Pregnancy Complications Clinical Trial
Official title:
A Single Site, Observational, Administered to Pregnant Women at High Risk for Gestational Diabetes Mellitus
The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 31, 2024 |
Est. primary completion date | February 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Long Island University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Long Island University | BROOKLYN INNOSEQ INC. |
United States,
Hasan S, Aho V, Pereira P, Paulin L, Koivusalo SB, Auvinen P, Eriksson JG. Gut microbiome in gestational diabetes: a cross-sectional study of mothers and offspring 5 years postpartum. Acta Obstet Gynecol Scand. 2018 Jan;97(1):38-46. doi: 10.1111/aogs.1325 — View Citation
Moses RG. The recurrence rate of gestational diabetes in subsequent pregnancies. Diabetes Care. 1996 Dec;19(12):1348-50. doi: 10.2337/diacare.19.12.1348. — View Citation
Su M, Nie Y, Shao R, Duan S, Jiang Y, Wang M, Xing Z, Sun Q, Liu X, Xu W. Diversified gut microbiota in newborns of mothers with gestational diabetes mellitus. PLoS One. 2018 Oct 17;13(10):e0205695. doi: 10.1371/journal.pone.0205695. eCollection 2018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy | Up to approximately GA Week 37 | ||
Secondary | Global Clinical Outcome (GCO) Rank Score (GCO Rank) | Up to approximately GA Week 37; up to approximately 12 weeks post birth | ||
Secondary | Number of Participants With OGTT Oral Glucose Intolerance Test | Up to approximately GA Week 37 | ||
Secondary | Number of Participants With live Birth | Up to approximately GA Week 37 | ||
Secondary | Number of Participants With Preterm Birth | Up to approximately GA Week 37 | ||
Secondary | Number of Participants at GA Week 24 Without an OGTT | GA Week 24-28 | ||
Secondary | Gestational age at First GDM | Up to approximately GA Week 37 | ||
Secondary | Gestational age at First Preeclampsia | Up to approximately GA Week 37 | ||
Secondary | Gestational age at Delivery | Up to approximately GA Week 37 |
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