Clinical trial NCT02450396: Pregnancy and Medically Assisted Conception in Rare Diseases
Official title: Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Psoriatic Arthritis
Systemic Lupus Erythematosus
Antiphospholipid Syndrome
Sjogren Syndrome
Scleroderma
Myositis
Vasculitis
Mastocytosis
Various Autoimmune and/or Systemic and/or Rare Diseases
Keywords: Rare diseases
pregnancy
pregnancy,
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: SNFMI
name: SFR
name: CRAT
First posted: 2015-05-21
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman with a rare and/or systemic disease Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure

Brief summary: Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.


Eligibility criteria: Inclusion Criteria:

* Woman with a rare and/or systemic disease
* Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure
* Patient agreed to participate

Exclusion Criteria:

* Adults under guardianship
* People hospitalised without their consent and not protected by the law
* Persons deprived of their liberty

Primary outcomes:
measure: "good" obstetric outcome
timeFrame: 35 week gestation until 1 year Post Partum
Secondary outcomes:
measure: Define the best therapeutic management strategies
timeFrame: 2 years
measure: Conduct pharmacoepidemiologic studies
timeFrame: 2 years
measure: Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).
timeFrame: 9 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Hôpital Cochin
name: Nathalie Costedoat-Chalumeau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larosa M, Le Guern V, Guettrot-Imbert G, Morel N, Abisror N, Morati-Hafsaoui C, Orquevaux P, Diot E, Doria A, Sarrot-Reynauld F, Limal N, Queyrel V, Souchaud-Debouverie O, Sailler L, Le Besnerais M, Goulenok T, Molto A, Pannier-Metzger E, Sentilhes L, Mouthon L, Lazaro E, Costedoat-Chalumeau N; GR2 Group. Evaluation of lupus anticoagulant, damage, and remission as predictors of pregnancy complications in systemic lupus erythematosus: the French GR2 study. Rheumatology (Oxford). 2022 Aug 30;61(9):3657-3666. doi: 10.1093/rheumatology/keab943.