Comparison Between Maternal Complications of Chromic Catgut and Vicryl Rapid Sutures Used for Episiotomy Repair

NCT ID: NCT07073131

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

Brief Summary

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Total 202 patients fulfilling the selection criteria were enrolled from labor room and underwent episiotomy. At end of procedure, females were randomly divided in two groups. In group A, females underwent suturing by using vicryl rapide. In group B, females underwent suturing by using chromic catgut. After 24 hours of delivery, females were examined for pain score. After 7 days, females were examined for wound infection, inflammation and dehiscence. All this information was recorded in proforma.

Detailed Description

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Conditions

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Episiotomy Extended by Laceration Episiotomy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Participants with Vicryl Rapide suturing

After approval from ethical review board (ERC letter no: 37-2024 dated 10-01-2024), 202 females fulfilling the selection criteria were enrolled from labor room. Informed consent was taken. Demographics were noted. Then participants underwent episiotomy. At end of procedure, they were randomly divided in two groups by using lottery method. Group A includes 101 participants that underwent suturing by using vicryl rapide. After 24 hours they were examined for pain score by using visual analogue scale. They were discharged after examining the episiotomy wound and were followed-up for 7 days in OPD. During follow-up, participants were examined for pain score, wound infection, inflammation and dehiscence.

Group Type ACTIVE_COMPARATOR

Vicryl Rapide suturing

Intervention Type OTHER

Post episiotomy vicryl rapide suturing material is used for stitching episiotomy laceration.

Participants with chromic catgut suturing

Total 202 females fulfilling the selection criteria were enrolled from labor room. Informed consent was taken. Demographics were noted. Then participants underwent episiotomy. At end of procedure, they were randomly divided in two groups by using lottery method. Group B included 101 participants that underwent suturing by using chromic catgut. After 24 hours they were examined for pain score by using visual analogue scale. They were discharged after examining the episiotomy wound and were followed-up for 7 days in OPD. During follow-up, participants were examined for pain score, wound infection, inflammation and dehiscence.

Group Type ACTIVE_COMPARATOR

Chromic catgut suturing

Intervention Type OTHER

Post episiotomy chromic catgut suturing material is used for stitching episiotomy laceration

Interventions

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Vicryl Rapide suturing

Post episiotomy vicryl rapide suturing material is used for stitching episiotomy laceration.

Intervention Type OTHER

Chromic catgut suturing

Post episiotomy chromic catgut suturing material is used for stitching episiotomy laceration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primigravida of age 18-35 years
* Gestational age during 37-40 weeks

Exclusion Criteria

* Females with abnormal placenta, non-cephalic presentation, multiple fetus, premature rupture of membranes, unclean vaginal examination.
* pre-delivery hemoglobin \<9 g/dl,
* Manual removal of placenta
* Vulvar hematoma and vaginal tears
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Huma Ijaz

OTHER

Sponsor Role lead

Responsible Party

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Huma Ijaz

Dr Huma Ijaz

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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CMH Gujranwala

Chak One Hundred Seventy-five Nine Left, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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37

Identifier Type: -

Identifier Source: org_study_id

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