Bronchial AsthmaNCT05180877
Asthma During Pregnancy; Impact of Severity
An observational study of Bronchial Asthma, run by Sohag University at 1 site in Egypt.
Trial summary
bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bronchial Asthma
- How many people
- 137 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 30 Jun 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant asthmatic female patients presenting in first trimester to inpatient or outpatients clinic of chest department.
Who may be able to join
- pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department.
Who cannot join
- Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asthma During Pregnancy; Impact of Asthma Severity
bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome
Read the detailed description
This was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).This study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma, pregnancy, Asthma severity
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Intermittent& mild persistent asthma | According to asthma severity assessment, this group included asthmatic pregnant females patients with intermittent asthma and mild persistent asthma | |
| Moderate& severe persistent asthma | According to asthma severity assessment, this group included asthmatic pregnant females patients with Moderate\& severe persistent asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal complications
Occurrence any pregnancy related complication to the parturient women was recorded in both study groups.
Measured: from the start of inclusion to the study till termination of pregnancy, average 9 months period
perinatal complications
Incidence of any fetal or neonatal complication was recorded
Measured: from the start of inclusion to the study till termination of pregnancy, average 9 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Apr 2019
- Primary completion31 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 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
- NCT05180877
- Sponsor's protocol ID
- Soh-Med-21-09-35
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019 Jun 18;7:246. doi: 10.3389/fped.2019.00246. eCollection 2019.
PubMed 31275909Robijn AL, Murphy VE, Gibson PG. Recent developments in asthma in pregnancy. Curr Opin Pulm Med. 2019 Jan;25(1):11-17. doi: 10.1097/MCP.0000000000000538.
PubMed 30407268National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma During Pregnancy; Impact of Asthma Severity
- ClinicalTrials.gov ID
- NCT05180877
- Acronym / sponsor ID
- Soh-Med-21-09-35
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma, pregnancy, Asthma severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jan 2022 (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.
bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome
Detailed description
This was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).This study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent& mild persistent asthma | – | –According to asthma severity assessment, this group included asthmatic pregnant females patients with intermittent asthma and mild persistent asthma |
| Moderate& severe persistent asthma | – | –According to asthma severity assessment, this group included asthmatic pregnant females patients with Moderate\& severe persistent asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant asthmatic female patients presenting in first trimester to inpatient or outpatients clinic of chest department.
Key inclusion criteria (1 listed)
- pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department.
Key exclusion criteria (1 listed)
- Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.
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
maternal complications
Time frame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
Occurrence any pregnancy related complication to the parturient women was recorded in both study groups.
perinatal complications
Time frame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
Incidence of any fetal or neonatal complication was recorded
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 6 Jan 2022.
- Background: PubMed 31275909Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019 Jun 18;7:246. doi: 10.3389/fped.2019.00246. eCollection 2019.
- Background: PubMed 30407268Robijn AL, Murphy VE, Gibson PG. Recent developments in asthma in pregnancy. Curr Opin Pulm Med. 2019 Jan;25(1):11-17. doi: 10.1097/MCP.0000000000000538.
- Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
- Individual participant dataSharing planned: No
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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 Bronchial Asthma, 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 6 Jan 2022. 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?
maternal complications (time frame: from the start of inclusion to the study till termination of pregnancy, average 9 months period). The study lists 2 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 NCT05180877, which also lists 3 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 6 Jan 2022.