Hyperemesis Gravidarum Risk Reduction With Metformin
Status:
NOT_YET_RECRUITING
Trial end date:
2030-10-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to pregnancy, can reduce the risk and severity of Hyperemesis Gravidarum (HG)-a severe nausea and vomiting condition in pregnancy-in individuals aged 18-49 who have experienced HG in a previous pregnancy and are trying to conceive.
The main questions it aims to answer are:
Is metformin-XR acceptable and well-tolerated when taken by non-pregnant individuals trying to conceive?
Does pre-pregnancy metformin-XR use reduce HG recurrence and symptom severity in a subsequent pregnancy?
Researchers will compare a metformin treatment group to a survey-only comparator group to see if metformin-XR is associated with improved outcomes, including lower recurrence of HG and better maternal and neonatal health indicators.
Participants will:
Complete online questionnaires before and during early pregnancy
(Treatment group only) Take daily metformin-XR and attend three brief study visits
(Treatment group only) Undergo blood draws for GDF15 and safety labs at specified timepoints