Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort

Not Applicable

Completed

• Conditions: Episiotomy; Wound Healing; Postpartum Period
• Interventions: Drug: Topical Lactic Acid Gel (BAYER)

• Registration Number: NCT06978049
• Lead Sponsor: Saint Andrew Hospital Constanta

Brief Summary

This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.

Detailed Description

This prospective controlled clinical study aims to evaluate the efficacy of topical lactic acid gel in promoting the healing of episiotomy wounds and improving postpartum sexual quality of life.

The study was conducted at the County Clinical Emergency Hospital "Sf. Ap. Andrei" in Constanța, Romania, between February 1, 2023, and December 31, 2024, with ethical approvals obtained from both the Ethics Committee of Ovidius University of Constanța (No. 01/20.01.2023) and the Saint Andrew Hospital Ethics Committee (No. 7230/31.01.2023).

A total of 100 postpartum women aged 18 to 40 years, who underwent spontaneous vaginal delivery with mediolateral episiotomy at a gestational age of 38-40 weeks, were enrolled in the study after providing informed consent. Participants were sequentially assigned into two parallel groups:

Experimental Group (n = 50): Received topical lactic acid gel (commercially available formulation from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site, starting seven days postpartum, for a total duration of seven consecutive days.

Control Group (n = 50): Received standard postpartum care without additional topical treatments, allowing for spontaneous healing of the episiotomy wound.

The primary endpoint was the assessment of episiotomy wound healing quality at 40 days postpartum, determined via visual inspection and healing scoring. The secondary endpoint was the evaluation of postpartum sexual function, assessed using a validated 12-item sexual quality of life questionnaire specifically designed for postpartum women. The questionnaire addressed domains including sexual desire, orgasm frequency, sexual satisfaction, pain during intercourse (dyspareunia), vaginal dryness, emotional well-being during intercourse, and partner-related factors. Higher total scores reflected better sexual health and satisfaction.

Study Timeline

• Study Start: 2023-01-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women aged 18-40 years
• Spontaneous vaginal delivery with mediolateral episiotomy at 38-40 weeks gestation
• No pre-existing wound healing disorders or infections
• Provided informed consent

Exclusion Criteria

• Known hypersensitivity to lactic acid products
• Third- or fourth-degree perineal tears
• Gestational diabetes or immunosuppressive conditions
• Use of additional wound care treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canesbalance Group	Topical Lactic Acid Gel (BAYER)	Participants in this group received topical lactic acid gel (a commercial product from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site. Treatment began on day 7 postpartum and continued for seven consecutive days.

Primary Outcome Measures

Name	Time	Method
Episiotomy Wound Healing Score at 40 Days Postpartum	40 days postpartum	Evaluation of the quality of episiotomy wound healing, assessed through visual inspection and clinical scoring at 40 days postpartum. Higher scores reflect better wound healing. Healing assessment was performed by the clinical care team using a standardized evaluation system to ensure consistency across participants.

Secondary Outcome Measures

Name	Time	Method
Increase in Quality of Sexual Life	40 days postpartum	Healing outcomes and sexual quality of life wIll be assessed 40 days postpartum using a 12-item questionnaire.

Trial Locations

Locations (1)

Saint Andrew Hospital; 🇷🇴 Constanta, Romania