A study for investigating organ complications in preeclampsia

Not Applicable

• Conditions: Preeclampsia; Pregnancy and Childbirth

• Registration Number: ISRCTN10623443
• Lead Sponsor: Stellenbosch University

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33744176/ case control study (added 22/10/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34392166/ observational study of blood pressure as a risk factor for eclampsia (added 22/10/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33492667/ observational study of cognitive impairment in preeclampsia (added 22/10/2021) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33924230/ protocol (added 22/10/2021) 2022 Other publications in https://doi.org/10.1161/jaha.121.024395 Associations Between Soluble fms-Like Tyrosine Kinase-1 and Placental Growth Factor and Disease Severity Among Women With Preterm Eclampsia and Preeclampsia (added 02/11/2023) 2022 Other publications in https://doi.org/10.1016/j.ajog.2022.03.009 Cardiac magnetic resonance imaging in preeclampsia complicated by pulmonary edema shows myocardial edema with normal left ventricular systolic function (added 02/11/2023) 2022 Other publications in https://doi.org/10.1016/j.ajog.2022.02.036 Cerebral biomarkers in neurologic complications of preeclampsia (added 02/11/2023) 2023 Other publications in https://doi.org/10.1210/endocr/bqad041 Circulating Chemerin Is Elevated in Women With Preeclampsia (added 02/11/2023) 2021 Other publications in https://doi.org/10.1161/jaha.120.020302 Circulating Growth Differentiation Factor 15 Is Increased Preceding Preeclampsia Diagnosis: Implications as a Disease Biomarker (added 02/11/2023) 2022 Other publications in https://doi.org/10.3389/fphys.2022.1022770 Circulating concentrations of glycocalyx degradation products in preeclampsia (added 02/11/2023) 2023 Other publications in https://doi.org/10.1016/j.preghy.2022.12.001 Correlation between cognitive assessment scores and circulating cerebral biomarkers in women with pre-eclampsia and eclampsia (added 02/11/2023) 2021 Other publications in https://doi.org/10.3390/cells10113045 Evidence of Neuroinflammation and Blood-Brain Barrier Disruption in Women with Preeclampsia and Eclampsia (added 02/11/2023) 2022 Other publications in https://doi.org/10.1161/jaha.121.024536 PSG7 and 9 (Pregnancy-Specific ß-1 Glycoproteins 7 and 9): Novel Biomarkers for Preeclampsia (added 02/11/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Last Update Posted: 29 July 2024
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Cases:
1.1. Women with a diagnosis of preeclampsia or severe preeclampsia in gestational week 20-42
1.2. Admitted to Tygerberg hospital
Severe preeclampsia is defined as preeclampsia with an organ complication such as renal failure, pulmonary oedema, eclampsia, intracerebral hemorrhage, cerebral oedema, heart failure or disseminated intravascular coagulation

2. Controls:
2.1. Women with healthy pregnancies matched for gestational age admitted for delivery at Tygerberg hospital

Both primiparous and parous women are included

Exclusion Criteria

1. Cases: If the woman is not able to give informed consent
1.1. For women with pulmonary edema: Existing cardiac disease
1.2. For women with eclampsia: Existing neurological disease
2. Normotensive controls:
2.1. Pre-exisiting hypertension
2.2. Diabetes mellitus before or during pregnancy
2.3. Pre-exisiting cardiovascular, renal or cerebral disease
2.4. Chronic medication

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The items collected for the biobank include:<br>1. Specimens usually discarded during clinical care: E.g. placenta, placental membranes, umbilical cord, cord blood, urine, stool and cerebrospinal fluid (CSF). The CSF (maximum volume of 0.5 ml) will only be collected in women who are having spinal anaesthesia. We will collect the fluid that is usually discarded before the anaesthetic is injected<br>2. Blood samples: maximum of 12 ml at each collection time (usually only a single test tube of 5 ml). We will only collect samples if the patient is having blood taken for a clinical indication. We will collect blood up to a maximum of 6 times per participant<br>3. Saliva: This will be collected once in a 3 cc cup, 1-2 ml for freezing

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures