Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy

Pregnancy Related Clinical Trial

Official title:

Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031220
• Other study ID #: P.T.REC/012/004052
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy Related

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)