Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
Study NCT ID:
NCT06625866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-03
First Post:
2024-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two hospitals (clusters) will be assigned to intervention and standard of care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episiotomies performed', 'timeFrame': 'During spontaneous or assisted vaginal delivery', 'description': 'Number of episiotomies performed among patients having a vaginal delivery.\n\nEpisiotomy: surgical incision made in the perineum during childbirth to enlarge the vaginal opening and facilitate the delivery.\n\nThere are two main types of episiotomies, classified based on the direction of the incision: Median (the incision is made straight down from the vaginal opening towards the anus) and mediolateral (the incision is made at an angle \\[usually 45 degrees\\] from the vaginal opening towards the side, away from the anus).'}], 'secondaryOutcomes': [{'measure': 'Episiotomy indication documented in the medical record', 'timeFrame': 'During spontaneous or assisted vaginal delivery', 'description': 'Number of episiotomies performed with an indication documented in the medical record among patients having a vaginal delivery.\n\nPotential indications:\n\nNonreassuring fetal status, prolonged or difficult labor, operative vaginal delivery, shoulder dystocia, large for gestational age fetus, breech delivery, rigid perineum, maternal fatigue or exhaustion, preterm delivery.'}, {'measure': 'Number of assisted vaginal deliveries', 'timeFrame': 'At the time of vaginal delivery', 'description': 'Number of assisted deliveries among patients having a vaginal delivery. Assisted vaginal delivery refers to the use of specialized instruments, such as forceps or a vacuum device, to help guide the fetal head out of the birth canal during childbirth.'}, {'measure': 'Number of perineal and cervical lacerations (composite outcome)', 'timeFrame': 'At the time of spontaneous or assisted vaginal delivery', 'description': 'Number of perineal and cervical lacerations (composite outcome) among patients having a vaginal delivery.\n\nThe composite outcome will include any of the following:\n\nPerineal Lacerations:\n\nFirst degree: Injury to Perineal skin only. Second degree: Injury to perineum involving perineal muscles but not involving anal sphincter. Third degree: Injury to perineum involving anal sphincter complex. 3a: Less than 50% of external anal sphincter thickness torn. 3b: More than 50% external anal sphincter thickness torn. 3c. Both external anal sphincter and internal sphincter torn. Fourth degree: Injury to perineum involving anal sphincter complex (external anal sphincter and internal anal sphincter) and anal epithelium.\n\nCervical Laceration:\n\nA cervical laceration during delivery refers to a tear or injury to the cervix that occurs during childbirth.'}, {'measure': 'Rate of transfusion of blood products (composite outcome)', 'timeFrame': 'Administered in the first 24 hours after delivery', 'description': 'Administration of any of the following :\n\nRBCs, fresh frozen plasma (FFP), platelets and cryoprecipitate'}, {'measure': 'Blood loss at the time of delivery', 'timeFrame': 'Within the first hour after spontaneous or assisted vaginal delivery', 'description': 'Estimated or calculated blood loss (mL).'}, {'measure': 'Hematocrit after delivery', 'timeFrame': 'Within 24 hours after delivery', 'description': 'Percentage (%) of red blood cells (RBCs) in the total blood volume.'}, {'measure': 'Pain management after delivery', 'timeFrame': 'Administered in the first 24 hours after vaginal delivery', 'description': 'Description of Nonsteroidal Antiinflammatory Drugs and Opioids administered'}, {'measure': 'Patient satisfaction with the inpatient care received during and after vaginal delivery', 'timeFrame': 'Within the first 24 hours after delivery.', 'description': 'Brief voluntary and anonymous survey designed by the research team to be answered by \\~300 patients.'}, {'measure': 'Rate of surgical site infection', 'timeFrame': 'In the first 6 weeks after vaginal delivery', 'description': 'Surgical site infection related to episiotomies, perineal, or cervical lacerations that occurred at the site of these surgical or traumatic wounds after childbirth.'}, {'measure': 'Rate of surgical site dehiscence', 'timeFrame': 'In the first 6 weeks after vaginal delivery', 'description': 'Partial or complete wound reopening along a surgical incision or laceration previously closed (e.g., episiotomies, perineal lacerations, cervical lacerations).'}, {'measure': 'Five-minute Apgar', 'timeFrame': 'Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery', 'description': "5-Minute Apgar Score Components:\n\nThe Apgar score assesses five key signs of a newborn's health, each assigned a score of 0, 1, or 2, for a total possible score of 10:\n\n1. Appearance (skin color)\n\n * 0: Blue or pale all over.\n * 1: Body pink, but extremities blue.\n * 2: Entire body pink.\n2. Pulse (heart rate)\n\n * 0: No heartbeat.\n * 1: Fewer than 100 beats per minute.\n * 2: At least 100 beats per minute.\n3. Grimace (reflex irritability, response to stimulation)\n\n * 0: No response to stimulation.\n * 1: Grimace or weak response when stimulated.\n * 2: Strong cry or active withdrawal in response to stimulation.\n4. Activity (muscle tone)\n\n * 0: Limp, no movement.\n * 1: Some flexion of extremities.\n * 2: Active movement.\n5. Respiration (breathing effort)\n\n * 0: Not breathing.\n * 1: Weak or irregular breathing.\n * 2: Strong cry, normal breathing."}, {'measure': 'Rate of NICU Admission', 'timeFrame': 'In the first 24 hours after delivery.', 'description': 'Transfer and care of a newborn in the Neonatal Intensive Care Unit (NICU) to provide intensive medical care for premature, ill, or high-risk newborns.'}, {'measure': 'Rate of Neonatal death', 'timeFrame': 'Within the first 28 days of life', 'description': 'Neonatal death refers to the death of a newborn within the first 28 days of life. This period is further divided into two phases:\n\n* Early neonatal death: Neonatal death within the first 7 days of life.\n* Late neonatal death: Neonatal death occurring between 7 and 28 days of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Episiotomy', 'Episiotomy Extended by Laceration', 'Episiotomy Infection', 'Episiotomy Wound']}, 'descriptionModule': {'briefSummary': 'This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.\n\nExclusion Criteria:\n\n* Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.'}, 'identificationModule': {'nctId': 'NCT06625866', 'briefTitle': 'Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Panamericana'}, 'officialTitle': 'Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study', 'orgStudyIdInfo': {'id': '101 - 101 - 001 - 24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral intervention', 'description': 'The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies.', 'interventionNames': ['Behavioral: Feedback and information']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals.'}], 'interventions': [{'name': 'Feedback and information', 'type': 'BEHAVIORAL', 'description': 'The healthcare professionals in the intervention arm will be exposed to feedback and information behavioral strategies. Namely, interns, residents, obstetricians/gynecologists, and nurses will receive written feedback about the episiotomy rates in the hospital each month during the study period. Moreover, at least two academic sessions will be designed to outline the indications, surgical technique, complications, and surgical ethics for the procedure (i.e., episiotomy). Likewise, each session will also include a patient testimonial about their experience during delivery and their follow-up when an episiotomy was performed.\n\nThe feedback intervention will be provided for 2 months, and the feedback intervention + the information intervention will be provided for 2 additional months.', 'armGroupLabels': ['Behavioral intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mario I Lumbreras-Marquez, MD, MMSc', 'role': 'CONTACT', 'email': 'mlumbreras@up.edu.mx', 'phone': '+52 55 54821600', 'phoneExt': '5695'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Panamericana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad de la Salud - UNISA', 'class': 'UNKNOWN'}, {'name': 'IMSS-Bienestar', 'class': 'UNKNOWN'}, {'name': 'Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Public Health and Epidemiology Department', 'investigatorFullName': 'Mario I. Lumbreras-Marquez, MD, MMSc', 'investigatorAffiliation': 'Universidad Panamericana'}}}}