Clinical trial NCT06031220: Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
Official title: Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: forced vital capacity (FVC)
timeFrame: FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
measure: Forced Expiratory Volume in 1 Sec (FEV1)
timeFrame: FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)
measure: FEV1/FVC
timeFrame: FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Soaad kafafy university hospital
Study officials:
affiliation: Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC
name: Radwa S Mahmoud, PhD
role: STUDY_CHAIR
affiliation: Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST
name: Shimaa HA roshdy, PhD
role: STUDY_CHAIR
affiliation: Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST
name: Ayman A Elsallamy, PhD
role: STUDY_CHAIR
affiliation: Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
name: Doaa S Mohamed El-sayed, PhD
role: STUDY_CHAIR
affiliation: Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC
name: Mina AG Elias, PhD
role: STUDY_CHAIR
affiliation: Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC
name: Noha A Fouad, PhD
role: PRINCIPAL_INVESTIGATOR
References: