Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy

February 26, 2021 updated by: Hend Mohammed Abdelraheem Esmaeel, Sohag University
case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients with pulmonary diseases during pregnancy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
cases
pregnant female with idiopathic pulmonary fibrosis
control group
pregnant female with bronchial asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
any adverse events including gestational complication or disease specific complication
Time Frame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
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
Time Frame: December 2018 to April 2020
any unfavorable neonatal outcome as low birth weight
December 2018 to April 2020
neonatal outcome
Time Frame: December 2018 to April 2020
any unfavorable neonatal outcome as prematurity or neonatal death.
December 2018 to April 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

February 20, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-02-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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