Pregnancy and Childbirth Preeclampsia
Conditions
Interventions
Esomeprazole
Control
Sponsors
University of Stellenbosch
Discovery Foundation
South African Medical Association
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Diagnosis of preeclampsia, super-imposed preeclampsia unclassified or proteinuric hypertension AND all of the following Gestational age between 26 + 0 weeks and 31 + 6 weeks Estimated fetal weight by ultrasound between 500gm and 2000gm, (if gestation is not certain) Singleton pregnancy The managing clinicians have made the initial assessment at initial diagnosis to proceed with expectant management and that delivery is not expected within 48 hours The managing clinician and neonatologist believe that the fetus could be potentially delivered viable No suspicions of a major fetal anomaly 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 standardized care
Exclusion criteria
Exclusion criteria: Patient is unable or unwilling to give consent Established fetal compromise that necessitates delivery The presence of any of the following at presentation: 1.Eclampsia 2.Severe hypertension (systolic blood pressure greater than 170 or diastolic blood pressure greater than 110) that cannot be controlled with antihypertensive medication within 48 hours of admission 3.Cerebrovascular event 4.Severe renal impairment needing delivery 5.Haemolysis 6.Signs of left ventricular failure (pulmonary oedema requiring treatment; oxygen saturations of less than 95% caused by left sided heart failure) 7.Disseminated intravascular coagulation 8.Platelet count at presentation less than 50x109 (platelet aggregation excluded) 9.Haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome defined as a platelet count less than 100 × 109/L, aspartate aminotransferase greater than 40 ¿/L, alanine aminotransferase greater than 53 ¿/L and haemolysis as demonstrated by lactate dehydrogenase > 350 ¿/L or haemolysis on a peripheral blood smear or a raised haptoglobin level) 10.Liver transaminases >300IU/L; 11.Liver haematoma 12.Fetal distress on cardiotocography 13.Severe ascites on ultrasound Contraindications for expectant management of pre-eclampsia Current use of a proton pump inhibitor Contraindications to the use of a proton pump inhibitor Previous hypersensitivity reaction to a proton pump inhibitor Current use of a drug that may be affected by a proton pump inhibitor: warfarin, ketoconazole, voriconazole, atazanavir, nelfinavir, saquinavir, digoxin, St John¿s Wort, rifampin, cilostazol, diazepam, tacrolimus, erlotinib, methotrexate and clopidogrel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prolongation of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved fetal, neonatal and maternal outcomes;Serum sFlt-1 and sEng levels;Safety and tolerability of esomeprazole | — |
Countries
South Africa
Contacts
Public ContactCatherine Cluver
Consultant Obstetrician and Gynaecologist
Outcome results
None listed