To evaluate the potential effect of PPI administration in women with confirmed preeclampsia on sFlt-1 levels until delivery.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
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 PlGF levels as well as sEndoglin and ET-1 levels in women who
have received PPI, in comparison to women who have not received PPI.
The difference in cord blood PlGF levels as well as sEndoglin and ET-1 levels,
in women who have received PPI in comparison to women who have not received PPI.
Blood pressure regulation and the need for blood pressure medication between
PPI group and non-PPI group.
Days until delivery between PPI group and non-PPI group.
Difference in preeclampsia-related complications between PPI group and non-PPI
group as defined by maternal complications and/or fetal/neonatal complications
(as described in the research protocol)
Background summary
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 about 60% lower levels of sFlt-1
in comparison to women not using PPIs.
Study objective
To evaluate the potential effect of PPI administration in women with confirmed
preeclampsia on sFlt-1 levels until delivery.
Study design
A multi-centre, randomized, intervention proof-of-concept study. The study will
be performed at the Erasmus MC-Sophia in Rotterdam.
Intervention
The PPI group will receive omeprazole, 40mg, once daily. The non-PPI group will
receive no medication. In both groups, blood will be drawn at several time
points, until delivery.
Study burden and risks
This study evaluates the effect of PPI use in patients with preeclampsia on
sFlt-1 levels. A potential benefit of participation in this study is that
lowering of sFlt-1, mitigates the severity of PE, leading to a prolongation of
days until delivery. A potential burden of participation in this study is that
in both groups, blood is drawn repeatedly. Furthermore, in the PPI group,
patients need to take (additional) daily medication.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Women (>=18 years) with a singleton pregnancy diagnosed with PE with a
gestational age between >= 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
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2018-000283-28-NL |
| CCMO | NL64821.078.18 |