CTRI/2020/12/029925
Completed
Phase 4
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
Healthium Medtech Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated delivery
- Sponsor
- Healthium Medtech Pvt Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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