Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
NCT ID: NCT06978049
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2023-01-31
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Canesbalance Group
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.
Topical Lactic Acid Gel (BAYER)
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).
No Intervention Group
Participants in this group received standard postpartum care without the addition of lactic acid gel or any other specific wound-healing treatments. Healing occurred spontaneously according to routine clinical practice.
No interventions assigned to this group
Interventions
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Topical Lactic Acid Gel (BAYER)
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).
Eligibility Criteria
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Inclusion Criteria
* Spontaneous vaginal delivery with mediolateral episiotomy at 38-40 weeks gestation
* No pre-existing wound healing disorders or infections
* Provided informed consent
Exclusion Criteria
* Third- or fourth-degree perineal tears
* Gestational diabetes or immunosuppressive conditions
* Use of additional wound care treatments
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ovidius University of Constanta
OTHER
Saint Andrew Hospital Constanta
OTHER
Responsible Party
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Brezeanu Dragos
Principal Investigator
Locations
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Saint Andrew Hospital
Constanța, Constanța County, Romania
Countries
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Other Identifiers
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7230/31.01.2023
Identifier Type: REGISTRY
Identifier Source: secondary_id
BD30051990
Identifier Type: -
Identifier Source: org_study_id
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