PREPI: Primitive Immunodeficiency and Pregnancy

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT04581460
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Actual Duration (Months): 16.8
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

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

Condition or Disease	Intervention/Treatment	Phase
Primary Immune Deficiency	Other: Questionnaire

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

• Study Type: Observational
• Actual Enrollment: 99 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Primitive Immunodeficiency and Pregnancy
• Actual Study Start Date: Nov 30, 2020
• Actual Primary Completion Date: Apr 25, 2022
• Actual Study Completion Date: Apr 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Questionnaire; Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.

Outcome Measures

Primary Outcome Measures

1. Infectious events [18 months]

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

Secondary Outcome Measures

1. Infectious gynecological complications [Up to 50 years]

   Number of infectious gynecological complications during contraception

2. Onset of pregnancy [Up to 50 years]

   Number of pregnancies during reproductive age period

3. Pregnancy outcomes [Up to 9 months]

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

4. Treatments [9 months]

   Number of treatments aiming at preventing infections

5. Screening of infections [9 months]

   Presence/absence of screening for infections

6. Occurrence of obstetric complications [9 months]

   Rate of obstetric complications

7. Contraception effectiveness [Up to 50 years]

   Number of unwanted pregnancies

8. Contraception complications [Up to 50 years]

   Number of non-infectious complications of contraception

9. Deaths and complications in the neonatal period [3 months]

   Number of complications during neonatal period, including death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Necker-Enfants Malades	Paris		France	75015

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Elise Mallart, Assistance Publique - Hôpitaux de Paris
• Principal Investigator: Caroline Charlier-Woerther, MD, Assistance Publique - Hôpitaux de Paris
• Study Director: Nizar Mahlaoui, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04581460
• Other Study ID Numbers: APHP200747; 2020-A01781-38
• First Posted: Oct 9, 2020
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Primary immune deficiency; Obstetric experiences; Infectious complications; Pregnancy; Postpartum; Contraception
• Additional relevant MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Jul 13, 2022