IMPRESS 2 Study: International Multicentric prospective study on PREgnancy in Systemic Sclerosis
Patients with systemic sclerosis who plan a pregnancy for the years 2013-16 may be interested in participating in an international observational prospective study initiated by EUSTAR on pregnancy in women with systemic sclerosis.
SSc occurs much more frequently in women than in men. The mean age at onset of symptoms is in the early 40’s. Therefore, women have the potential to become pregnant after the onset of the disease. Since very few studies have included large numbers of pregnant patients and followed them before during and after pregnancy, a number of important questions remain open and need more extensive study. Among them are:
Does pregnancy alter the course of systemic sclerosis in the short term or long term?
Are different forms systemic sclerosis differently influenced by pregnancy?
Does systemic sclerosis increase the risk of pregnancy complications?
What are the prospects of patients with renal disease, heart or lung disease to deliver a term, healthy child?
Are complications of SSc more frequent during pregnancy than in the non-pregnant state?
What is the best treatment for complications of systemic sclerosis during pregnancy?
How should systemic sclerosis be monitored during pregnancy?
To answer these important questions, a study of the course of disease both in pregnant patients and in age-matched non-pregnant patients with SSc over 2 years is necessary. As a control for the pregnant patients with SSc, healthy pregnant women must be followed during their pregnancies as well.
The study is purely observational, meaning that all relevant data are collected and then analyzed, aiming to study at least 100 pregnancies in SSc women. The study design is as follows:
Pregnant SSc patients are studied before (when possible), during, and after pregnancy. Data are collected once before pregnancy; once in the first, second, and third trimesters, more often if disease activity requires it; at delivery and then 1 year after delivery or a flare.
Non-pregnant SSc patients 20-45 years old are the controls for the pregnant SSc patients and will be matched with them for age and disease type. They also constitute a pool of SSc women who might become pregnant. They show the disease course over 2 years with complications and adjustments of therapy. This can answer the question: are disease complications more or less frequent during pregnancy?
Healthy pregnant women are studied at the same time points of pregnancy as the pregnant SSc patients. They show the physiological changes of pregnancy both in laboratory and in clinical symptoms. These can then be separated from disease related changes/events.
Duration of the study: 2 years
Storage of serum samples: At each visit serum samples may be taken from all patients and controls according to local practices. These samples are designed as markers of disease activity and disease type and will also serve for studies of new antibodies, cytokines or proteins of interest in SSc.
Importance of the study: An international project including EU and American centres will provide sufficiently large numbers of patients to study pregnancy in this rare disease. By including two control groups, comparisons can be made between SSc pregnant and healthy pregnant women, as well as between SSc pregnant and non-pregnant SSc women. The latter comparison can detect whether pregnancy has a major influence on disease activity and prognosis of SSc. In addition, the project allows discovery of whether subsets of SSc show different complications of pregnancy or of pregnancy outcome and child health. The study will help to find the best way to monitor pregnant patients with SSc, to treat arising complications during pregnancy, and to ensure a healthy pregnancy for mother and child. Furthermore, the results will improve counselling of patients with SSc who plan a pregnancy.
Publication: The results of the study will be published in Medical Journals and will also be summarised in special articles for Scleroderma Patient Associations.
Patient involvement: Women wishing to be included in the study should specify their wishes to their doctors. If the centre in which they are followed is already included in the IMPRESS network it should be easy to collect their clinical data. If the centre in which they are followed is not yet included in the IMPRESS 2 network, we will be happy to include it. In any case a single woman may contact directly the main European investigators to arrange the easiest way to collect and record her own clinical data. At that the point (if the local centre does not have the time, capability, or even the interest in collecting the data) the main organising centres will help the local centre. For instance if the local centre has difficulty in finding the controls (healthy pregnant women) the main investigators will arrange to find in another centre the appropriate controls. Our ambitious aim is that each pregnancy occurring in a SSc woman in Europe should be offered inclusion in the IMPRESS 2 project, since we anticipate that the results of the IMPRESS 2 study will be important for all SSc women contemplating a possible pregnancy.
Main European Investigators:
Monika Østensen, National Centre of Pregnancy and Rheumatic Disease, University of Trondheim, Skippervn. 4, N-4550, Farsund, Norway firstname.lastname@example.org
Angela Tincani, Rheumatology, Università degli Studi di Brescia, Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy email@example.com
Antonio Brucato, Internal Medicine, Ospedale Papa Giovanni XXIII (previously named Ospedali Riuniti) Piazza OMS 1, 24127 Bergamo, Italy firstname.lastname@example.org