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Clinical Research

Brief Summary

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

Detailed 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.

MaMome Science & Technology Overview

Critical Need

The maternal morbidity rate in the United States and around the world poses a significant health challenge. The U.S. experiences higher rates of maternal morbidity and mortality compared to other developed countries, with complications arising from conditions like gestational diabetes mellitus (GDM) and preeclampsia. Globally, the risk is even more pronounced, with limited access to quality healthcare exacerbating the situation. This disparity underscores the urgent need for innovative solutions and better research to support maternal health. Improving diagnostic tools, providing evidence-based interventions, and enhancing structural support for expectant and new mothers are critical to addressing these risks and improving health outcomes for women and their infants worldwide.

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Technology Vision

At MaMome, we are committed to addressing these critical needs with innovative technology solutions aimed at improving maternal and infant health. Our advancements include: Microbiome-Based Diagnostic Tools: Our cutting-edge diagnostics assess and modify the gut microbiome for pregnant women, enhancing health outcomes. Early Detection and Patient Outcomes: This includes personalized nutrition plans to optimize the gut microbiome during pregnancy. Designed to facilitate the early detection of gestational diabetes mellitus (GDM) through microbiome analysis, our technologies are backed by our recent SBIR Phase I Grant. This allows for timely interventions and improved patient outcomes.

Potential for Impact

MaMome aims to revolutionize maternal health care by providing robust, science-based solutions that support pregnant women and their infants. Our technology enhances early detection and patient outcomes while empowering parents with the knowledge and tools needed for optimal health. By improving access to personalized nutrition and advanced diagnostics, we strive to support breastfeeding practices, enhance infant health, and provide valuable insights into maternal and infant well-being.

We envision a future where our technology transforms maternal health practices, reduces healthcare disparities, and fosters a supportive environment for all families.

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