Preeclampsia Intervention 4

INTERVENTION: Product Name: Glucophage SR 500mg prolonged release tablet,Product Code: PRD338487,Pharmaceutical Form: PROLONGED‐RELEASE TABLET,Other descriptive name: ,Strength: Metformin Hydrochloride 500mg,Product Name: Glucophage XR 500 mg RM Placebo,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A CONDITION: Preeclampsia Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:To examine whether 3 grams of metformin ER daily can prolong gestation in pregnancies complicated by preterm preeclampsia diagnosed 22+0–33+6 weeks in women undergoing expectant management, compared to placebo. Primary end point(s):The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery. Secondary Objective:To determine whether 3 grams of metformin ER daily can reduce the time from birth to discharge from neonatal care in neonates born to women with preterm preeclampsia diagnosed at 22+0–33+6 weeks undergoing expectant management, compared to placebo.,To determine whether 3 grams of metformin ER daily can increase neonatal birthweight of neonates born to women with preterm preeclampsia diagnosed at 22+0–33+6 weeks undergoing expectant management, compared to placebo. SECONDARY OUTCOME: Secondary end point(s):Length of neonatal stay, defined as days and hours from birth to discharge from neonatal care, including both hospital and home‐based care. Length of neonatal stay will be as zero if the infant was not admitted to neonatal care. Secondary end point(s):Neonatal birthweight, in grams. INCLUSION CRITERIA: • A diagnosis of preeclampsia has been made by the attending clinician,• The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours,• The subject has given written consent to participate in the study.,• The woman must be 18 years of age or older,• The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus,• The woman carries a singleton pregnancy