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A study to compare two different suture materials in episiotomy repair

A PROSPECTIVE COMPARATIVE RANDOMISED SINGLE BLINDED STUDY OF POLYGLACTIN-910 SUTURE VERSUS CATGUT SUTURE IN EPISIOTOMY REPAIR

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033103
Enrollment
116
Registered
2021-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Trusynth fast Polyglactin-910 fast absorbable suture: Fast absorbable suture used for suturing the episiotomy wound and suture will not be removed once applied Control Intervention1: Tr

Sponsors

BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women aged 18-35 years, with a singleton pregnancy undergoing vaginal delivery with episiotomy 2. Women who have given informed written consent 3. Women with gestational age of 37 completed weeks.

Exclusion criteria

Exclusion criteria: 1. Women administered with epidural labor analgesia 2. Women whose membranes had ruptured for >24hrs 3. Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies 4. Women who had a previous perineal surgery other than the primary repair after child birth 5. AIDS, hepatitis – B, Chronic disease 6. Local vaginal or vulval infection 7. Women with bleeding/coagulation disorders/intrapartum fever 8. Women who has delivered a dead fetus 9. Women with severe anemia and uncontrolled diabetes, Obesity & malnutrition

Design outcomes

Primary

MeasureTime frame
Subjective assessment of perineal pain following episiotomy repairTimepoint: Day 0, Day 2, Day 11, Week 12, Week 24

Secondary

MeasureTime frame
1. To evaluate tissue reaction in both the groups 2. To evaluate the wound healing in both the groups 3. To evaluate resumption of sexual activity and dyspareunia in both the groups 4. To evaluate suture parameters 5. To evaluate suture related complications post-episiotomy repairTimepoint: Day 0, Day 2, Day 11, Week 12, Week 24

Countries

India

Contacts

Public ContactTANYA

BGS GIMS

srikanthroopa@yahoo.com9880715085

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026