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).
Protocol: https://bmjopen.bmj.com/content/8/8/e021619
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
Disease Category: Pregnancy & childbirth
Disease Name: Pregnancy complications, Miscarriage, Pre-eclampsia, Preterm birth , Fetal/foetal growth restriction (FGR)
Age Range: 18 - 60
Sex: Female
Nature of Intervention: Immunotherapy
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- 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.