Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad Panamericana
- Enrollment
- 2
- Primary Endpoint
- Number of episiotomies performed
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Behavioral intervention
The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies.
Intervention: Feedback and information (Behavioral)
Standard of care
The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals.
Outcomes
Primary Outcomes
Number of episiotomies performed
Time Frame: During spontaneous or assisted vaginal delivery
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).
Secondary Outcomes
- Hematocrit after delivery(Within 24 hours after delivery)
- 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)
- Pain management after delivery(Administered in the first 24 hours after vaginal delivery)
- Patient satisfaction with the inpatient care received during and after vaginal delivery(Within the first 24 hours after delivery.)
- Rate of surgical site infection(In the first 6 weeks after vaginal delivery)
- Rate of NICU Admission(In the first 24 hours after delivery.)
- Rate of surgical site dehiscence(In the first 6 weeks after vaginal delivery)
- Five-minute Apgar(Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery)
- Rate of Neonatal death(Within the first 28 days of life)
Investigators
Mario I. Lumbreras-Marquez, MD, MMSc
Professor, Public Health and Epidemiology Department
Universidad Panamericana