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Gestational Diabetes Mellitus (GDM) in Pregnant Women

Gestational Diabetes Mellitus (GDM) in Pregnant Women

Non Recruiting
18-45 years
Female
Phase N/A

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Overview

The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester.

Description

Gestational Diabetes Mellitus (GDM) is a type of diabetes that affects pregnant women and often develops in the middle and later stages of pregnancy. GDM can lead to adverse maternal outcomes such as preeclampsia, and postpartum hemorrhage, and undesirable infant outcomes such as macrosomia and neonatal hypoglycemia. GDM also increases the risk of long-term consequences such as the development of type 2 diabetes in mothers, metabolic syndrome, and cardiovascular diseases. Gut microbiota has been shown to play a significant role in the etiology of metabolic illnesses, and recent studies have demonstrated that the gut microbiota of GDM women is altered compared to those of healthy women.

This trial aims to identify biomarkers during the first trimester (week 8-week 12) that can predict the likelihood of developing GDM while also examining potential links between GDM and gut microbiota. To achieve these objectives, the investigators have designed a trial that involves the collection of fecal samples from pregnant women for microbiome analysis at different stages of pregnancy. Although GDM is diagnosed at or after 24 weeks, the investigators will collect samples at the first, second, and third trimesters to determine if any alterations in the microbiome occur prior to symptom onset.

Eligibility

Inclusion Criteria:

        Women between the age of 18-45 Groups A and B have to be confirmed pregnant by blood test
        (confirmed by medical records) Subgroups A1 and B1 are pregnant women in their first
        trimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 and
        B3 are pregnant women in their third trimester
        Exclusion Criteria:
        History of smoking or drinking during the pregnancy History of chronic diseases (cardiac,
        kidney, diabetes, hypertension, IBD,etc). Laxative use within 2 days prior to sample
        collection (The participant will be informed of the collection procedure by the recruiter
        and will be made aware of this requirement, we will also confirm when the first sample is
        taken through a phone call if for any reason the participant still made a mistake, will ask
        her to collect another sample to replace it) Development of any serious pregnancy
        complication during the participation period (e.g preeclampsia, preterm birth, miscarriage,
        etc) Excessive vomiting, diarrhea, or gastrointestinal symptoms for more than 5 consecutive
        days during the participation period. This will be confirmed through a weekly check-up call
        by the on-site recruiter or by Dr.Yin if the patient seeks treatment

Study details
    Gestational Diabetes Mellitus
    Pregnancy Complications

NCT05265741

Long Island University

20 August 2025

FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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