The PreRisk calculator in suspected or confirmed preeclampsia: A new tool to safely reduce the number of unnecessary admissions’

Recruiting

Conditions: <p>Preeclampsia</p>

Registration Number: NL-OMON22891

Lead Sponsor: one

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 864

Inclusion Criteria

• Women with a singleton pregnancy
• Age = 18 years
• Gestational age = 20 weeks and <37 weeks
• Suspected or confirmed PE
• Alive fetus without fetal distress requiring immediate delivery

Exclusion Criteria

- Other reasons than (suspected) PE requiring hospitalization.
- The presence of partial (HELLP) syndrome at time of inclusion.
- The presence of fetal death at time of inclusion.
- Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities
- Unable to provide written informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Composite outcome of PE-related complications in both study arms: a. maternal complications defined as: acute renal failure, cerebral haemorrhage/oedema or infarction, death, eclampsia, development of the (partial) HELLP syndrome, pulmonary oedema, subcapsular liver hematoma, placental abruption, serious visual disturbances and b. fetal complications defined as: fetal death and fetal distress requiring immediate delivery 2) Number and total duration of admissions.</p>

Secondary Outcome Measures

Name	Time	Method
<p>- 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.</p>