Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use

Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study

This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.

Study Overview

• Status: Not yet recruiting
• Conditions: Episiotomy; Episiotomy Wound; Episiotomy Extended by Laceration; Episiotomy Infection
• Intervention / Treatment: Behavioral: Feedback and information

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario I Lumbreras-Marquez, MD, MMSc; Phone Number: 5695 +52 55 54821600; Email: mlumbreras@up.edu.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.

Exclusion Criteria:

• Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral intervention; The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies.	Behavioral: Feedback and information; 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.
No Intervention: Standard of care; The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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: Appearance (skin color)0: Blue or pale all over.1: Body pink, but extremities blue.2: Entire body pink.; Pulse (heart rate)0: No heartbeat.1: Fewer than 100 beats per minute.2: At least 100 beats per minute.; 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.; Activity (muscle tone)0: Limp, no movement.1: Some flexion of extremities.2: Active movement.; Respiration (breathing effort)0: Not breathing.1: Weak or irregular breathing.2: Strong cry, normal breathing.	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: 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.	Within the first 28 days of life

Collaborators and Investigators

• Sponsor: Universidad Panamericana
• Collaborators: Universidad de la Salud - UNISA; IMSS-Bienestar; Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 101 - 101 - 001 - 24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No