Toxemia of pregnancy
Conditions
Interventions
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 gy
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women (>=18 years) with (suspected) PE with a singleton pregnancy and a gestational age of >= 20 weeks and =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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Difference in PE-related (maternal/fetal) complications between the intervention group and control group. 2) Number and total duration of admissions. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed