NCT07073131

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 9, 2025

Last Update Submit

July 9, 2025

Conditions

Episiotomy Extended by LacerationEpisiotomy Wound

Keywords

EpisiotomyPainWound Infection

Outcome Measures

Primary Outcomes (3)

  • Wound dehiscence

    Wound dehiscence was labeled if there was partial or total separation of previously approximated wound edges, due to a failure of proper wound healing within 7 days of episiotomy.

    7 days

  • Post surgical pain

    After 24 hours of episiotomy participants were examined for pain score by using visual analogue scale.

    7 days

  • Wound Infection

    Wound infection was labeled if participant developed pain and pus discharge at wound site, along with fever (\>100F) within 7 days of episiotomy.

    7 days

Study Arms (2)

Participants with Vicryl Rapide suturing

ACTIVE COMPARATOR

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.

Other: Vicryl Rapide suturing

Participants with chromic catgut suturing

ACTIVE COMPARATOR

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.

Other: Chromic catgut suturing

Interventions

Vicryl Rapide suturingOTHER

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

Participants with Vicryl Rapide suturing
Chromic catgut suturingOTHER

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

Participants with chromic catgut suturing

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Gujranwala

Gujranwala, Punjab Province, 52230, Pakistan

Location

MeSH Terms

Conditions

PainWound Infection

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Huma Ijaz

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

July 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)