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| Name | Class |
|---|---|
| Universidad de la Salud - UNISA | UNKNOWN |
| IMSS-Bienestar | UNKNOWN |
| SecretarÃa de Educación, Ciencia, TecnologÃa e Innovación de la Ciudad de México | UNKNOWN |
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This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral intervention | Experimental | The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies. |
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| Standard of care | No Intervention | The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback and information | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During spontaneous or assisted vaginal delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario I Lumbreras-Marquez, MD, MMSc | Contact | +52 55 54821600 | 5695 | mlumbreras@up.edu.mx |
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Two hospitals (clusters) will be assigned to intervention and standard of care.
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| 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. | 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. | 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 | Administered in the first 24 hours after delivery |
| Blood loss at the time of delivery | Estimated or calculated blood loss (mL). | Within the first hour after spontaneous or assisted vaginal delivery |
| Hematocrit after delivery | Percentage (%) of red blood cells (RBCs) in the total blood volume. | Within 24 hours after delivery |
| Pain management after delivery | Description of Nonsteroidal Antiinflammatory Drugs and Opioids administered | 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. | 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. | 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). | 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:
| 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. | 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:
| Within the first 28 days of life |