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Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study (LACGDM)

29 de mayo de 2026 actualizado por: Burak Deniz Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancy: A Prospective Observational Cohort Study

Gestational diabetes mellitus (GDM) is a common metabolic disorder of pregnancy associated with increased maternal and fetal morbidity. Lactation has been suggested to improve maternal glucose metabolism, enhance insulin sensitivity, and reduce the risk of future glucose intolerance. However, evidence regarding the protective effect of lactation on the development of GDM in subsequent pregnancies remains limited.

This prospective observational cohort study aims to evaluate the association between lactation and the risk of gestational diabetes mellitus and related pregnancy complications in women who conceive during the lactation period. Routine glycemic markers including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results will be recorded. Ultrasonographic findings including fetal abdominal circumference percentile, estimated fetal weight percentile, and amniotic fluid index will also be assessed. The study will investigate whether lactation is associated with a reduced risk of GDM, fetal macrosomia, and polyhydramnios in subsequent pregnancies.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

Gestational diabetes mellitus (GDM) is one of the most common metabolic complications of pregnancy and is associated with adverse maternal and neonatal outcomes, including fetal macrosomia, polyhydramnios, cesarean delivery, and future development of type 2 diabetes mellitus. Early identification of women at increased risk of GDM is essential for optimizing antenatal care and improving pregnancy outcomes.

Lactation has been reported to exert beneficial metabolic effects through increased glucose utilization, improved insulin sensitivity, and facilitation of postpartum weight loss. Previous studies have suggested that breastfeeding may reduce the long-term risk of type 2 diabetes in women with a history of GDM. However, evidence regarding the protective effect of lactation on the occurrence of gestational diabetes mellitus in subsequent pregnancies remains limited.

The present prospective observational cohort study aims to evaluate the relationship between lactation and the development of gestational diabetes mellitus in women who become pregnant during the lactation period. Pregnant women aged 18-50 years with singleton pregnancies who attend the participating obstetrics and gynecology clinics will be enrolled. Routine laboratory parameters obtained during antenatal care, including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results, will be recorded.

In addition, routine ultrasonographic measurements, including fetal abdominal circumference percentile (AC), estimated fetal weight percentile (EFW), and amniotic fluid index (AFI), will be collected during the second and third trimesters. Maternal demographic and obstetric characteristics, including age, gravidity, parity, abortion history, and educational status, will also be documented.

The primary objective of the study is to determine whether lactation is associated with a reduced risk of gestational diabetes mellitus. Secondary objectives include evaluating the association between lactation and pregnancy complications related to altered glucose metabolism, including fetal macrosomia and polyhydramnios. The findings of this study may contribute to a better understanding of the metabolic effects of lactation and provide evidence for strategies aimed at reducing the burden of gestational diabetes mellitus in future pregnancy.

Tipo de estudio

De observación

Inscripción (Estimado)

140

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Burak D AYDOGDU, MD, OB/GYN
  • Número de teléfono: +90 5396182228
  • Correo electrónico: burakd.1992@hotmail.com

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye), 34384
        • Reclutamiento
        • Prof. Dr. Cemil Taşcıoğlu City Hospital
        • Contacto:
      • Istanbul, Turquía (Türkiye), 34517
        • Reclutamiento
        • Esenyurt Necmi Kadıoğlu State Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Pregnant individuals aged 18-50 years who conceived during the lactation period and are receiving antenatal care at participating obstetrics and gynecology clinics. Participants must have singleton pregnancies and available routine glycemic and ultrasonographic follow-up data. The study population represents women undergoing standard prenatal care in a tertiary care and secondary care hospital setting.

Descripción

Inclusion Criteria:

  • Pregnant individuals aged 18 to 50 years.
  • Singleton pregnancy.
  • Conception during the lactation period.
  • Follow-up at Prof. Dr. Cemil Taşcıoğlu City Hospital or Esenyurt Necmi Kadıoğlu State Hospital.
  • Availability of glycemic parameters including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results.
  • Availability of routine ultrasonographic measurements including fetal abdominal circumference percentile (AC), estimated fetal weight percentile (EFW), and amniotic fluid index (AFI).

Exclusion Criteria:

  • Age below 18 years.
  • Age above 50 years.
  • Multiple pregnancy.
  • Known chronic systemic disease or pre-existing diabetes mellitus.
  • Missing clinical, laboratory, or ultrasonographic data.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Pregnant Women During Lactation Period
Singleton pregnant women aged 18-50 years who conceived during the lactation period and were followed at participating obstetrics and gynecology clinics.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Gestational Diabetes Mellitus
Periodo de tiempo: 24-28 weeks of gestation
Occurrence of gestational diabetes mellitus diagnosed by the 75-g oral glucose tolerance test performed between 24 and 28 weeks of gestation.
24-28 weeks of gestation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fetal Macrosomia
Periodo de tiempo: From second trimester until delivery
Presence of fetal macrosomia assessed according to routine obstetric ultrasonographic evaluation and/or birth weight.
From second trimester until delivery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Polyhydramnios
Periodo de tiempo: From second trimester until delivery
Development of polyhydramnios determined by routine ultrasonographic assessment of amniotic fluid volume during pregnancy.
From second trimester until delivery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de enero de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared because the study involves patient-level clinical data collected from routine medical records. Data sharing is not included in the current study protocol or ethics committee application, and participant confidentiality and institutional data protection policies will be maintained.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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