Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Soaad kafafy university hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
30 women with twin pregnancy during the third trimester at 27th weeks gestation 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 at 27th week gestation and at 36th weeks gestation.
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deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,
|
|
No Intervention: control group
30 women with twin pregnancy during the third trimester at 27th weeks gestation will not receive any special treatment and will be assessed with pulmonary function test at 27th week gestation and at 36th weeks gestation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced vital capacity (FVC)
Time Frame: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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inspiratory reserve volume + tidal volume+ expiratory reserve volume
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FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
|
|
Forced Expiratory Volume in 1 Sec (FEV1)
Time Frame: FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)
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FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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FEV1/FVC
Time Frame: FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)
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FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Radwa S Mahmoud, PhD, Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC
- Study Chair: Shimaa HA roshdy, PhD, Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST
- Study Chair: Ayman A Elsallamy, PhD, Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST
- Study Chair: Doaa S Mohamed El-sayed, PhD, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
- Study Chair: Mina AG Elias, PhD, Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC
- Principal Investigator: Noha A Fouad, PhD, Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/004052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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