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OpenTrials
Completed

NCT Number: NCT04581460

Primitive Immunodeficiency and Pregnancy

The management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner.

The aim the research is to study the obstetric features and outcome of patients with primary immune defects.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

Primary immune deficiencies constitute a large group of immune system disorders of genetic origin which can associate, to varying degrees, an increased susceptibility to infections and immunopathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, tumors malignant.

Although their prevalence remains underestimated, there has been an increase in the number of cases diagnosed in the past 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants and the diagnostic incidence is 400 new cases per year in France. Major improvement in the management of primary immunodeficiencies have drastically changed patients outcome. Most patients now reach adulthood and the possibility of carrying out a pregnancy project, that has already reported for patients suffering from hypogammaglobulinemia or variable common immune deficiency, is now increasingly reported for other types of inherited immunodeficiencies. Whereas the management of patients with hereditary immunodeficiencies is increasingly codified, contraception and pregnancy have not yet been the subject of recommendations: medical monitoring and the prevention of infectious complications thus remain at the discretion of the practitioner.

The aim the research is to study the obstetric experiences of patients with a primary immune deficiency, paying particular attention to infectious complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult woman with Hereditary Immune Deficits and entered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris) register
  • Patient having reported at least one pregnancy or attempted pregnancy
  • Patient not opposing to participation in research

Exclusion criteria

  • Refusal to participate of the study

Treatment and study plan

Questionnaire

Other

Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.

Primary outcomes

  1. Infectious events

    Time frame: 18 months

    Number of infectious events at any time during pregnancy and post-partum

Secondary outcomes

  1. Infectious gynecological complications

    Time frame: Up to 50 years

    Number of infectious gynecological complications during contraception

  2. Onset of pregnancy

    Time frame: Up to 50 years

    Number of pregnancies during reproductive age period

  3. Pregnancy outcomes

    Time frame: Up to 9 months

    Rate of early or late miscarriage, completed pregnancy, live birth and childbearing

  4. Treatments

    Time frame: 9 months

    Number of treatments aiming at preventing infections

  5. Screening of infections

    Time frame: 9 months

    Presence/absence of screening for infections

  6. Occurrence of obstetric complications

    Time frame: 9 months

    Rate of obstetric complications

  7. Contraception effectiveness

    Time frame: Up to 50 years

    Number of unwanted pregnancies

  8. Contraception complications

    Time frame: Up to 50 years

    Number of non-infectious complications of contraception

  9. Deaths and complications in the neonatal period

    Time frame: 3 months

    Number of complications during neonatal period, including death

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: PREPI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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