Organ impairment in preeclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Women are included at the time of diagnosis of preeclampsia or at the corresponding gestational age for women with normotensive pregnancies. At inclusion, blood samples are drawn and women are asked t
Sponsors
Sahlgrenska University Hospital
Uppsala University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Preeclampsia cohort: 1. Primiparous and parous pregnant women 2. Aged =18 years 3. Diagnosis of preeclampsia after gestational week 20 Control cohort: 1. Primiparous and parous women 2. Aged =18 years 3. Healthy pregnancies matched for gestational age
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 10/01/2022: 1. Unable to give written informed consent 2. Magnetic resonance imaging (MRI) contraindications, including claustrophobia, for MR group only 3. Diabetes Mellitus before or during pregnancy, pre-existing cardiovascular, renal, or cerebral disease, or pre-existing hypertension for special investigations including MRI, echocardiography, cerebral doppler measurements, and cognitive function assessment Previous participant exclusion criteria: 1. Unable to give written informed consent 2. Pre-existing hypertension 3. Diabetes Mellitus before or during pregnancy 4. Pre-existing cardiovascular, renal, or cerebral disease 5. Magnetic resonance imaging (MRI) contraindications, including claustrophobia, for MR group only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 11/09/2024: Organ dysfunction is measured using the following at inclusion in the study and after delivery: 1. Cognitive function is measured by magnetic resonance imaging (resting state) and a series of validated objective tests such as WAIS, SRB1, and Deary test, and, in addition, a subjective test called cognitive failure questionnaire 2. Cerebral blood flow regulation is measured by the Doppler technique and magnetic resonance imaging 3. Cerebral biomarkers are measured in cerebrospinal fluid and plasma by ELISA and SIMOA technique 4. Cardiac biomarkers are measured in plasma by automated laboratory-based instruments used in clinical care. 5. Coagulation is measured by thrombelastogram - ROTEM and Multiplate 6. Cardiac function is measured by transthoracic echocardiography 7. Cardiovascular indicators in women with preeclampsia and normotensive pregnancies at time of inclusion, at three and 12 months after birth 8. Complications related to preeclampsia at the time of enrolment, before delivery and before discharge from the hospital. Previous primary outcome measures: Organ dysfunction is measured using the following at inclusion in the study and after delivery: 1. Cognitive function is measured by magnetic resonance imaging (resting state) and a series of validated objective tests such as WAIS, SRB1, and Deary test, and, in addition, a subjective test called cognitive failure questionnaire 2. Cerebral blood flow regulation is measured by doppler technique and magnetic resonance imaging 3. Cerebral biomarkers are measured in cerebrospinal fluid and plasma by ELISA and SIMOA technique 4. Cardiac biomarkers are measured in plasma by automated laboratory based instruments used in clinical care. 5. Coagulation is measured by thrombelastogram - ROTEM and Multiplate 6. Cardiac function is measured by transthoracic echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/01/2021: 1. Patient reported outcomes are measured by General Self-Efficacy scale, (GES) Hospital Anxiety and Depression Scale, (HADS), Edinburgh Postnatal Depression Scale, (EPDS) EuroQol—5 Dimensions (EQ-5D), EuroQol- Visual Analogue Scale (EQ-VAS), Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) at diagnosis of preeclampsia and compared with healthy controls. The GES, HADS, EPDS, EQ-5D, EQ-VAS, Childbirth experience questionnaire,2 (CEC2), PCL-5 and the Breastfeeding self-efficacy scale short form (BSE) are re-evaluated 8-12 weeks after birth. The GES, HADS, EPDS, EQ-5D, EQ-VAS, CEQ2, PCL-5 and BES are again re-evaluated 1 year after birth. 2. Qualitative interviews will be performed six months after birth. The aims of the qualitative research in the project are to describe the women's and their partner’s lifeworld experiences of severe preeclampsia during pregnancy, childbirth and postnatal care. The target number of participants for the qualitative study are 15 to 20 women and partners. Open-ended questions will be used to collect the data. The women will be asked to describe their experiences of severe preeclampsia during pregnancy, childbirth and postnatal care. The interviews will last about 60 minutes and will be audio-recorded. All interviews will be transcribed verbatim. The data will be analyzed using thematic or phenomenological analysis. _____ Previous secondary outcome measures: Patient reported outcomes are measured by General Self-Efficacy scale, Hospital Anxiety and Depression Scale, Edinburgh Postnatal Depression Scale, E-Q-5D visual analogue scale, Post Traumatic Stress Disorder Checklist for DSM-5, Childbirth experience questionnaire, and the Breastfeeding self-efficacy scale short form after delivery | — |
Countries
Sweden
Outcome results
None listed