Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Episiotomy Wound Healing Score at 40 Days Postpartum
研究概览
简要总结
This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Known hypersensitivity to lactic acid products
- •Third- or fourth-degree perineal tears
- •Gestational diabetes or immunosuppressive conditions
- •Use of additional wound care treatments
研究组 & 干预措施
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.
干预措施: Topical Lactic Acid Gel (BAYER) (Drug)
结局指标
主要结局
Episiotomy Wound Healing Score at 40 Days Postpartum
时间窗: 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.
次要结局
- Increase in Quality of Sexual Life(40 days postpartum)
研究者
Brezeanu Dragos
Principal Investigator
Ovidius University of Constanta