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A study for investigating organ complications in preeclampsia

PROVE: PReeclampsia Obstetric adVerse Events

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10623443
Enrollment
300
Registered
2020-07-16
Start date
2018-04-12
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia Pregnancy and Childbirth Preeclampsia

Interventions

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 informati

Sponsors

Stellenbosch University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
There are no secondary outcome measures

Countries

South Africa

Contacts

Public ContactLina Bergman
lina.bergman.2@gu.se+46 707920780

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026