Episiotomy, Postpartum Period, Wound Healing
Conditions
Keywords
Episiotomy, Wound Healing, Postpartum
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.
Interventions
DRUGTopical 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).
Sponsors
Ovidius University of Constanta
Saint Andrew Hospital Constanta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Romania
Outcome results
None listed