Core Outcome Measures in Effectiveness Trials

Core outcome sets for immunomodulation in pregnancy

General Information

Summary:
Several if not most complications of pregnancy are partly caused by immune maladaptation. Immunomodulation has been used for several indications to improve pregnancy outcome. This immune modulating therapies will improve and be more targeted in the next few years as several initiatives are used to develop targeted save immunotherapy in pregnancy. In current literature many different outcomes are reported, which hampers proper comparison of data. We want to come to a core outcome set for immunomodulation in pregnancy and use the existing core outcome sets for the conditions necessitating therapy such as preterm birth (developed COS) and fetal growth restriction (in development).

Contributors:
J.R. Prins, University Medical Center Groningen, the Netherlands
S.A. Robertson, Robinson Institute, University of Adelaide, Australia
S.J. Gordijn, University Medical Center Groningen, the Netherlands

Further Study Information

Current Stage:
Ongoing
Date:
July 2017 - July 2018
Funding source(s):
None

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Fetal/foetal growth restriction (FGR)
Miscarriage
Pre-eclampsia
Pregnancy complications
Preterm birth

Target Population

Age Range
18 - 60

Sex
Female


Nature / type of Intervention
Immunotherapy

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Literature review
Systematic review

Firstly, literature will be reviewed for already in use outcomes after immune modulation in pregnancy. There-after a DELPHI process will be initialised to obtain expert consensus about which outcomes are the core outcomes.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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