Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study (LACGDM)
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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Burak D AYDOGDU, MD, OB/GYN
- Número de telefone: +90 5396182228
- E-mail: burakd.1992@hotmail.com
Locais de estudo
-
-
-
Istanbul, Turquia (Türkiye), 34384
- Recrutamento
- Prof. Dr. Cemil Taşcıoğlu City Hospital
-
Contato:
- Burak d AYDOGDU, MD
- Número de telefone: 90 5396182228
- E-mail: burakd.1992@hotmail.com
-
Istanbul, Turquia (Türkiye), 34517
- Recrutamento
- Esenyurt Necmi Kadıoğlu State Hospital
-
Contato:
- Burak d AYDOGDU, MD
- Número de telefone: +90 5396182228
- E-mail: burakd.1992@hotmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Gestational Diabetes Mellitus
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fetal Macrosomia
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Polyhydramnios
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LAC-GDM-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .