Idiopathic Pulmonary FibrosisNCT04775277
Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy
An observational study of Idiopathic Pulmonary Fibrosis, run by Sohag University at 1 site in Egypt.
Trial summary
case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Adult
Study population: Female patients were diagnosed to have IPF of childbearing age, patients were presented during pregnancy
Who may be able to join
- Patients with pulmonary diseases during pregnancy
Who cannot join
- Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, pregnancy
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases | pregnant female with idiopathic pulmonary fibrosis | |
| control group | pregnant female with bronchial asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
any adverse events including gestational complication or disease specific complication
e.g (development of respiratory failure, need for ICU admission). maternal outcome
Measured: 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
Measured: December 2018 to April 2020
neonatal outcome
any unfavorable neonatal outcome as prematurity or neonatal death.
Measured: December 2018 to April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Dec 2018
- Primary completion30 Apr 2020
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohammed Abdelraheem Esmaeel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775277
- Sponsor's protocol ID
- Soh-Med-21-02-38
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11790668Sharma CP, Aggarwal AN, Vashisht K, Jindal SK. Successful outcome of pregnancy in idiopathic pulmonary fibrosis. J Assoc Physicians India. 2002 Nov;50:1446-8.
PubMed 12583483
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Idiopathic Pulmonary Fibrosis With Pregnancy
- ClinicalTrials.gov ID
- NCT04775277
- Acronym / sponsor ID
- Soh-Med-21-02-38
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
case-control study was conducted between December 2018 to April 2020. To document outcome of IPF with pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –pregnant female with idiopathic pulmonary fibrosis |
| control group | – | –pregnant female with bronchial asthma |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female patients were diagnosed to have IPF of childbearing age, patients were presented during pregnancy
Key inclusion criteria (1 listed)
- Patients with pulmonary diseases during pregnancy
Key exclusion criteria (1 listed)
- Patients with pulmonary diseases other than IPF and bronchial asthma were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
neonatal outcome
Time frame: December 2018 to April 2020
any unfavorable neonatal outcome as low birth weight
neonatal outcome
Time frame: December 2018 to April 2020
any unfavorable neonatal outcome as prematurity or neonatal death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 11790668American 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.
- Background: PubMed 12583483Sharma CP, Aggarwal AN, Vashisht K, Jindal SK. Successful outcome of pregnancy in idiopathic pulmonary fibrosis. J Assoc Physicians India. 2002 Nov;50:1446-8.
- Individual participant dataSharing planned: Undecided
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.