Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06980220
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-12', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Perineal Tears Following Perineal Massage with Lubricating Gel at Expulsion', 'timeFrame': '15/10/2023 - 15/05/2024'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perineal Massage', 'Perineum/Injuries', 'Labor, Obstetric', 'Episiotomy']}, 'descriptionModule': {'briefSummary': "The primary goal is to assess whether this practice reduces the incidence and severity of perineal tears. Secondary objectives include evaluating the impact of the massage on perineal pain in the postpartum period and on the episiotomy rate. Participants will include primiparous women with singleton pregnancies who delivered spontaneously via vaginal birth. Exclusion criteria include instrumental deliveries, breech presentations, and preterm births. Data will be collected through a questionnaire filled out by midwives immediately after birth, as well as additional data extracted from medical records. All data will be anonymized using a birth number code. The questionnaire collects information on whether a perineal massage was performed, the type of product used, the birth position, use of warm compresses, performance of the Ritgen maneuver, and perineal outcomes. The medical record will provide demographic and clinical data, including the mother's age, BMI, labor duration, pushing time, newborn weight, and head circumference. The study aims to provide evidence on whether perineal massage with gel at expulsion is an effective strategy to prevent severe perineal trauma and improve postpartum recovery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will select participants from primiparous women (first-time mothers) who have delivered through spontaneous vaginal births at the hospital. The population will consist of women with singleton pregnancies who are undergoing vaginal delivery without any complications requiring instrumental intervention or preterm delivery. The study will focus on a cohort of women who have received care from midwives, ensuring consistency in the delivery approach. Participants will be selected based on the inclusion criteria outlined and will be monitored for perineal outcomes, including the occurrence of perineal tears and postpartum pain.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy\n* Spontaneous vaginal delivery\n* Primiparous women (first-time mothers)\n\nExclusion Criteria:\n\n* Instrumental births\n* In-seat births\n* Premature births'}, 'identificationModule': {'nctId': 'NCT06980220', 'briefTitle': 'Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Gonesse'}, 'officialTitle': 'Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes', 'orgStudyIdInfo': {'id': '0043_MATERNITE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gonesse', 'country': 'France', 'facility': 'France', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Gonesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}