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| ID | Type | Description | Link |
|---|---|---|---|
| 7230/31.01.2023 | Registry Identifier | Saint Andrew Hospital Ethical Comitee Registry |
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| Name | Class |
|---|---|
| Ovidius University of Constanta | OTHER |
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This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canesbalance Group | Experimental | 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. |
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| No Intervention Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Episiotomy Wound Healing Score at 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. | 40 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Quality of Sexual Life | Healing outcomes and sexual quality of life wIll be assessed 40 days postpartum using a 12-item questionnaire. | 40 days postpartum |
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Inclusion Criteria:
Exclusion Criteria:
Only postpartum women aged 18 to 40 years who have undergone spontaneous vaginal delivery with mediolateral episiotomy are eligible for inclusion in this study. Male participants are not eligible, as the study specifically investigates female perineal wound healing and postpartum sexual quality of life.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Andrew Hospital | Constanța | Constanța County | 900184 | Romania |
The study involves sensitive personal health information, including sexual function and postpartum recovery data, which are subject to strict confidentiality and privacy regulations. Participant consent for public data sharing was not obtained, and sharing of individual-level data may pose risks to participant anonymity. Only aggregate results will be reported in publications.
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