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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06031220
Other study ID # P.T.REC/012/004052
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date June 5, 2023

Study information

Verified date November 2023
Source Badr University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy


Description:

Physiological changes during pregnancy impose numerous changes on the respiratory system that can affect the health of both mother and foetus. Regarding the importance of the normal breathing in the health of mother and foetus. Many investigators have studied pulmonary function tests during normal pregnancy, most of them found a significant decrease in pulmonary function test parameters during all pregnancy trimesters. Others showed that the PFTs parameters are normal in the first trimester but there was significant decrease in them in the second and third trimesters, or in the third trimester only. Study Design: Randomized control trial Sixty twin pregnant women during the third trimester i (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups; control group and study group ( study group only will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied for both groups at 27th week gestation and at 36th weeks gestation.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 5, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 35 Years
Eligibility Inclusion Criteria: - All pregnant women will be in 27th week gestation - They will be recruited from Soaad kafafy university hospital - Their age between 25-35 years old - Their BMI =30Kg/m2 Exclusion Criteria: - Pregnant women with any pulmonary disorders before pregnancy - Women suffering from any physical or mental disorders. - Pregnant women with gestational diabetes - Pregnant women with gestational hypertension - Pregnant women with asthma

Study Design


Related Conditions & MeSH terms


Intervention

Other:
deep breathing exercise inform of diaphragmatic and costal breathing
deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,

Locations

Country Name City State
Egypt Soaad kafafy university hospital Giza

Sponsors (1)

Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary forced vital capacity (FVC) inspiratory reserve volume + tidal volume+ expiratory reserve volume FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Primary Forced Expiratory Volume in 1 Sec (FEV1) Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec) FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Primary FEV1/FVC ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC) FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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