Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Metformin
Placebo
Sponsors
Mercy Perinatal
Eligibility
Sex/Gender
Female
Inclusion criteria
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 problems for the patient or that require specific surgical or medical management. Major anomalies or malformations are not considered a variation of the normal spectrum. ¿ The mother must be able to understand the information provided, with the use of an interpreter if needed ¿ The mother must be able to give informed consent ¿ Patient will be admitted to hospital for expectant management and standardised care
Exclusion criteria
Exclusion criteria: Patient is unable or unwilling to give consent Established fetal compromise that necessitates delivery. This will be decided by the clinical team before expectant management is offered to the patient. The presence of any of the following at presentation: Eclampsia defined as the new onset of grand mal seizure activity and/or an unexplained coma during pregnancy with signs or symptoms of pre-eclampsia(41). Severe hypertension defined as a systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 110 mmHg that cannot be controlled with antihypertensive medication within 48 hours of admission. Cerebrovascular event defined as an ischaemic or haemorrhagic stroke associated with clinical symptoms and definitive signs on imaging. Posterior reversible encephalopathy syndrome (PRES) associated with pre-eclampsia defined on imaging as reversible vasogenic oedema, usually in the occipital or parietal lobes. Severe renal impairment with a creatinine level of greater or equal to 125 ¿mol/l or a need for dialysis. Signs of left ventricular failure which include pulmonary oedema requiring treatment or oxygen saturations of less than 90% caused by left sided heart failure. Disseminated intravascular coagulation defined as an INR greater than 2 Platelet count at presentation less than 50x109 (platelet aggregation excluded) Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome defined as a platelet count less than 100 × 109/L, aspartate aminotransferase greater than 60, and haemolysis as demonstrated by lactate dehydrogenase > 600 or haemolysis on a peripheral blood smear or a raised haptoglobin level) Liver transaminases greater than or equal to 500IU/L Liver haematoma or rupture Fetal distress on cardiotocography Severe ascites on ultrasound as defined by the sonographer Contra-indications for expectant management of pre-eclampsia Current use of metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
South Africa
Contacts
Public ContactCluver Catherine
Obstetrician and Gynaecologist
Outcome results
None listed