Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-03-13 @ 2:05 PM
Study NCT ID:
NCT05936866
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antenatal Exercises on Maternal Birth Outcomes
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': '13th Week', 'description': 'Changes from the baseline outcome of Mode of Delivery will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist.'}, {'measure': 'Duration of labour', 'timeFrame': '13th Week', 'description': 'Changes from the baseline outcome of Duration of labour will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist. It will be measured in minutes/hours.'}, {'measure': 'Number of vaginal inductions', 'timeFrame': '13th Week', 'description': 'Changes from the baseline outcome of Number of vaginal inductions will be taken from the delivery and labor records of the patients and also from the consultant Gynecologist. It will be measured in minutes/hours.'}], 'secondaryOutcomes': [{'measure': 'Urogenital Distress Inventory', 'timeFrame': '15th Week', 'description': 'UDI-6 is a widely used tool for the assessment of quality of life and symptoms of urinary incontinence in women. It is the short form which consists of 6 questions which are: frequent urination, leakage related to feeling of urgency, leakage related to activity, coughing or sneezing. Amount of drops of leakage, difficulty emptying the bladder and pain and discomfort in the lower abdominal or genital area. Scoring: Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Related', 'Pelvic Floor Muscle Weakness', 'Delivery Delayed'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The study is aimed to determine the effects of pelvic floor stretching Vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.', 'detailedDescription': 'The effects of pelvic floor muscle exercises on the symptoms of postpartum urinary distress is not known, so there is a need to determine whether strengthening or stretching of pelvic floor muscles help in reducing the risk of developing urogenital distress in postpartum period of females. The positive effect of pelvic floor muscle training on duration of labor and maternal birth outcomes is understood. As stated in a systemic review of pelvic floor interventions during pregnancy. The researches done on effect of pelvic floor muscle exercises, included once a week supervised session of sustained pelvic floor muscle contractions with rest intervals and fast contractions with respective rest intervals along with daily home sessions of the same exercises.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primigravida\n\nExclusion Criteria:\n\n* Any Contraindications to performing an exercise during pregnancy based on recommendations of the American College of Obstetricians and Gynecologists (ACOG)\n* females opting for Elective C section'}, 'identificationModule': {'nctId': 'NCT05936866', 'briefTitle': 'Effects of Antenatal Exercises on Maternal Birth Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect of Antenatal Pelvic Floor Stretching Vs Strengthening Exercises on Maternal Birth Outcomes in Primigravida', 'orgStudyIdInfo': {'id': 'REC/01537 Omama Sadaf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic floor stretching', 'description': 'Pelvic floor stretching exercises', 'interventionNames': ['Other: Pelvic floor stretching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic floor strengthening', 'description': 'Pelvic floor strengthening Exercises', 'interventionNames': ['Other: Pelvic floor strengthening']}], 'interventions': [{'name': 'Pelvic floor stretching', 'type': 'OTHER', 'description': 'Week 1 to 4: Pelvic floor muscles awareness, Breathing exercises , seated pelvic tilts, cat stretches, seated hip openers (2 sets, 8 reps, sustained for 6 seconds) Week 5 to 8: Pelvic floor muscles awareness, Breathing exercises ,seated pelvic tilts, cat stretches, Seated hip openers, Relaxed Frog (2 sets, 8 reps, sustained for 6 seconds) Week 9 to 13: Pelvic floor muscles awareness, Breathing exercises, seated pelvic tilts, cat stretches, Seated hip openers, Relaxed Frog side lying clamshells, mini squats with support (2 sets, 9 reps, sustained for 7 seconds)', 'armGroupLabels': ['Pelvic floor stretching']}, {'name': 'Pelvic floor strengthening', 'type': 'OTHER', 'description': 'Week 1 to 4: Pelvic floor muscles awareness, Breathing exercises, 2 Sets of 10 Reps for pelvic floor squeeze and release Seated marching with elastic band with pelvic floor squeeze.\n\nWeek 5 to 8: 2 sets x 9 Reps for Pelvic floor squeeze and release, Seated marching with elastic band with pelvic. 2 Sets x 8 Reps for bridging with pelvic floor squeeze, side lying hip circles Week 9 to 13: 2 sets 10 reps for Pelvic floor squeeze-and-release, Seated marching with elastic band with pelvic floor squeeze, pelvic bridging with pelvic floor squeeze, side lying hip circles with pelvic floor squeeze. 2 sets, 8 reps for . side lying Clamshells with resistance band and pelvic floor squeeze and plie squats with pelvic floor squeeze', 'armGroupLabels': ['Pelvic floor strengthening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22020', 'city': 'Abbottabad', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Doctors hospital', 'geoPoint': {'lat': 34.1463, 'lon': 73.21168}}], 'overallOfficials': [{'name': 'Sarah Ehsan, PP-DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}