Condition category
Pregnancy and Childbirth
Date applied
10/06/2020
Date assigned
16/07/2020
Last edited
16/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 July 2022.

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

Trial website

http://www.preeclampsiaresearch.com

Contact information

Type

Scientific

Primary contact

Prof Catherine Cluver

ORCID ID

https://orcid.org/0000-0002-0406-8964

Contact details

Department of Obstetrics and Gynaecology
Faculty of Health Sciences
Stellenbosch University
Francie van Zyl Drive
Tygerberg
Cape Town
7505
South Africa
+27 823210298
cathycluver@hotmail.com

Type

Public

Additional contact

Dr Lina Bergman

ORCID ID

http://orcid.org/0000-0001-5202-9428

Contact details

Sankt Sigfridsgatan 46
Gothenburg
41266
Sweden
+46 707920780
lina.bergman.2@gu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

PROVE: PReeclampsia Obstetric adVerse Events

Acronym

PROVE

Study hypothesis

To set up a preeclampsia biobank at Tygerberg Hospital, Stellenbosch University, to facilitate clinical and laboratory based research in preeclampsia.

Ethics approval

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

Study design

Single center prospectively collected database and biobank of women with severe preeclampsia

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/07/2017

Overall trial end date

01/07/2023

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

All

Gender

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

Participant 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

Recruitment start date

12/04/2018

Recruitment end date

01/07/2022

Locations

Countries of recruitment

South Africa

Trial participating centre

Tygerberg Hospital
Stellenbosch University Francie van Zijl Drive
Cape Town
7505
South Africa

Sponsor information

Organisation

Stellenbosch University

Sponsor details

Faculty of MEdicine and Health Sciences
Francie van Zyl Drive
Tygerberg
Cape Town
7505
South Africa
+27 21 938 9111
cathycluver@hotmail.com

Sponsor type

University/education

Website

http://www.sun.ac.za/english/faculty/healthsciences

Funders

Funder type

Hospital/treatment centre

Funder name

Mercy Perinatal

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Svenska Läkaresällskapet

Alternative name(s)

Swedish Society of Medicine, Swedish Medical Society, SLS

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Sweden

Funder name

Märta Lundqvists Stiftelse

Alternative name(s)

Märta Lundqvists Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Sweden

Funder name

Swedish Foundation for International Cooperation in Research and Higher Education

Alternative name(s)

Stiftelsen för internationalisering av högre utbildning och forskning, STINT

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Sweden

Funder name

Preeclampsia Foundation

Alternative name(s)

Preeclampsia Foundation, Inc., The Preeclampsia Foundation, PF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Funder name

Ester Åsbergs Stiftelse

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Center for Clinical research, Dalarna, Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Jane och Dan Olssons Stiftelse

Alternative name(s)

Jane and Dan Olssons Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publications in high impact peer reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/07/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/06/2020: Trial’s existence confirmed by Stellenbosch University.