Single blind, randomized comparative study assessing clinical equivalence of two polyglycolic acid fast absorbing suture brands, Truglyde FastÃ?Â® and Safil QuickÃ?Â®, on maternal morbidity experienced by women following episiotomy repair

Healthium Medtech Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Women aged 18-40 years, with a singleton pregnancy
•2. Primiparous or multiparous women who will require episiotomy during the course of vaginal delivery
•3. Women with gestational age of >34 weeks
•4. Women with good systemic/ mental health as per opinion of investigator
•5. Women who have given informed consent

•1. Women with intrapartum fever and history of bleeding/coagulation disorders
•2. Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies
•3. Women who had a previous perineal surgery other than the primary repair after child birth
•4. Women with known HIV or the hepatitis B infection
•5. Women who has delivered a dead fetus
•6. Women having any known allergy to the suture materials
•7. Women already participating in another trial
•8. Women unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of investigator
•9. Other indication-based exclusion, in the opinion of investigator

发起方

Healthium Medtech Pvt Ltd