Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-04 @ 8:56 AM
Study NCT ID:
NCT05392660
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upright Position During First Stage of Labour
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': ['CARE_PROVIDER'], 'maskingDescription': 'Allocation of the women to study or control group was carried out through a person not involved in the study nurses in charge during the shift. This allocation was concealed from person allocating a woman into the trial (nurses)'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of labor pain assessed by Visual analogue pain intensity scale', 'timeFrame': 'during the procedure', 'description': 'Assessment of labor pain assessed by VAS (Visual analogue pain intensity scale ).It is a self-reported 10 cm horizontal line which represented the subjective estimation of pain intensity. It comprised 0-10-point numerical scale, No pain (0), Mild pain (\\< 4), Moderate pain (4-6), Sever pain (7-10).'}, {'measure': 'duration of first stage of labor', 'timeFrame': 'during the procedure', 'description': 'upright position may decrease the duration of first stage of labor'}], 'secondaryOutcomes': [{'measure': 'duration of second stage of labor', 'timeFrame': 'immediately after intervention', 'description': 'upright position may decrease the duration of second stage of labor'}, {'measure': 'fetal outcome', 'timeFrame': 'during the procedure', 'description': 'fetal well being through fetal heart rate assessment assessed by CTG (cardio toco graph ) machine'}, {'measure': 'Neonatal outcome', 'timeFrame': 'immediately after intervention', 'description': 'neonatal condition after delivery assessed by a standardized APGAR score tool by allocating scores to five simple criteria Activity (Muscle tone), Pulse (Heart rate), Grimace (reflex irritability) Appearance (Skin color) \\& Respiratory effort (breathing). A total score (0-3) revealed sever neonatal distress, (4-7) indicated moderate distress \\& (8-10) indicated absence of difficulty in adjusting to extra uterine live.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['First stage of labor', 'Upright position', 'Labor outcomes'], 'conditions': ['Effects of Movement']}, 'descriptionModule': {'briefSummary': 'There are several physiological advantages for being upright during labour. These include the effect of gravity on the fetus within the uterus; reduced risk of aorto-caval compression this maximizes uterine blood flow to the placenta and fetus during labour and more efficient contractions which lead to shorter first and second stage of labor. In addition, being upright during labour provide better alignment of the fetus; and increased pelvic outlet when the woman is in squatting and kneeling positions'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primipara parturient women who admitted to delivery unit;\n* in early active phase of 1st stage of labor (not more than 4cm),\n* age between 20-35 years,\n* had a single, viable, and full term (≥ 37 weeks),\n* with normal fetal heart rate pattern (120-160 b/min),\n* fetus in occipto anterior position\n* free from medical or obstetrical disorders that may interrupt labor progress\n\nExclusion Criteria:\n\n* Any women out of inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05392660', 'briefTitle': 'Upright Position During First Stage of Labour', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Upright Position During First Stage of Labour On Labour Outcome: An Evidence Based Approach', 'orgStudyIdInfo': {'id': '2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study arm', 'description': 'assumed upright position during first stage of labor', 'interventionNames': ['Other: assumed upright position during first stage of labor']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'hospital routine care'}], 'interventions': [{'name': 'assumed upright position during first stage of labor', 'type': 'OTHER', 'description': 'The study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling \\& squatting positions )', 'armGroupLabels': ['study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of nursing Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Rabab sabry hassen mohamed', 'investigatorAffiliation': 'Cairo University'}}}}