The effect of gastric reflux medication on biomarkers in toxemia of pregnancy

Phase 1

• Conditions: Angiogenic markers in preeclampsia; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-000283-28-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-03
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 44

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
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)<br>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.<br>3. Blood pressure regulation and the need for blood pressure medication between PPI group and non-PPI group.<br>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.