Angiogenic markers in preeclampsia
Conditions
Interventions
Trade Name: Omeprazol
Product Name: Omeprazol
Pharmaceutical Form: Capsule
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with (= 18 years) with a singleton pregnancy diagnosed with PE with a gestational age of =20 weeks and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Multiple pregnancies Not willing to give written informed consent Other reasons than 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 =2 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether PPI administration (omeprazole) to women with confirmed PE significantly lowers circulating sFlt-1 levels;Secondary Objective: 1. Effects of PPI administration on circulating PlGF (elevation), sEndoglin (decrease), ET-1 (decrease) and CT-proET-1 (decrease) levels. 2. Effects of PPI administration on cord blood sFlt-1, PlGF, sEndoglin, ET-1 and CT-proET-1 levels;Primary end point(s): The difference in sFlt-1 levels in women who have received PPI, in comparison to women who have not received PPI, at different time points.;Timepoint(s) of evaluation of this end point: After delivery evaluation of the primary outcome will take place | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The change in serum levels of PlGF, sEndoglin, ET-1 and CT-proET-1 levels between PPI and non-PPI group at different time points (before and after administration) 2. The change in cord blood levels of sFlt-1, PlGF, sEndoglin, ET-1 and CT-proET-1 at time of delivery between PPI and non-PPI group. 3. Blood pressure regulation and the need for blood pressure medication between PPI group and non-PPI group. 4. Days until delivery between PPI group and non-PPI group.;Timepoint(s) of evaluation of this end point: After delivery evaluation of the secondary outcome will take place. | — |
Countries
Netherlands
Outcome results
None listed