Esomeprazole to treat women with preterm preeclampsia: A randomised placebo controlled trial
American Journal of Obstetrics and Gynecology Aug 02, 2018
Cluver CA, et al. - Whether or not esomeprazole could prolong pregnancy in women diagnosed with preterm preeclampsia was determined. Findings revealed no prolongation of gestation in pregnancies with preterm preeclampsia or decrease in circulating sFlt-1 concentrations on administering 40mg of daily esomeprazole. Clinical effect might be observed with its higher levels in the maternal circulation.
Methods
- At Tygerberg Hospital in South Africa, researchers performed a double blind, randomised controlled trial.
- They randomly assigned women with preterm preeclampsia (gestational age 26 weeks+0 days to 31 weeks+6 days) to 40 mg daily esomeprazole or placebo.
- A prolongation of gestation of five days was assessed as the primary outcome.
- Maternal and neonatal outcomes were assessed as secondary outcomes.
- They performed a comparison of circulating markers of endothelial dysfunction associated with preeclampsia and undertook pharmacokinetic studies.
Results
- One hundred and twenty participants were recruited between January 2016 and April 2017.
- Due to incorrect randomisation, researchers excluded 1 participant leaving 59 in the esomeprazole, and 60 in the placebo group.
- At enrolment, median gestational age of 29+4 weeks gestation was noted.
- They recognized no between-group differences in median time from randomization to delivery (11·4 days [interquartile range, 3·6-19·7]) in the esomeprazole group, and 8·3 days [interquartile range, 3·8-19·6] in the placebo group (3 days longer in the esomeprazole arm, 95% confidence interval -2·9-8·8, P=0·31).
- No placental abruptions in the esomeprazole group and 6 (10%) in the placebo group (P=0·01, P=0·14 adjusted) were reported.
- Other maternal or neonatal outcomes, or markers of endothelial dysfunction was not different between the groups.
- Women treated with esomeprazole had esomeprazole and its metabolites in blood, but had only in trace amounts in the umbilical cord blood.
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