICAL TEAM, OR FETAL CHARACTERISTICS.

PATIENTS WILL BE DIVIDED INTO TWO GROUPS:

  • GROUP 1:** PREGNANT WOMEN DIAGNOSED WITH GESTATIONAL DIABETES MELLITUS (GDM)
  • GROUP 2:** PREGNANT WOMEN WITHOUT A DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS (GDM) DATA REGARDING THE PATIENTS INCLUDED IN THE STUDY WILL BE OBTAINED FROM PATIENT CHARTS, HOSPITAL INFORMATION MANAGEMENT SYSTEM (HIMS) RECORDS, AND ULTRASONOGRAPHIC MEASUREMENTS PERFORMED BY THE RESEARCHER DURING THE PREOPERATIVE PERIOD. ALL DATA WILL BE PROSPECTIVELY RECORDED ON A STANDARDIZED CASE REPORT FORM.

**DATA TO BE COLLECTED:**

  • DEMOGRAPHIC DATA:** AGE, BODY MASS INDEX (BMI), GESTATIONAL AGE
  • CLINICAL DATA:** PRESENCE OF GESTATIONAL DIABETES MELLITUS (GDM), ASA PHYSICAL STATUS CLASSIFICATION, FASTING DURATIONS (SEPARATELY FOR SOLIDS AND LIQUIDS, IN HOURS), AND COMORBIDITIES
  • ULTRASONOGRAPHIC MEASUREMENTS:** ANTEROPOSTERIOR (AP) DIAMETER OF THE GASTRIC ANTRUM, CRANIOCAUDAL (CC) DIAMETER, ANTRAL CROSS-SECTIONAL AREA (CSA), AND ESTIMATED GASTRIC VOLUME (ML) DURING THE PREOPERATIVE PERIOD, THE GASTRIC ANTRUM WILL BE ASSESSED USING AN ULTRASOUND DEVICE BY AN EXPERIENCED ANESTHESIA RESIDENT OR ANESTHESIOLOGIST. THE PATIENT WILL BE EXAMINED IN BOTH THE SUPINE AND RIGHT LATERAL DECUBITUS POSITIONS. THE ANTEROPOSTERIOR AND CRANIOCAUDAL DIAMETERS OF THE GASTRIC ANTRUM WILL BE MEASURED, AND THE ANTRAL CROSS-SECTIONAL AREA WILL BE CALCULATED.

FOR PATIENTS ENROLLED IN THE STUDY, TRANSABDOMINAL GASTRIC ULTRASOUND WILL BE PERFORMED TWICE, IN TWO DIFFERENT POSITIONS, DURING THE PREOPERATIVE PERIOD. NO INTERVENTIONS WILL BE MADE REGARDING THE PLANNED MEDICAL TREATMENT OR SURGICAL PROCEDURE. ONLY NON-INVASIVE ROUTINE MEDICAL MEASUREMENTS WILL BE PERFORMED TO ASSESS THE PATIENT'S CURRENT CLINICAL STATUS.

Tipo de estudo

Observacional

Inscrição (Estimado)

54

Contactos e Locais

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Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra de Probabilidade

População do estudo

PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, GESTATIONAL AGE OF 36 WEEKS OR MORE.

Descrição

Inclusion Criteria:

  • PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY,
  • GESTATIONAL AGE OF 36 WEEKS OR MORE,
  • ASA PHYSICAL STATUS CLASSIFICATION OF II-III WILL BE INCLUDED IN THE STUDY.
  • PARTICIPANTS WILL BE SELECTED FROM PATIENTS SCHEDULED FOR ELECTIVE CESAREAN SECTION WHO HAVE BEEN INFORMED ABOUT THE OBJECTIVES AND PROCEDURES OF THE STUDY AND WHO SIGN THE INFORMED CONSENT FORM.

Exclusion Criteria:

  • EMERGENCY CESAREAN SECTION CASES.
  • MULTIPLE PREGNANCIES.
  • PATIENTS WITH GASTROINTESTINAL DISEASES, INCLUDING SYMPTOMATIC OR TREATMENT-REQUIRING GASTROESOPHAGEAL REFLUX DISEASE, PEPTIC ULCER DISEASE, ACTIVE SYMPTOMATIC GASTRITIS, A HISTORY OF DIABETIC GASTROPARESIS, INFLAMMATORY BOWEL DISEASES (CROHN'S DISEASE OR ULCERATIVE COLITIS), OR A HISTORY OF GASTROINTESTINAL SURGERY, PARTICULARLY GASTRIC OR ESOPHAGEAL SURGERY.
  • PATIENTS WITH SYSTEMIC DISEASES THAT MAY AFFECT GASTRIC MOTILITY, INCLUDING TYPE 1 OR TYPE 2 DIABETES MELLITUS (EXCLUDING GDM), UNCONTROLLED HYPOTHYROIDISM OR HYPERTHYROIDISM, NEUROLOGICAL DISEASES (E.G., PARKINSON'S DISEASE, MULTIPLE SCLEROSIS, OR AUTONOMIC NEUROPATHY), OR CONNECTIVE TISSUE DISEASES (E.G., SCLERODERMA).
  • PATIENTS WITH SEVERE SYSTEMIC COMORBIDITIES, INCLUDING ASA PHYSICAL STATUS CLASSIFICATION IV OR HIGHER, ADVANCED CARDIAC DISEASE (E.G., NYHA CLASS III-IV HEART FAILURE), ADVANCED RESPIRATORY SYSTEM DISEASE (E.G., SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE OR RESTRICTIVE LUNG DISEASE), RENAL FAILURE (STAGE 4-5 CHRONIC KIDNEY DISEASE), OR HEPATIC FAILURE (CHILD-PUGH CLASS B-C).
  • PATIENTS USING MEDICATIONS THAT MAY AFFECT GASTRIC MOTILITY, INCLUDING PROKINETIC AGENTS, ANTICHOLINERGIC DRUGS, OR OPIOIDS.
  • PATIENTS WHO REFUSE TO PARTICIPATE IN THE STUDY OR DO NOT SIGN THE INFORMED CONSENT FORM.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
GDM Group
Pregnant women with a confirmed diagnosis of gestational diabetes mellitus (per IADPSG/Carpenter-Coustan criteria) at ≥24 weeks of gestation, undergoing bedside gastric ultrasonography.
Bedside gastric ultrasound performed with a curvilinear probe in the supine and right lateral decubitus positions. The antrum is imaged in a sagittal plane at the level of the aorta; antral cross-sectional area (CSA) is measured and gastric volume is estimated using the Perlas model. Qualitative antral grading (Grade 0-2) is also recorded.
Non-GDM Group
Pregnant women without gestational diabetes, matched for gestational age and fasting duration, undergoing the same gastric ultrasonography protocol
Bedside gastric ultrasound performed with a curvilinear probe in the supine and right lateral decubitus positions. The antrum is imaged in a sagittal plane at the level of the aorta; antral cross-sectional area (CSA) is measured and gastric volume is estimated using the Perlas model. Qualitative antral grading (Grade 0-2) is also recorded.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
THE PRIMARY OBJECTIVE OF THIS STUDY IS TO COMPARE GASTRIC VOLUME PRIOR TO ELECTIVE CESAREAN SECTION BETWEEN PREGNANT WOMEN DIAGNOSED WITH GESTATIONAL DIABETES MELLITUS (GDM) AND THOSE WITHOUT GDM.
Prazo: 1 YEAR
1 YEAR

Colaboradores e Investigadores

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Patrocinador

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2026

Primeira postagem (Real)

14 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • KAEK-110

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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