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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04775277
Other study ID # Soh-Med-21-02-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date February 20, 2021

Study information

Verified date February 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date February 20, 2021
Est. primary completion date April 30, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria: - Patients with pulmonary diseases during pregnancy Exclusion Criteria: - Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.

Study Design


Locations

Country Name City State
Egypt Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. Review. Erratum in: Am J Respir Crit Care Med2002 Aug 1;166(3):426. — View Citation

Sharma CP, Aggarwal AN, Vashisht K, Jindal SK. Successful outcome of pregnancy in idiopathic pulmonary fibrosis. J Assoc Physicians India. 2002 Nov;50:1446-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary any adverse events including gestational complication or disease specific complication e.g (development of respiratory failure, need for ICU admission). maternal outcome from the start of inclusion to the study till termination of pregnancy, average 9 months period
Primary neonatal outcome any unfavorable neonatal outcome as low birth weight December 2018 to April 2020
Primary neonatal outcome any unfavorable neonatal outcome as prematurity or neonatal death. December 2018 to April 2020
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