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Completed

NCT Number: NCT06978049

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Andrew Hospital

Constanța, Constanța County, 900184, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Lactic Acid Gel (BAYER)

Drug

Lactic acid gel, applied topically once daily to the episiotomy site, starting on postpartum day 7 for a total of seven consecutive days. Commercial product: BAYER (Bucharest, Romania).

Primary outcomes

  1. Episiotomy Wound Healing Score at 40 Days Postpartum

    Time frame: 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 outcomes

  1. Increase in Quality of Sexual Life

    Time frame: 40 days postpartum

    Healing outcomes and sexual quality of life wIll be assessed 40 days postpartum using a 12-item questionnaire.

Sponsors and collaborators

Lead sponsor

Saint Andrew Hospital Constanta

Other

Collaborators

  • Ovidius University of Constanta

Registry information

Acronym: LA30051990

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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