Clinical trial NCT06978049: Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
Official title: Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy
Wound Healing
Postpartum Period
Keywords: Episiotomy
Wound Healing
Postpartum
Lead sponsor: Saint Andrew Hospital Constanta
Sponsor class: OTHER
Collaborators: name: Ovidius University of Constanta
First posted: 2025-05-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Episiotomy Wound Healing Score at 40 Days Postpartum
timeFrame: 40 days postpartum
Secondary outcomes:
measure: Increase in Quality of Sexual Life
timeFrame: 40 days postpartum
Other outcomes:
Locations:
city: Constanta
country: Romania
facility: Saint Andrew Hospital
Study officials:
References: