Preeclampsia Intervention with Esomeprazole (PIE) trial
- Conditions
- Pregnancy and ChildbirthPreeclampsia
- Registration Number
- PACTR201504000771349
- Lead Sponsor
- niversity of Stellenbosch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prolongation of gestation
- Secondary Outcome Measures
Name Time Method Improved fetal, neonatal and maternal outcomes;Serum sFlt-1 and sEng levels;Safety and tolerability of esomeprazole