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NCT02450396Withdrawn

Pregnancy and Medically Assisted Conception in Rare Diseases

Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Observational
Enrollment
0 (actual)
First submitted
19 May 2015
Start date
Jun 2015
Primary completion date
Jun 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT02450396

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hôpital Cochin
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.