Primary Immune DeficiencyPREPINCT04581460
Primitive Immunodeficiency and Pregnancy
An observational study of Primary Immune Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- Questionnaire
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with any inherited immune defect included in the CEREDIH national cohort
Who may be able to join
- 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
Who cannot join
- Refusal to participate of the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Primary Immune Deficiency
- Being tested
- Questionnaire
- Keywords
- Primary immune deficiency, Obstetric experiences, Infectious complications, Pregnancy, Postpartum, Contraception
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients entered in the register of the reference Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris, and having reported at least one pregnancy or attempted pregnancy Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious events
Number of infectious events at any time during pregnancy and post-partum
Measured: 18 months
Secondary outcomes (9)
Infectious gynecological complications
Number of infectious gynecological complications during contraception
Measured: Up to 50 years
Onset of pregnancy
Number of pregnancies during reproductive age period
Measured: Up to 50 years
Pregnancy outcomes
Rate of early or late miscarriage, completed pregnancy, live birth and childbearing
Measured: Up to 9 months
Treatments
Number of treatments aiming at preventing infections
Measured: 9 months
Screening of infections
Presence/absence of screening for infections
Measured: 9 months
Occurrence of obstetric complications
Rate of obstetric complications
Measured: 9 months
Contraception effectiveness
Number of unwanted pregnancies
Measured: Up to 50 years
Contraception complications
Number of non-infectious complications of contraception
Measured: Up to 50 years
Deaths and complications in the neonatal period
Number of complications during neonatal period, including death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start30 Nov 2020
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Elise Mallart, Principal investigator, Assistance Publique - Hôpitaux de ParisCaroline Charlier-Woerther, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisNizar Mahlaoui, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581460
- Sponsor's protocol ID
- APHP200747
- Other IDs
- 2020-A01781-38
- Acronym
- PREPI
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mallart E, Francoise U, Driessen M, Blanche S, Lortholary O, Lefort A, Caseris M, Fischer A, Mahlaoui N, Charlier C; PREPI study group. Pregnancy in primary immunodeficiency diseases: The PREPI study. J Allergy Clin Immunol. 2023 Sep;152(3):760-770. doi: 10.1016/j.jaci.2023.05.006. Epub 2023 May 18.
PubMed 37210041
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primitive Immunodeficiency and Pregnancy
- ClinicalTrials.gov ID
- NCT04581460
- Acronym / sponsor ID
- PREPI / APHP200747
- Conditions
- Primary Immune Deficiency
- Keywords
- Primary immune deficiency, Obstetric experiences, Infectious complications, Pregnancy, Postpartum, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairePatients entered in the register of the reference Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris, and having reported at least one pregnancy or attempted pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with any inherited immune defect included in the CEREDIH national cohort
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities. | Other | Patients |
Primary outcome
Infectious events
Time frame: 18 months
Number of infectious events at any time during pregnancy and post-partum
9 secondary outcomes
Infectious gynecological complications
Time frame: Up to 50 years
Onset of pregnancy
Time frame: Up to 50 years
Pregnancy outcomes
Time frame: Up to 9 months
Treatments
Time frame: 9 months
Screening of infections
Time frame: 9 months
Occurrence of obstetric complications
Time frame: 9 months
Contraception effectiveness
Time frame: Up to 50 years
Contraception complications
Time frame: Up to 50 years
Deaths and complications in the neonatal period
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publication: PubMed 37210041Mallart E, Francoise U, Driessen M, Blanche S, Lortholary O, Lefort A, Caseris M, Fischer A, Mahlaoui N, Charlier C; PREPI study group. Pregnancy in primary immunodeficiency diseases: The PREPI study. J Allergy Clin Immunol. 2023 Sep;152(3):760-770. doi: 10.1016/j.jaci.2023.05.006. Epub 2023 May 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise Mallart principal investigator
Assistance Publique - Hôpitaux de Paris
Caroline Charlier-Woerther, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Nizar Mahlaoui, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious events (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.