CClinicalTrials.gg
CompletedNCT07073131Updated Jul 18, 2025

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

An interventional study of Vicryl Rapide suturing and Chromic catgut suturing in Episiotomy Extended by Laceration and Episiotomy Wound, sponsored by Huma Ijaz. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Huma Ijaz · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Episiotomy Extended by Laceration
  • Episiotomy Wound

Keywords

  • Episiotomy
  • Pain
  • Wound Infection
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 202 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

This is the only study on the registry with Huma Ijaz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
202 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Vicryl Rapide suturing

  • Active comparator
    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.

    Other: Chromic catgut suturing

Interventions

  • OtherVicryl Rapide suturing

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

  • OtherChromic catgut suturing

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

  2. Post surgical pain

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

    Time frame: 7 days

  3. 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.

    Time frame: 7 days

07

Study locations

1 site
  • CMH Gujranwala
    Guiranwala, Punjab Province 52230, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07073131
Lead sponsor
Huma Ijaz
Responsible party
Huma Ijaz (Dr Huma Ijaz, Combined Military Hospital Gujranwala) — Sponsor-investigator
First posted
Jul 18, 2025
Start date
Jul 1, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jul 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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