A study for investigating organ complications in preeclampsia
| ISRCTN | ISRCTN10623443 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10623443 |
- Submission date
- 10/06/2020
- Registration date
- 16/07/2020
- Last edited
- 18/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Pre-eclampsia, one of the most serious complications of pregnancy, is associated with severe morbidity and mortality for the mother and baby. There is an urgent need to better understand this devastating disease.
Pre-eclampsia affects 3-8 % of pregnancies worldwide. It is a multi-system disorder involving maternal blood vessels, the kidneys, the liver, the lungs, and the fetus. In its most severe form, it affects the brain, causing seizures (eclampsia), cerebrovascular events and even death. It is a leading cause of maternal and fetal/neonatal morbidity.
Globally, pre-eclampsia is responsible for > 60,000 maternal deaths annually, and in South Africa the hypertensive disorders of pregnancy are responsible for 14% of maternal deaths. The pathophysiology of pre-eclampsia is not completely understood but the leading hypothesis is based on placental dysfunction.
Unfortunately, pre-eclampsia is a disease that is seen only in humans and there are no convincing animal models of pre-eclampsia. This makes it imperative that critical laboratory observations are made on human tissues.
Study aims
We propose establishing an ethically responsible biobank to facilitate quicker access to clinical information, special investigations and biological samples to undertake research in the field of pre-eclampsia. It is modelled on many tissue banks currently in existence.
Who can participate?
Women with pre-eclampsia (cases) and women with healthy pregnancies (controls) between the ages of 16-45 and in gestational week 20-42 will be eligible. As this is a biobank there will be no limit to the number of participants included.
What does the study involve?
Our research team will be notified by attending clinicians when there is a possible candidate for the biobank. A member of the research team will then see the candidate and will give them an information and consent sheet and explain the project. If they decide to participate and after consent has been obtained, clinical information will be collected, samples may be collected, and special investigations may be done. The participants will be seen daily and will be contacted again after discharge. All information will be kept confidential and the participants may withdraw at any stage.
Possible risks and benefits of participating
The risk of adverse events is unlikely. There are no added risks associated with being involved in the study. Any publications arising from projects that utilised the biobank will need to acknowledge the participants.
All information collected will be stored in a locked office in the principal researcher or research midwife's office. The medical data will be recorded in a REDCap database and only the biobank investigators and research midwives will have access to the identification codes. All information used for follow-up projects will be pseudonymised. Samples stored in the biobank will be given an identifying code and will not contain any identifying information.
Samples will not be used for a genetic register.
Where is the study run from?
The study is run from Tygerberg Hospital, Cape Town, South Africa
When is the study starting and how long is it expected to run for?
The study started in April 2018 and is expected to run until December 2030
Who is funding the study?
This study is supported by STINT; The Swedish foundation of International Cooperation in Research and Higher Education, Preeclampsia foundation, Märta Lundqvist’s foundation, Ester Åsberg’s foundation, Jane and Dan Olsson’s foundation, Center for Clinical research Dalarna and the Swedish Society of Medicine.
Who is the main contact?
Dr Catherine Cluver, cathycluver@hotmail.com
Dr Lina Bergman, lina.bergman.2@gu.se
Contact information
Scientific
Department of Obstetrics and Gynaecology
Faculty of Health Sciences
Stellenbosch University
Francie van Zyl Drive
Tygerberg
Cape Town
7505
South Africa
 ORCID ID |
0000-0002-0406-8964 |
|---|---|
| Phone | +27 823210298 |
| cathycluver@hotmail.com |
Public
Sankt Sigfridsgatan 46
Gothenburg
41266
Sweden
| ORCID ID |
0000-0001-5202-9428 |
|---|---|
| Phone | +46 707920780 |
| lina.bergman.2@gu.se |
Study information
| Study design | Single center prospectively collected database and biobank of women with severe preeclampsia |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | PROVE: PReeclampsia Obstetric adVerse Events |
| Study acronym | PROVE |
| Study objectives | To set up a preeclampsia biobank at Tygerberg Hospital, Stellenbosch University, to facilitate clinical and laboratory based research in preeclampsia. |
| Ethics approval(s) | Approved 28/02/2018, Regional ethical board at Stellenbosch University (PO Box 241, Cape Town 8000, South Africa; +27 (0)21 9389677; no email provided), ref: N17/05/048 |
| Health condition(s) or problem(s) studied | Preeclampsia |
| Intervention | Our research team will be notified by attending clinicians when there is a possible candidate for the biobank. A member of the research team will then see the candidate and will give them an information and consent sheet and explain the project. If they decide to participate and after consent has been obtained, clinical information will be collected, samples may be collected, and special investigations may be done. The participants will be seen daily and will be contacted again after discharge. All information will be kept confidential and the participants may withdraw at any stage. When a project arises that involves the use of information or samples from the biobank, an independent proposal to HREC will be obtained and approval from the Preeclampsia biobank will be requested. Once this is done, deidentified information and samples will be released. The outcomes of updates will be reported annually to the ethics committee. We will collect information on the pregnancy and outcomes of the pregnancy. We may perform cognitive function assessments and questionaries on symptoms and signs of preeclampsia. Special investigations could include MRI examinations of the brain, studies using ultrasound, ophthalmological examinations and non-invasive endothelial function assessment. The sample collection includes the following • 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. • 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. • Saliva: This will be collected once in a 3 cc cup, 1-2 ml for freezing. |
| Intervention type | Other |
| Primary outcome measure | The items collected for the biobank include: 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 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 3. Saliva: This will be collected once in a 3 cc cup, 1-2 ml for freezing |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2017 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Female |
| Target number of participants | 100 women with eclampsia, 100 women with pulmonary edema, 50 women with preeclampsia without end organ complications and 50 women with normal pregnancies |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/04/2018 |
| Date of final enrolment | 31/12/2029 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Francie van Zijl Drive
Cape Town
7505
South Africa
Sponsor information
University/education
Faculty of MEdicine and Health Sciences
Francie van Zyl Drive
Tygerberg
Cape Town
7505
South Africa
| Phone | +27 21 938 9111 |
|---|---|
| cathycluver@hotmail.com | |
| Website | http://www.sun.ac.za/english/faculty/healthsciences |
"ROR" |
https://ror.org/05bk57929 |
Funders
Funder type
Hospital/treatment centre
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Swedish Society of Medicine, Swedish Medical Society, SLS
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Märta Lundqvists Foundation
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Stiftelsen för internationalisering av högre utbildning och forskning, STINT
- Location
- Sweden
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Preeclampsia Foundation, Preeclampsia Fndn, PF
- Location
- United States of America
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Jane and Dan Olssons Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in high impact peer reviewed journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | case control study | 17/03/2021 | 22/10/2021 | Yes | No |
| Other publications | observational study of blood pressure as a risk factor for eclampsia | 23/07/2021 | 22/10/2021 | Yes | No |
| Other publications | observational study of cognitive impairment in preeclampsia | 16/02/2021 | 22/10/2021 | Yes | No |
| Protocol article | protocol | 20/04/2021 | 22/10/2021 | Yes | No |
| Other publications | Associations Between Soluble fms-Like Tyrosine Kinase-1 and Placental Growth Factor and Disease Severity Among Women With Preterm Eclampsia and Preeclampsia | 16/08/2022 | 02/11/2023 | Yes | No |
| Other publications | Cardiac magnetic resonance imaging in preeclampsia complicated by pulmonary edema shows myocardial edema with normal left ventricular systolic function | 01/08/2022 | 02/11/2023 | Yes | No |
| Other publications | Cerebral biomarkers in neurologic complications of preeclampsia | 01/08/2022 | 02/11/2023 | Yes | No |
| Other publications | Circulating Chemerin Is Elevated in Women With Preeclampsia | 13/03/2023 | 02/11/2023 | Yes | No |
| Other publications | Circulating Growth Differentiation Factor 15 Is Increased Preceding Preeclampsia Diagnosis: Implications as a Disease Biomarker | 17/08/2021 | 02/11/2023 | Yes | No |
| Other publications | Circulating concentrations of glycocalyx degradation products in preeclampsia | 13/10/2022 | 02/11/2023 | Yes | No |
| Other publications | Correlation between cognitive assessment scores and circulating cerebral biomarkers in women with pre-eclampsia and eclampsia | 01/03/2023 | 02/11/2023 | Yes | No |
| Other publications | Evidence of Neuroinflammation and Blood-Brain Barrier Disruption in Women with Preeclampsia and Eclampsia | 05/11/2021 | 02/11/2023 | Yes | No |
| Other publications | PSG7 and 9 (Pregnancy-Specific β-1 Glycoproteins 7 and 9): Novel Biomarkers for Preeclampsia | 05/04/2022 | 02/11/2023 | Yes | No |
Editorial Notes
18/07/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/07/2024 to 31/12/2029.
2. The overall study end date was changed from 01/07/2025 to 31/12/2030.
3. The intention to publish date was changed from 01/07/2024 to 31/12/2031.
02/11/2023: Publication references added.
22/10/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/07/2022 to 01/07/2024.
2. The overall trial end date has been changed from 01/07/2023 to 01/07/2025 and the plain English summary has been updated accordingly.
3. Publication references added.
11/06/2020: Trial’s existence confirmed by Stellenbosch University.
