NCT06031220

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

September 3, 2023

Last Update Submit

November 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

study group

EXPERIMENTAL

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.

Other: deep breathing exercise inform of diaphragmatic and costal breathing

control group

NO INTERVENTION

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.

Interventions

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

study group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soaad kafafy university hospital

Giza, Egypt

Location

Study Officials

  • 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

    STUDY CHAIR
  • Noha A Fouad, PhD

    Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for women health

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 11, 2023

Study Start

October 1, 2022

Primary Completion

May 30, 2023

Study Completion

June 5, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations