Two studies (1, 2) have suggested that taking metformin prior to pregnancy may decrease the risk of hyperemesis gravidarum during pregnancy.
These studies show a correlation, and we are proud to be a clinical study site for Hyperemesis Gravidarum Risk Reduction With Metformin, which we hope will prove that metformin decreases HG risk.
Clinical trial: Hyperemesis Gravidarum Risk Reduction With Metformin
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We know that HG is directly related to the rapid rise of GDF15 in early pregnancy. GDF15 is a nausea and vomiting hormone produced in high concentrations by the placenta. Women with low GDF15 before pregnancy (from genetic variants) react strongly to the rapid rise of this protein, which can trigger HG.
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The hypothesis this study is testing is that raising GDF15 levels prior to pregnancy with metformin will decrease the risk of HG in patients who experienced severe nausea and vomiting in prior pregnancies.
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For anyone living in Alabama or California, we are actively recruiting individuals into the metformin arm of the trial. If you are between 18 and 49 years of age, have had HG in a previous pregnancy, and are planning to become pregnant again, you may be eligible to participate in the trial.
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You may be eligible if you are between 18-49 years old, experienced HG in a prior pregnancy, and are planning to become pregnant again.
Eligible patients will receive compensation.Text us at 205-772-9595 if you would like more information about this study.
Take this participation survey to see if you are eligible.
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If you are living outside of Alabama and California, the HER Foundation is recruiting individuals for the comparison arm of the trial who will not take metformin. You can read more here.
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If you decide to participate in the study at our clinic, you will be asked to do the following:
Complete an initial online survey
Come to The Morning Sickness Clinic for three in-person visits. You will have blood drawn at each visit.
Take metformin daily, increasing the dose over a few month period, and continuing taking it for 12 months or until you become pregnant. Metformin is the study medication, and Dr. Housholder will discuss this with you prior to entering the study.
Short daily log to track metformin use and symptoms (5 mins each)
Symptom surveys at scheduled timepoints (up to four, 5 mins each)
Brief check ins with study staff throughout participation
After pregnancy, release medical records related to pregnancy/neonatal outcomes
Completion of outcome surveys postpartum (around 2 hours)
Optional: additional follow-up survey every 6 months until the end of the trial (5 years total) to assess child health/development (around 30 mins)
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You can also visit https://clinicaltrials.gov/study/NCT07129473 to review additional study information.