224
Participants
Start Date
October 31, 2025
Primary Completion Date
October 31, 2029
Study Completion Date
October 31, 2030
Metformin Extended Release Oral Tablet
"Participants in the Treatment Arm will receive oral extended-release metformin (metformin-XR) once daily with the evening meal starting prior to conception. The dosing will begin at 500 mg daily and increase gradually over an eight week period (+500mg every 2 weeks, as tolerated) to a maximum tolerated dose of up to 2,000 mg daily. Treatment at highest tolerated dose will continue (maintenance phase) until either two weeks after a positive pregnancy test or 12 months from treatment initiation, whichever comes first. Participants will attend three clinic visits and provide blood samples at baseline, after dose escalation, and during early pregnancy to assess GDF15 levels. Daily dosing, adherence, and any side effects are recorded via MyCap; clinical visits at baseline, post-escalation (week 8), and after pregnancy confirmation include vital signs, PUQE-24/HELP scores, and blood draws for CBC, creatinine, and GDF15 levels."
The Morning Sickness & HG Clinic
UNKNOWN
University of Southern California
OTHER