E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Angiogenic markers in preeclampsia |
Angiogene markers in preeclampsie |
|
E.1.1.1 | Medical condition in easily understood language |
Biomarkers in toxemia of pregnancy |
Biomarkers in zwangerschapsvergiftiging |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether PPI administration (omeprazole) to women with confirmed PE significantly lowers circulating sFlt-1 levels |
Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), een significante daling veroorzaakt van de sFlt-1 waarde. |
|
E.2.2 | Secondary objectives of the trial |
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 |
1. Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), effect heft op de angiogene markers; PlGF, sEng, ET-1 en CT-proET-1.
2. Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), effect heft op de angiogene markers in navelstrengbloed; PlGF, sEng, ET-1 en CT-proET-1 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women with (≥ 18 years) with a singleton pregnancy diagnosed with PE with a gestational age of ≥20 weeks and <34 weeks admitted to the obstetric department who give written informed consent, will be included. |
Vrouwen (≥ 18 jaar) met een eenlingzwangerschap en preeclampsie (zwangerschapsduur tussen ≥20 weken en <34 weken) opgenomen op de afdeling Verloskunde. |
|
E.4 | Principal 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 |
Meerlingzwangerschap
Geen toestemming
Andere opnameindicatie dan preeclampsie
Contraindicatie of hypersensitiviteit voor PPI
Het gebruik van medicatie dat invloed heeft op PPI
Foetale dood
Foetale nood ten tijde van inclusive
Verwachte bevallingsdatum ≤2 dagen |
|
E.5 End points |
E.5.1 | 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. |
Het verschil in sFlt-1 waarde op verschillende tijdstippen tussen de interventie (PPI) en controlegroep |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After delivery evaluation of the primary outcome will take place |
Na de bevalling zal analyse van de primaire uitkomstmaat plaatsvinden |
|
E.5.2 | 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. |
1. Het verschil in PlGF, sEndoglin, endothelin-1 (ET-1) en CT-proET-1 waarde tussen de interventie (PPI) en controlegroep.
2. Het verschil in PlGF, sEndoglin, endothelin-1 (ET-1) en CT-proET-1 waarde tussen de interventie (PPI) en controlegroep in navelstrengbloed.
3. Het verschil in bloeddrukregulatie en bloeddrukmedicatie gebruik tussen interventie (PPI) en controlegroep.
4. Het aantal dagen tot de bevalling tussen de interventie (PPI) en controlegroep |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After delivery evaluation of the secondary outcome will take place. |
Na de bevalling zal analyse van de secundaire uitkomstmaat plaatsvinden. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Geen PPI medicatie |
No PPI medication |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Laatste bevalling van laatste deelnemer |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |