Metformin to Prevent Preterm Birth in Twin Pregnancy (TwinMet)
Preterm Birth, Premature Obstetric Labor, Twin; Complicating Pregnancy
About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- All women age ≥ 18 years old
- Viable twin pregnancy with dichorionic diamnioticity or monochorionic diamnioticity
- Gestational age less than 20 completed weeks
Exclusion Criteria:
- High order multiple pregnancy such as triplets or higher order multiple pregnancy with fetal reduction to twin pregnancy
- Monochorionic monoamniotic twin pregnancy
- Twin pregnancy with silent miscarriage of one twin
- Excessive vaginal bleeding
- Presence of congenital anomaly
- Rupture of membranes
- Congenital uterine anomaly
- Unwillingness or inability to comply with study procedures
- Known paternal or maternal abnormal karyotype
- Known renal, liver, or heart failure
- Pre-existing type 1 or 2 diabetes
- Treatment with metformin at the time of screening
- Allergic to metformin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Metformin
Placebo
Metformin will be prescribed before 20 weeks to 33+6 weeks, started at a daily dose of 500mg in the first week, and the daily dose is increased by 500mg per week to a maximum of 2000mg in week 4 (1000mg twice per day). Women will be asked to take the maximum tolerated dose if they experience side effects from the medication.
Placebo will be prescribed before 20 weeks to 33+6 weeks, started at a daily dose of 1 tablet in the first week, and the daily dose is increased by 1 tablet per week to a maximum of 4 tablets in week 4 (2 tablets twice per day). Women will be asked to take the maximum tolerated dose if they experience side effects from the medication.