An interventional study of Feedback and information in Episiotomy, Episiotomy Extended by Laceration and Episiotomy Infection, sponsored by Universidad Panamericana. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Universidad Panamericana · Not applicable, Interventional, and Health services research
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 2 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Universidad Panamericana is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies.
Behavioral: Feedback and information
The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals.
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. The feedback intervention will be provided for 2 months, and the feedback intervention + the information intervention will be provided for 2 additional months.
Number of episiotomies performed
Number of episiotomies performed among patients having a vaginal delivery. Episiotomy: surgical incision made in the perineum during childbirth to enlarge the vaginal opening and facilitate the delivery. There 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).
Time frame: During spontaneous or assisted vaginal delivery
Episiotomy indication documented in the medical record
Number of episiotomies performed with an indication documented in the medical record among patients having a vaginal delivery. Potential indications: Nonreassuring 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.
Time frame: During spontaneous or assisted vaginal delivery
Number of assisted vaginal deliveries
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.
Time frame: At the time of vaginal delivery
Number of perineal and cervical lacerations (composite outcome)
Number of perineal and cervical lacerations (composite outcome) among patients having a vaginal delivery. The composite outcome will include any of the following: Perineal Lacerations: First 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. Cervical Laceration: A cervical laceration during delivery refers to a tear or injury to the cervix that occurs during childbirth.
Time frame: At the time of spontaneous or assisted vaginal delivery
Rate of transfusion of blood products (composite outcome)
Administration of any of the following : RBCs, fresh frozen plasma (FFP), platelets and cryoprecipitate
Time frame: Administered in the first 24 hours after delivery
Blood loss at the time of delivery
Estimated or calculated blood loss (mL).
Time frame: Within the first hour after spontaneous or assisted vaginal delivery
Hematocrit after delivery
Percentage (%) of red blood cells (RBCs) in the total blood volume.
Time frame: Within 24 hours after delivery
Pain management after delivery
Description of Nonsteroidal Antiinflammatory Drugs and Opioids administered
Time frame: Administered in the first 24 hours after vaginal delivery
Patient satisfaction with the inpatient care received during and after vaginal delivery
Brief voluntary and anonymous survey designed by the research team to be answered by \~300 patients.
Time frame: Within the first 24 hours after delivery.
Rate of surgical site infection
Surgical site infection related to episiotomies, perineal, or cervical lacerations that occurred at the site of these surgical or traumatic wounds after childbirth.
Time frame: In the first 6 weeks after vaginal delivery
Rate of surgical site dehiscence
Partial or complete wound reopening along a surgical incision or laceration previously closed (e.g., episiotomies, perineal lacerations, cervical lacerations).
Time frame: In the first 6 weeks after vaginal delivery
Five-minute Apgar
5-Minute Apgar Score Components: The 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: 1. Appearance (skin color) * 0: Blue or pale all over. * 1: Body pink, but extremities blue. * 2: Entire body pink. 2. Pulse (heart rate) * 0: No heartbeat. * 1: Fewer than 100 beats per minute. * 2: At least 100 beats per minute. 3. Grimace (reflex irritability, response to stimulation) * 0: No response to stimulation. * 1: Grimace or weak response when stimulated. * 2: Strong cry or active withdrawal in response to stimulation. 4. Activity (muscle tone) * 0: Limp, no movement. * 1: Some flexion of extremities. * 2: Active movement. 5. Respiration (breathing effort) * 0: Not breathing. * 1: Weak or irregular breathing. * 2: Strong cry, normal breathing.
Time frame: Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery
Rate of NICU Admission
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.
Time frame: In the first 24 hours after delivery.
Rate of Neonatal death
Neonatal death refers to the death of a newborn within the first 28 days of life. This period is further divided into two phases: * Early neonatal death: Neonatal death within the first 7 days of life. * Late neonatal death: Neonatal death occurring between 7 and 28 days of life.
Time frame: Within the first 28 days of life
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Plan to share: No
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Universidad Panamericana