Continuous Versus Discontinuous Suture in the Perineals Lesions Produced During Delivery in Primiparous: Maternal Results: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Analogical scale of pain
研究概览
简要总结
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were followed-up as follows: Day of childbirth and in the postpartum period.
详细描述
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques. Group A received continuous sutures and Group B had interrupted sutures placed. The women were allocated to a treatment group using a computer-generated random numbers table. The sequence was placed in individual opaque envelopes that were opened when a woman met the inclusion criteria.
The health personnel that carry out the sutures had taken a training course on continuous suture technique and had at least one year experience in this technique. Additionally, this person had a minimum of five years of experience in attending deliveries and therefore also in the suturing of perineal lesions. The sutures were placed by ten trained midwives. Around 5% of the midwives in Torrecardenas, 10% in the Hospital Complex of Jaen, 12% in Granada, and 20% of the midwives in Ubeda and Linares participated.
Data collection Data was collected on sociodemographic variables, type of perineal trauma (tear of second-degree or episiotomy), type of suture used, time spent placing suture, number of suture packets used, complications, analogical scale of pain, type of pain, need for analgesia, wound condition, care performed, urinary and/or fecal incontinence, start of sexual relations, start of physical activity and type of newborn feeding. It was also collected the start and type of delivery, medication during dilation, type of analgesia used, gestational week, duration of dilation, second stage labor and delivery, and data on the newborn.
Information was gathered by midwives which interviewed the women in the labor room, providing them with an informed consent form, and hiding the suture technique that was going to be used. The rest of the data were obtained from the clinical history, maternal record book and phone calls made for the follow-up. The women did not know at any point which suture technique had been used.
Follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Primiparous
- •Singleton and eutocic delivery
- •Second-degree perineal tear or an episiotomy as part of labor
- •Newborn weight between 2500 g and 4000 g
排除标准
- •Language barrier (to no speak spanish)
- •Problems related to the pelvic floor prior to labor (prolapse, incontinence, vulva varices)
- •Dyspareunia or sexual dysfunction
- •Hemorrhoids perceived as uncomfortable or painful
研究组 & 干预措施
Continuous suture
All parts of the perineal lesion (vaginal mucosa , perineal muscle and skin) be sutured with the same suture thread. A single suture for perineal lesion
干预措施: Continuous suture in the perineals lesions (Procedure)
Discontinuous suture
Interrupted suture technique: vaginal mucosa, perineal muscle and skin are sutured with separate and different threads, that is, the vaginal mucosa is sutured with a thread, then independently the perineal muscle is sutured with another type of thread and finally the skin is also sutured independently with another different thread. Three independent sutures for each of the parts that form a single perineal lesion
干预措施: Discontinuous suture in the perineals lesions (Procedure)
结局指标
主要结局
Analogical scale of pain
时间窗: After delivery was done at two hours
It consists of a line horizontal 10 centimeters, at the ends of which are the extreme expressions of a symptom In the left is the absence or less intensity and in the right the greater intensity
Numerical verbal scale for pain
时间窗: After delivery was done at three months.
Scale numbered 1-10, where 0 is the absence and 10 the highest intensity, the patient selects the number that best assesses the intensity of the symptom.
次要结局
- Questionnaire(After delivery was done three months.)
- Questionnaire on Women Sexual Function (WSF)(After delivery was done at three months.)
研究者
Juan Miguel Martinez-Galiano
Principal Investigator
University of Jaén