Single blind, randomized comparative study assessing clinical equivalence of two polyglactin 910 fast absorbing suture brands, Trusynth Fast® and Vicryl Rapide®, on maternal morbidity experienced by women following episiotomy repair
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast® and Vicryl Rapide®
研究概览
简要总结
Episiotomy is a surgical incision of the perineum (the area between the vaginal opening and back passage) to enlarge the vaginal opening during labor or delivery. This procedure is done with scissors or scalpel and requires repair by suturing. Polyglactin 910 fast-absorbing sutures are commonly used for episiotomy repair as it is associated with less perineal pain, analgesic use, infection and re-suturing. In this study, we plan to assess differences in maternal morbidity between two commonly used brands of polyglactin 910 fast-absorbing sutures, Trusynth Fast® and Vicryl rapide®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women aged 18-40 years, with a singleton pregnancy
- •Primiparous or multiparous women who will require episiotomy during the course of vaginal delivery
- •Women with gestational age of >34 weeks
- •Women with good systemic/ mental health as per opinion of investigator
- •Women who have given informed consent.
排除标准
- •Women with intrapartum fever and history of bleeding/coagulation disorders
- •Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies
- •Women who had a previous perineal surgery other than the primary repair after child birth
- •Women with known HIV or the hepatitis B infection
- •Women who has delivered a dead fetus
- •Women having any known allergy to the suture materials
- •Women already participating in another trial
- •Women unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of investigator
- •Other indication-based exclusion, in the opinion of investigator.
结局指标
主要结局
1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast® and Vicryl Rapide®
时间窗: Day 2, Day 11, Week 6 and Week 12
次要结局
- 1. To compare the use of analgesics in both the groups(2. To evaluate the wound healing in both the groups)
