Not yet recruiting NCT06625866
Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feedback and information.
- Who it may be relevant to
- Registry conditions: Episiotomy, Episiotomy Extended by Laceration, Episiotomy Infection, Episiotomy Wound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study
Overview
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
Interventions
- 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 w
Primary outcome measures
- Number of episiotomies performed [Time frame: During spontaneous or assisted vaginal delivery]
Secondary outcome measures (12)
- Episiotomy indication documented in the medical record [Time frame: During spontaneous or assisted vaginal delivery]
- Number of assisted vaginal deliveries [Time frame: At the time of vaginal delivery]
- Number of perineal and cervical lacerations (composite outcome) [Time frame: At the time of spontaneous or assisted vaginal delivery]
- Rate of transfusion of blood products (composite outcome) [Time frame: Administered in the first 24 hours after delivery]
- Blood loss at the time of delivery [Time frame: Within the first hour after spontaneous or assisted vaginal delivery]
- Hematocrit after delivery [Time frame: Within 24 hours after delivery]
- Pain management after delivery [Time frame: Administered in the first 24 hours after vaginal delivery]
- Patient satisfaction with the inpatient care received during and after vaginal delivery [Time frame: Within the first 24 hours after delivery.]
- Rate of surgical site infection [Time frame: In the first 6 weeks after vaginal delivery]
- Rate of surgical site dehiscence [Time frame: In the first 6 weeks after vaginal delivery]
- Five-minute Apgar [Time frame: Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery]
- Rate of NICU Admission [Time frame: In the first 24 hours after delivery.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06625866 · 101 - 101 - 001 - 24