Pre-eclampsia Intervention 2 (PI2) trial: a double blind randomised control trial of metformin for the treatment of early onset pre-eclampsia

INTERVENTION: Metformin Placebo CONDITION: ; Pregnancy and Childbirth ; Pre‐eclampsia Pre‐eclampsia Pregnancy and Childbirth PRIMARY OUTCOME: To examine whether metformin can safely prolong gestation in women with early onset pre‐eclampsia diagnosed 26+0 ¿ 31+6 weeks who are being managed expectantly compared to expectant management alone SECONDARY OUTCOME: To determine whether metformin can improve 1) maternal 2) fetal and 3) neonatal outcomes in early onset pre‐eclampsia being managed expectantly compared to expectant management alone To examine whether metformin can significantly decrease levels of circulating sFlt‐1 and/or sEng in women with early onset pre‐eclampsia who are being managed expectantly compared to expectant management alone INCLUSION CRITERIA: A diagnosis of pre‐eclampsia, gestational hypertension with evidence of preeclampsia, preexisting hypertension with evidence of pre‐eclampsia or unclassified proteinuric hypertension has been made by the attending clinician who is of the opinion that the patient and fetus would benefit from expectant management. AND all of the following is present: ¿ Gestational age between 26 + 0 weeks and 31 + 6 weeks ¿ Estimated fetal weight by ultrasound between 500gm and 1800 gm (if gestation is not certain) ¿ Singleton pregnancy ¿ The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours ¿ The managing clinician and neonatologist believe that the fetus could potentially be delivered in a viable condition ALSO: ¿ No suspicions of a major fetal anomaly or malformation. A major fetal anomaly is defined as anomalies or malformations that create significant medical p