Comparison Between Treatment With Gauze Soaked With Cold Magnesium Sulfate Solution Against Gauze Soaked With Cold Water for Treatment of Perineal Swelling Following Vaginal Delivery - A Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 206
- 试验地点
- 3
- 主要终点
- Reduction in perineal swelling
研究概览
简要总结
The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.
Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water.
Nurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times.
A physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such.
A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded.
Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment.
Period of follow-up will be 48-72 hours from childbirth.
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
- •parturients following normal vaginal birth or vacuum-assisted vaginal delivery
- •reporting of perineal pain equal to or greater than 3 on a 0-10 scale
排除标准
- •parturients following cesarean section
- •lack of consent to take part in the study
- •parturients interested in early discharge (within 48 hours of childbirth)
- •girls under 18 years of age
结局指标
主要结局
Reduction in perineal swelling
时间窗: 3 days
Reduction in the level of perineal pain
时间窗: 3 days
次要结局
- Reduction in hemorrhoids pain and swelling(3 days)