NCT07453979

Brief Summary

Although the postpartum period is generally considered a positive experience, obstetric interventions such as episiotomy may lead to significant maternal health problems. Episiotomy, a surgical incision performed on the perineum during the second stage of labor, remains widely used despite World Health Organization recommendations to limit its rate. Episiotomy-related complications, including pain, infection, bleeding, and dyspareunia, can negatively affect wound healing, quality of life, and postpartum sexual health. Proper episiotomy wound care and education are therefore essential components of postpartum care. This study aims to evaluate the effect of an artificial intelligence-supported video education on episiotomy wound healing and postpartum sexual quality of life. The findings are expected to contribute to improved postpartum care practices and guide future research in this field.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

December 19, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 19, 2025

Last Update Submit

March 5, 2026

Conditions

Keywords

EpisiotomyPostpartum CareArtificial IntelligenceWound HealingSexual Quality of Life

Outcome Measures

Primary Outcomes (3)

  • (REEDA Scale)

    Episiotomy wound healing will be evaluated using the REEDA Scale, which assesses five components: redness, edema, ecchymosis, discharge, and approximation of wound edges.

    Postpartum Day 1, Day 3, Day 5, Day 7, and Day 14

  • Episiotomy wound healing score (REEDA Scale)

    Episiotomy wound healing will be assessed using the REEDA Scale, which evaluates five components: redness, edema, ecchymosis, discharge, and approximation of wound edges

    Postpartum day 1, day 3, day 5, day 7, and day 14

  • Perineal pain intensity (Visual Analog Scale - VAS)

    Perineal pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will indicate their perceived pain intensity on the scale.

    Postpartum day 1, day 3, day 5, day 7, and day 14

Secondary Outcomes (1)

  • Postpartum sexual function and dyspareunia score (Carol Postpartum Sexual Function and Dyspareunia Scale)

    Postpartum 3 months after resumption of vaginal intercourse

Study Arms (2)

INTERVENTION 1

EXPERIMENTAL

Women allocated to the intervention group will receive an AI-assisted video-based educational intervention on episiotomy care in addition to routine postpartum care.

Behavioral: AI-Assisted Episiotomy Care Video Group

Control

OTHER

Routine postpartum care

Other: Control

Interventions

ControlOTHER

Women in the control group will receive routine postpartum and episiotomy care provided by midwives before discharge, in accordance with standard hospital practices. No additional educational or AI-assisted video intervention will be provided to this group.

Control

Women in the intervention group will receive routine postpartum care and an AI-assisted educational video about effective breastfeeding within the first 30 minutes after birth. The video includes information on the importance of early breastfeeding, correct breastfeeding positions, and techniques to increase milk production.

INTERVENTION 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age and older,
  • No high-risk pregnancy (no systemic disease, no smoking, no postpartum complications),
  • Gestational age 37-42 weeks,
  • Single vaginal delivery of live birth,
  • Mediolateral episiotomy,
  • Not taking any medication,
  • No other lacerations besides episiotomy (anal sphincter injury, 3rd degree perineal laceration).
  • Single vaginal delivery of live birth or single vaginal delivery without episiotomy, age between 18-35 years, sexually active and healthy
  • Primiparous pregnant women

You may not qualify if:

  • Mothers who have had multiple, stillbirth, or anomalous births,
  • Mothers who refuse home visits will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant Prof dr

Study Record Dates

First Submitted

December 19, 2025

First Posted

March 6, 2026

Study Start

April 2, 2026

Primary Completion

May 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share