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ID
Source
Brief title
Health condition
Preeclampsia
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in sFlt-1 levels in women who have received PPI, in comparison to women who have not received PPI.
Secondary outcome
The difference in other biomarkers such as PlGF, ET-1, sEndoglin, CT-proET-1 in women who have received PPI, in comparison to women who have not received PPI
Background summary
Rationale: Preeclampsia (PE) is a devastating complication of pregnancy. The pathogenesis of PE is unknown. Recent data suggest an angiogenic imbalance characterized by elevated placenta-derived soluble Fms-like tyrosine kinase-1 (sFlt-1) and decreased placental growth factor (PlGF) levels in the maternal circulation. As a consequence, novel therapies now focus on sFlt-1 removal or PlGF supplementation. Given the fact that heme-oxygenase-1 negatively regulates sFlt-1 secretion, a role for proton pump inhibitors (PPIs) that upregulate heme oxygenase-1, has been suggested as potential treatment for preeclampsia. Indeed, Onda et al. observed that PPIs decreased sFlt-1 secretion from trophoblasts and reduced blood pressure in a transgenic PE mouse model with placental sFlt-1 overexpression. Recently, we reported that women with suspected/confirmed PE using PPIs, displayed lower levels of sFlt-1 in comparison to women not using PPIs.
In this study, our aim is to evaluate the potential effect of PPI administration in women with confirmed preeclampsia on sFlt-1 levels until delivery. Study design will be a single-centre, randomized, intervention proof-of-concept study performed at the Erasmus MC Rotterdam. Study population will consist of women with confirmed PE with a gestational age ≥ 20 weeks and <35 weeks who did not use PPIs at study entrance.
The intervention group will receive omeprazole, 40mg, once daily while the control group will receive no medication. In both groups, blood will be drawn at several time points, until delivery.
Study objective
PPI administration to women with confirmed PE lowers sFlt-1 levels and which may lead to less complications or progression of disease.
Study design
Measurements of sFlt-1 will be performed on day 0 (before PPI use), 1, 2, 4, 8 and thereafter twice weekly until delivery
Intervention
Omeprazole 40mg once daily
Inclusion criteria
Women (≥18 years) with a singleton pregnancy diagnosed with PE with a gestational age of ≥ 20 weeks and <35 weeks admitted to the obstetric department who give written informed consent, will be included.
Exclusion criteria
- Multiple pregnancies
- Not willing to give written informed consent.
- Other reasons than (suspected) PE requiring hospitalization
- The use of PPI at time of randomization
- Contraindications or hypersensitivity to PPI use
- The use of medication affected by PPI
- Fetal death at time of inclusion
- Signs of fetal distress at time of inclusion
- Expected delivery of ≤ 2 days
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7718 |
| Other | METC EMC : MEC2018-078 |