The objective of our study is to investigate whether application of the PreRisk calculator, based on the sFlt1/PlGF ratio,protein-to-creatinine ratio and gestational age, in patients with (suspected) PE can reduce the number and duration of…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Difference in PE-related (maternal/fetal) complications between the
intervention group and control group.
2) Number and total duration of admissions.
Secondary outcome
Secondary outcomes:
- Number of outpatient clinic visits.
- Societal costs (health care and non-health care costs).
- Impact on psychological issues will be assessed by measuring anxiety with the
State-Trait Anxiety Inventory (STAI)
questionnaire. Questionnaires will be provided to women (and their partners)
whom have entered the trial at baseline, 1 week
after inclusion, and 1 week after delivery. Furthermore, qualitative interviews
in a subset of women and their partners will be
held.
- Neonatal complications (defined as: preterm delivery, admission to neonatal
intensive care, artificial ventilation,bronchopulmonary dysplasia, infant
respiratory distress syndrome, necrotizing enterocolitis, small-for-gestational
age, cerebral bleeding/palsy and neonatal death)(13).
- Gestational age at delivery, prolongation of pregnancy duration since
inclusion.
- Method of delivery and number of induced deliveries.
- Acceptability: Physician*s appreciation of the use of the risk calculator
(PreRisk questionnaire twice a year). Qualitative
interviews in a subset of physicians.
Background summary
Preeclampsia (PE) is a syndrome most commonly defined as new onset hypertension
and proteinuria at gestational week 20 or after, but the use of these variables
to predict the course of PE and the development of adverse maternal and
fetal/neonatal outcomes is not reliable. For reasons of safety, common practice
today is that all patients suspected of PE are hospitalized for clinical and
laboratory evaluation. A significant amount of research has been done on the
ability of the sFlt-1/PlGF ratio to predict the absence or presence of PE or
pregnancy-related complications and cutoff values to rule out or rule in PE or
its course, have been provided. Recently, we reported from data of the PreRatio
population that these predictions could be significantly improved by using
continuous instead of dichotomous values of the biomarkers or their ratio and
based on this knowledge, using multivariate regression analysis, we developed a
risk-calculator (The PreRisk calculator) that includes the sFlt-1/PlGF ratio,
gestational age and protein-to-creatinine ratio (manuscript in preparation). We
hypothesize that the PreRisk calculator will help gynecologists better predict
which patients are at high risk of serious maternal, fetal and neonatal
preeclampsia-related complications and should be admitted to the obstretic ward
and which patients can continue monitoring at home.
Study objective
The objective of our study is to investigate whether application of the PreRisk
calculator, based on the sFlt1/PlGF ratio,
protein-to-creatinine ratio and gestational age, in patients with (suspected)
PE can reduce the number and duration of hospital
admissions leading to a reduction of costs, without compromising maternal and
fetal health.
Study design
Prospective, randomized, multicenter intervention study.
Intervention
Women with suspected or confirmed PE will be randomized into two groups:
- The usual care group will receive no intervention. This means that the
management of these patients will be based on the gynaecologist*s clinical and
on laboratory assessment. Blood samples will be collected weekly for the
sFlt-1/PlGF ratio and risk calculation, which will be determined after the
study.
- In the intervention group the serum biomarkers sFlt-1 and PlGF in addition to
routine clinical and laboratory assessment will be determined at weekly
intervals and with the use of the PreRisk calculator the chance of
maternal/neonatal complications are calculated. As agreed with the
gynecologists of the project group, patients with a score <5% do not require
hospitalization and can be followed biweekly at the outpatient clinic.
Study burden and risks
The potential risks associated with the intervention group will be only for the
patients who are sent home based on the PreRisk calculator. Although our
hypothesis suggests that the PreRisk calculator could calculate which patients
have a low risk of complications correctly, there is still a chance these
patients could develop complications at home. To minimize this, these patients
are seen once to twice weekly at the outpatient clinic, and the risk will be
calculated weekly. Furthermore, gynecologists are allowed to treat a patient
according to their own findings and clinician*s expertise, and not only based
on the risk calculator.
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3000CA
NL
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3000CA
NL
Listed location countries
Age
Inclusion criteria
Women (>=18 years) with (suspected) PE with a singleton pregnancy and a
gestational age of >= 20 weeks and <37 weeks.
PE defined as de novo onset hypertension (systolic blood pressure of >=140 and
diastolic blood pressure of >=90mm Hg) and proteinuria (protein-to-creatinine
ratio >=30mg/mmol or >= 300mg/24h, or 2+ dipstick) at or after 20 weeks of
pregnancy.
Exclusion criteria
Multiple pregnancies
Not willing to give written informed consent.
Other reasons than (suspected) PE requiring hospitalization
The presence of HELLP syndrome at time of inclusion
Fetal death at time of inclusion.
Pregnancy with a fetus affected by major congenital birth defects and/or
chromosomal abnormalities
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63386.078.17 |
| OMON | NL-OMON22891 |