Rhekiss (Rheuma - Kinderwunsch und Schwangerschaft)

Overview
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Rhekiss is a nationwide register to record the course of disease in patients with inflammatory rheumatic diseases who wish to have children and are pregnant. Since 2015, in collaboration with the Rheumazentrum Rhein-Ruhr e. V., we have been prospectively collecting data on the course and outcome of the pregnancy and the development of the child up to its second birthday. The inflammatory rheumatic diseases covered by Rhekiss include rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, other connective tissue diseases, vasculitis and autoinflammatory syndromes. Data is collected regularly from both, rheumatologists and patients. The results will help to improve the counselling and management of women with rheumatic diseases who wish to have children, during pregnancy and when lactating.

Programme: Programme Area 2 - Epidemiology and Health Services Research

SEEK ID: https://ldh.drfz.imise.uni-leipzig.de/projects/3

Public web page: https://rhekiss.de/

NFDI4Health PALs: No PALs for this Project

Project created: 20th Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Rhekiss: Rheuma - Kinderwunsch und Schwangerschaft
Language of the title/name : German

Acronym(s) of the Project

Acronym : Rhekiss
Language of the acronym : German

Description(s) of the Project

Description : Rhekiss is a nationwide register to record the course of disease in patients with inflammatory rheumatic diseases who wish to have children and are pregnant. Since 2015, in collaboration with the Rheumazentrum Rhein-Ruhr e. V., we have been prospectively collecting data on the course and outcome of the pregnancy and the development of the child up to its second birthday. The inflammatory rheumatic diseases covered by Rhekiss include rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, other connective tissue diseases, vasculitis and autoinflammatory syndromes. Data is collected regularly from both, rheumatologists and patients. The results will help to improve the counselling and management of women with rheumatic diseases who wish to have children, during pregnancy and when lactating. Rhekiss collaborates with other European pregnancy registers within the European Network of Pregnancy Registers in Rheumatology (EuNeP).
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Inflammatory rheumatic diseases

Keyword(*) : Pregnancy

Keyword(*) : Lactation

Keyword(*) : Cohort study

Language(s) of the project : German

Web page of the project : https://rhekiss.de/

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Anja
Family name(s)(*) : Strangfeld
Digital identifier(s)
Identifier(*) : 0000-0002-6233-022X
Scheme(*) : ORCID
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : strangfeld@drfz.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : German Rheumatology Research Center
Address : Charitéplatz 1, 10117 Berlin
Web page : https://www.drfz.de/forschung/programmbereich-2/
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Project leader
Given name(*) : Yvette
Family name(s)(*) : Meißner
Digital identifier(s)
Identifier(*) : 0000-0003-0147-4112
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : y.meissner@drfz.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00024215

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Cohort, Longitudinal
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Rheumatoide Arthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M05
Primary health condition or disease name(*) : Rheumatoide Arthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M06
Primary health condition or disease name(*) : Psoriasisarthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M07.0
Primary health condition or disease name(*) : Psoriasisarthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M07.1
Primary health condition or disease name(*) : Psoriasisarthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M07.2
Primary health condition or disease name(*) : Psoriasisarthritis
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M07.3
Primary health condition or disease name(*) : Spondyloarthritiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M45
Primary health condition or disease name(*) : Spondyloarthritiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M46
Primary health condition or disease name(*) : Juvenile idiopathische Arthritiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M08
Primary health condition or disease name(*) : Systemischer Lupus erythematodes
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M32.1
Primary health condition or disease name(*) : Systemischer Lupus erythematodes
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M32.8
Primary health condition or disease name(*) : Systemischer Lupus erythematodes
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M32.9
Primary health condition or disease name(*) : andere Kollagenosen
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M33
Primary health condition or disease name(*) : andere Kollagenosen
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M34
Primary health condition or disease name(*) : andere Kollagenosen
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.0
Primary health condition or disease name(*) : andere Kollagenosen
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.1
Primary health condition or disease name(*) : andere Kollagenosen
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.4
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.3
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.4
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.5
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.6
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M30
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.7
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.3
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M31.1
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.2
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : D89.1
Primary health condition or disease name(*) : Vaskulitiden
Terminology/classification(*) : ICD-10
Code of the health condition or disease : D68.6
Primary health condition or disease name(*) : Autoinflammatorische Syndrome
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M35.8
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Pregnancy, childbirth or the puerperium (XV), Certain conditions originating in the perinatal period (XVI), Congenital malformations, deformations and chromosomal abnormalities (XVII)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, vital status only (cause of death missing)
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (II): Recruitment and data collection ongoing
Participants enrolled by invitation? : Not applicable
Start date : 1 September 2015
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : 125
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Female
Inclusion criteria : at least 18 years of age, inflammatory rheumatic disease (rheumatoid arthritis or spondyloarthritis or psoriatic arthritis or juvenile idiopathic arthritis or systemic lupus erythematosus or other connective tissue disease or vasculitis or autoinflammatory syndrome), patient wants to conceive or is currently pregnant (until gestational week 20)
Exclusion criteria : None
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Nationwide
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : anti-rheumatic drugs
Type of the exposure : Drug (including placebo)
Additional information about the exposure : Any approved drug for the treatment of inflammatory rheumatic diseases
Name(s) of the group(s) associated with the given exposure : conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD); biologic disease-modifying anti-rheumatic drugs (bDMARD); targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD), corticosteroids, non-steroidal anti-inflammatory drugs (NSAID)
Outcome measures in the Project
Name of the outcome measure(*) : Adverse pregnancy and neonatal outcomes
Description of the outcome measure : abortion, stillbirth, live birth, preterm birth, thromboembolic events, gestational diabetes, hypertensive disrders of pregnancy, maternal and infant infections, small for gestational age, malformations
Type of the outcome measure : Primary
Time point(s) of assessment : every pregnancy trimester; 3 months postpartum
Name of the outcome measure(*) : Course of the rheumatic disease before, during and after pregnancy
Description of the outcome measure : Different disease activity instruments, depending on the rheumatic diseases; Inflammation; Patient reported outcomes; Flares
Type of the outcome measure : Primary
Time point(s) of assessment : Every 6 months prior to conception; every pregnancy trimester; 3, 6, 12, 18 and 24 months postpartum
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : Tobacco use, Body weight, Body height, Body Mass Index, Sociodemographic information
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : 10 years after termination of the project
Criteria for data access : There is no standardized routine to access the data.
Additional information about data sharing : Rhekiss is collaborating with other European pregnancy registers in rheumatology and with other national registers in order to perform joint data analyses. The scientific advisory board may be approached via the PIs to suggest research questions or collaborations.
DataSHIELD/Opal infrastructure available? : No
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 5
Unit of time(*) : Years
Number of follow-ups conducted : 13
Biosamples retained in a biorepository : None retained
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

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Rhekiss (Rheuma - Kinderwunsch und Schwangerschaft)

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