Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use

NCT06625866 | Not Yet Recruiting

• 1 other identifier: 101 - 101 - 001 - 24
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Episiotomy; Episiotomy Extended by Laceration; Episiotomy Infection; Episiotomy Wound

Outcome Measures

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).

  During spontaneous or assisted vaginal delivery

Secondary Outcomes (13)

• Episiotomy indication documented in the medical record

  During spontaneous or assisted vaginal delivery

• Number of assisted vaginal deliveries

  At the time of vaginal delivery

• Number of perineal and cervical lacerations (composite outcome)

  At the time of spontaneous or assisted vaginal delivery

• Rate of transfusion of blood products (composite outcome)

  Administered in the first 24 hours after delivery

• Blood loss at the time of delivery

  Within the first hour after spontaneous or assisted vaginal delivery

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies.

Behavioral: Feedback and information

Standard of care

NO INTERVENTION

The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals.

Interventions

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.

Behavioral intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Central Study Contacts

Mario I Lumbreras-Marquez, MD, MMSc

CONTACT

+52 55 54821600; mlumbreras@up.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Public Health and Epidemiology Department

Model Details: Two hospitals (clusters) will be assigned to intervention and standard of care.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share