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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Age below 18 years.

Age above 50 years.

Multiple pregnancy.

Known chronic systemic disease or pre-existing diabetes mellitus.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 1 trial group
Group A: Pregnant Women During Lactation Period

Trial outcomes

Primary outcomes

1

Incidence of Gestational Diabetes Mellitus

Occurrence of gestational diabetes mellitus diagnosed by the 75-g oral glucose tolerance test performed between 24 and 28 weeks of gestation.

Time frame
24-28 weeks of gestation

Secondary outcomes

1

Fetal Macrosomia

Presence of fetal macrosomia assessed according to routine obstetric ultrasonographic evaluation and/or birth weight.

Time frame
From second trimester until delivery

Other outcomes

1

Polyhydramnios

Development of polyhydramnios determined by routine ultrasonographic assessment of amniotic fluid volume during pregnancy.

Time frame
From second trimester until delivery

Sponsors and contacts

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