Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Perineal pain intensity according to NRS scale at the day after treatment initiation
研究概览
简要总结
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.
In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.
Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman after spontaneous or operative vaginal delivery
- •Perineal pain score of at least 2 NRS
排除标准
- •Women after cesarean delivery
- •Refuse to participate
- •Under 18 years of age
- •Magnesium sulfate treatment not related to the study
- •Contraindication for magnesium sulfate treatment
- •Workers of the local obstetric department
研究组 & 干预措施
Pads with cold magnesium sulfate 33% solution
干预措施: Magnesium sulfate 33% solution (Drug)
Pads with cold water
干预措施: Cold water (Other)
结局指标
主要结局
Perineal pain intensity according to NRS scale at the day after treatment initiation
时间窗: 24 hours post enrollment
Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
时间窗: 24 hours post enrollment
次要结局
- Perineal pain intensity according to NRS scale two days after treatment initiation(2 days (if still in hospital))
- Degree of perineal healing using the REEDA scale(2 days)
- Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids(2 days)