O14
Conditions
Interventions
Group 1: Intervention group:
Pregnant women at increased risk of preeclampsia will receive care from 24+0 weeks of gestation onwards using a digital, algorithm-based clinical decision support tool and
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
Female
Age
18 Years to 44 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Pregnant women between 24+0 and 36+0 weeks of gestation. 2. Increased risk of preeclampsia, defined as one of the following: a. Chronic hypertension, with or without antihypertensive medication; or b. Gestational hypertension, with or without antihypertensive medication (newly diagnosed or previously established); or c. Clinical suspicion of preeclampsia, defined by the presence of one or more of the following: i. Hypertension: systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg (newly diagnosed or previously established); and/or ii. Proteinuria: =300 mg/24 hours; and/or a protein-to-creatinine ratio (PCR) =30 mg/mmol (equivalent to =300 mg/g or =0.3 g/g); and/or iii. Symptoms suggestive of preeclampsia: Visual disturbances (e.g., flashing lights or blurred vision); and/or epigastric pain or pain in the right upper quadrant of the abdomen; and/or headache; and/or iv. Edema involving the hands, feet, or face. 3. Singleton pregnancy. 4. Ability to provide informed consent. 5. Age =18 years and <45 years. 6. Covered by statutory health insurance in Germany. 7. Residence in Germany. 8. Written informed consent obtained prior to study participation. 9. Access to a smartphone.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Blood pressure =160/110 mmHg, if either of the blood pressure measurements obtained at the screening visit exceeds this threshold. 2. Elevated sFlt-1/PlGF ratio: a. For women up to 33+6 weeks of gestation: sFlt-1/PlGF ratio =200. b. For women from 34+0 weeks of gestation onward: sFlt-1/PlGF ratio =110. 3. Severe preeclampsia according to the American College of Obstetricians and Gynecologists (ACOG) criteria (see Appendix, Table A1). 4. Any serious maternal or fetal condition requiring inpatient hospital treatment. 5. Clinically manifest HELLP syndrome. 6. Pre-existing medical conditions that would impair the participant's ability to understand the study procedures or comply with the study protocol. 7. Insufficient proficiency in the German language. 8. Current participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the use of the PreFree system with respect to its superiority over the control group (standard care) based on the following co-primary endpoints: Number of days pregnant and out of hospital due to preeclampsia from study enrolment until delivery. Occurrence of at least one preeclampsia-associated complication (maternal and/or fetal/neonatal) in the mother up to 42 days postpartum or in the infant up to 28 days after birth. Outcome measures will be collected throughout the entire study period and will be assessed comprehensively at the final follow-up visit, 6 weeks postpartum. An independent endpoint adjudication committee will be established to review and validate the study endpoints. Questionnaires (including the EQ-5D Visual Analogue Scale [EQ-5D VAS], Generalized Anxiety Disorder-7 [GAD-7], and Client Satisfaction Questionnaire [ZUF-8]) Statutory health insurance claims data Clinical examinations Medical documentation in the patient's medical record App usage data | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints are: • Number of days pregnant and out of hospital due to preeclampsia during the study period (from study enrolment until the 6-week postpartum follow-up). • Number of preeclampsia-related hospital days (from study enrolment until delivery). • Number of all outpatient healthcare encounters (including preeclampsia-related visits) and days of sick leave (from study enrolment until delivery). • Time interval from the indication for induction of labour or spontaneous onset of labour to delivery. • Timing of labour induction. • Safety (from study enrolment until the 6-week postpartum follow-up). • Health-related quality of life (from study enrolment until the 6-week postpartum follow-up). • Patient satisfaction (from study enrolment until the 6-week postpartum follow-up). • Healthcare costs up to delivery from the statutory health insurance perspective (from study enrolment until the 6-week postpartum follow-up). • Adherence to home monitoring. | — |
Countries
Germany
Contacts
Public ContactJoena Bunke
Universitätsklinikum Hamburg Eppendorf
Outcome results
None listed