Determining if Biologics for Atopic Diseases During Pregnancy Increased the Risk of Adverse Maternal and Fetal Outcomes

Overview

About this study

The purpose of the study is to describe whether the use of biologics for atopic diseases during pregnancy increased the risk of adverse maternal and fetal outcomes, including preterm delivery, stillbirth, low birth weight, or congenital malformations.

This IRB application will use data collected for IRB# 22-006566, which shares the same protocol

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Pregnant patients and their offsprings who were exposed to biologics during preconception period and/or during pregnancy attending to the Mayo Clinic practice that were identified with the following diagnoses:
- Atopic disease;
- Severe asthma;
- Allergic asthma;
- Eosinophilic asthma;
- Eczema;
- Atopic dermatitis;
- Chronic spontaneous urticaria;
- Chronic idiopathic urticaria;
- Chronic rhinosinusitis with nasal polyps;
- Eosinophilic esophagitis;
- Eosiphilic granulomatosis with polyangiitis;
- Hypereosinophilic syndrome.

Exclusion Criteria:

> 55 years of age.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Sergio Chiarella, M.D.	Open for enrollment	Contact information: Kay Bachman R.N., C.C.R.C. (507) 284-5689 bachman.kay@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sergio Chiarella, M.D.

Open for enrollment

Contact information:

Kay Bachman R.N., C.C.R.C.

(507) 284-5689

bachman.kay@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials