NCT05180877

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

April 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

November 20, 2021

Last Update Submit

December 18, 2021

Conditions

Keywords

Bronchial asthmaAsthmapregnancyAsthma severity

Outcome Measures

Primary Outcomes (2)

  • maternal complications

    Occurrence any pregnancy related complication to the parturient women was recorded in both study groups.

    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

    from the start of inclusion to the study till termination of pregnancy, average 9 months period

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant asthmatic women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant asthmatic female patients presenting in first trimester to inpatient or outpatients clinic of chest department.

You may qualify if:

  • pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department.

You may not qualify if:

  • Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82425, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 31275909BACKGROUND
  • Robijn 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.

    PMID: 30407268BACKGROUND
  • National 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.

    PMID: 17983880BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

November 20, 2021

First Posted

January 6, 2022

Study Start

April 1, 2019

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

January 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations