Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06031220
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-18', 'studyFirstSubmitDate': '2023-09-03', 'studyFirstSubmitQcDate': '2023-09-03', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'forced vital capacity (FVC)', 'timeFrame': 'FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)', 'description': 'inspiratory reserve volume + tidal volume+ expiratory reserve volume'}, {'measure': 'Forced Expiratory Volume in 1 Sec (FEV1)', 'timeFrame': 'FEV1 will be applied at 27th week gestation and at 36th weeks gestation (3 months)', 'description': 'Pulmonary Function Tests: (Forced Expiratory Volume in 1 Sec)'}, {'measure': 'FEV1/FVC', 'timeFrame': 'FEV1/FVC will be applied at 27th week gestation and at 36th weeks gestation (3 months)', 'description': 'ratio between Forced Expiratory Volume in 1 Sec (FEV1) and forced vital capacity (FVC)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy', 'detailedDescription': '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.\n\nMany 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women will be in 27th week gestation\n* They will be recruited from Soaad kafafy university hospital\n* Their age between 25-35 years old\n* Their BMI ≥30Kg/m2\n\nExclusion Criteria:\n\n* Pregnant women with any pulmonary disorders before pregnancy\n* Women suffering from any physical or mental disorders.\n* Pregnant women with gestational diabetes\n* Pregnant women with gestational hypertension\n* Pregnant women with asthma'}, 'identificationModule': {'nctId': 'NCT06031220', 'briefTitle': 'Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': '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.', 'interventionNames': ['Other: deep breathing exercise inform of diaphragmatic and costal breathing']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': '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': [{'name': 'deep breathing exercise inform of diaphragmatic and costal breathing', 'type': 'OTHER', 'description': 'deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Soaad kafafy university hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Radwa S Mahmoud, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ass. Prof. Dept of PT for pediatrics, Faculty of PT, Cairo University and BUC'}, {'name': 'Shimaa HA roshdy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of PT Dept of PT for cardiopulmonary and geriatric, Faculty of PT, MUST'}, {'name': 'Ayman A Elsallamy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of obstetrics and gynecology, Ob/ GYN dept MUST'}, {'name': 'Doaa S Mohamed El-sayed, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC"}, {'name': 'Mina AG Elias, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of PT, Dept. of PT for internal medicine and geriatric, Faculty of PT, BUC'}, {'name': 'Noha A Fouad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Lecturer of PT, Dept. of PT for women's health, Faculty of PT, BUC"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for women health', 'investigatorFullName': 'Noha Ahmed Fouad Abd-Elrahman', 'investigatorAffiliation': 'Badr University'}}}}