NCT04775277

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 22, 2021

Last Update Submit

February 26, 2021

Conditions

Keywords

IPFpregnancy

Outcome Measures

Primary Outcomes (3)

  • 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

  • neonatal outcome

    any unfavorable neonatal outcome as low birth weight

    December 2018 to April 2020

  • neonatal outcome

    any unfavorable neonatal outcome as prematurity or neonatal death.

    December 2018 to April 2020

Study Arms (2)

cases

pregnant female with idiopathic pulmonary fibrosis

control group

pregnant female with bronchial asthma

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients were diagnosed to have IPF of childbearing age, patients were presented during pregnancy

You may qualify if:

  • Patients with pulmonary diseases during pregnancy

You may not qualify if:

  • Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

Location

Related 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. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.

    PMID: 11790668BACKGROUND
  • 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.

    PMID: 12583483BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 1, 2021

Study Start

December 1, 2018

Primary Completion

April 30, 2020

Study Completion

February 20, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations