Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Panamericana
About this trial
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.
Disqualifiers
Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.
Trial design
Design model
Parallel
Treatments tested in this trial
Feedback and information
BehavioralThe 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.
Treatment groups
2 Participants
are divided into 2 treatment groupsGroup A: Behavioral interventionExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 deliverySecondary outcomes
1
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 delivery2
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 delivery3
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 delivery4
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 deliveryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Panamericana
Lead sponsor
Universidad de la Salud - UNISA
Collaborator
IMSS-Bienestar
Collaborator
Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México
Collaborator
Source ClinicalTrials.gov
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