At Tygerberg Hospital we would not consider a pregnancy to be viable under 500?g and we would not offer expectant management if the fetal weight was above 1800?g
At Tygerberg Hospital we would not consider a pregnancy to be viable under 500?g and we would not offer expectant management if the fetal weight was above 1800?g. To be eligible for this study, the treating clinicians need to have made an initial assessment and deemed that the patient is suitable for expectant management, that this fetus would benefit from expectant management and that immediate delivery is not SU14813 double bond Z required. who will be randomised to receive either esomeprazole or an identical placebo. The primary outcome will be the number of days SU14813 double bond Z from randomisation to delivery. Secondary outcomes include maternal, fetal and neonatal composite and individual outcomes. Maternal outcomes include maternal death, eclampsia, pulmonary oedema, severe renal impairment, cerebral vascular events and liver haematoma or rupture. Neonatal outcomes include neonatal death within 6?weeks after the due date, intraventricular haemorrhage, necrotising enterocolitis and bronchopulmonary SU14813 double bond Z dysplasia. We will examine whether esomeprazole can decrease serum sFlt-1 and soluble endoglin levels and we will record the safety of esomeprazole Rabbit Polyclonal to SYT11 in these pregnancies. Ethics and dissemination This study has ethical approval (Protocol V.2.4, M14/09/038, Federal Wide assurance Number 00001372, IRB0005239), and is registered with NHREC (ID 3649) and the Pan African Clinical Trial Registry (PACTR201504000771349). Data will be presented at international conferences and published in peer-reviewed journals. strong class=”kwd-title” Keywords: PERINATOLOGY Strengths and limitation of this study This is a protocol for a randomised, double blind, placebo controlled clinical trial. This is the first trial to assess whether esomeprazole is usually a treatment option for pre-eclampsia. We plan to recruit 120 participants and we have designed this study to be sufficiently powered to identify a prolongation of pregnancy. It may be underpowered to show improvements in maternal and perinatal outcomes. Therefore, if the trial yields a positive result, a larger subsequent multicentre study may be needed. Introduction Pre-eclampsia is one of the most serious complications of pregnancy, affecting 3C8% of pregnancies worldwide and is a leading cause of maternal and fetal/neonatal morbidity.1C3 Pre-eclampsia is estimated to cause more than 60?000 maternal deaths annually.4 There is no treatment that can quench the disease progression and the only treatment option available to arrest the disease is delivery of the pregnancy.5 For pre-eclampsia occurring at preterm gestations, clinicians are often forced to deliver early on maternal indications to prevent major maternal morbidity, but in doing so, inflict severe prematurity around the fetus. In particular, fetuses delivered at less than 33?weeks gestation are at significant SU14813 double bond Z risk of severe disability including cerebral palsy, stroke (intracerebral bleeding), retinopathy of prematurity, chronic lung disease and death. 6 7 If an affordable and safe treatment was available that could temporise the disease progression of pre-eclampsia, clinicians could safely delay delivery and gain gestation to improve fetal outcome. This may save the entire lives of several infants and reduce the hospital burden due to iatrogenic prematurity. Such cure would be commensurate with the US Millennium Advancement Goals to lessen kid mortality and improve maternal wellness.8 The pre-eclamptic placenta produces antiangiogenic soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng) in to the maternal blood flow. These factors are in charge of causing wide-spread maternal endothelial organ and dysfunction injury observed in medical disease.9 Furthermore, pre-eclampsia is connected with placental and systemic oxidative tension strongly. Esomeprazole is a proton pump inhibitor used to take care of ladies with gastric reflux in being pregnant widely. Large observational research including administration through the first, third and second trimesters never have determined organizations with undesirable being pregnant results, teratogenesis notably.10C12 We’ve performed preclinical lab studies where we’ve identified esomeprazole like a promising applicant therapeutic for pre-eclampsia. Esomeprazole reduced sFlt-1 and sEng secretion from placenta and endothelial cells potently, has strong activities mitigating endothelial dysfunction and offers antioxidant properties. (A manuscript reporting this preclinical data continues to be submitted elsewhere which work was lately presented.)13 Goals The primary goal can be to examine whether an individual daily dosage of 40?mg of esomeprazole may prolong gestation in ladies with early starting point pre-eclampsia diagnosed 26+0C31+6 safely? weeks who expectantly are becoming managed, weighed against expectant management only. The secondary goals are to determine.