Episiotomy Extended by LacerationNCT07073131
Comparison Between Maternal Complications of Chromic Catgut and Vicryl Rapid Sutures Used for Episiotomy Repair
A study testing Vicryl Rapide suturing and Chromic catgut suturing in people with Episiotomy Extended by Laceration and Episiotomy Wound, run by Huma Ijaz at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Extended by Laceration, Episiotomy Wound
- What is being tested?
- Vicryl Rapide suturing and Chromic catgut suturing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravida of age 18-35 years
- Gestational age during 37-40 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH Gujranwala
Chak One Hundred Seventy-five Nine Left, Punjab Province, 52230
About this study
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.
- Being tested
- Vicryl Rapide suturing, Chromic catgut suturing
- Keywords
- Episiotomy, Pain, Wound Infection
- Medical subject headings
- Pain, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl Rapide suturingOther
Post episiotomy vicryl rapide suturing material is used for stitching episiotomy laceration.
Chromic catgut suturingOther
Post episiotomy chromic catgut suturing material is used for stitching episiotomy laceration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chromic catgut suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Post surgical pain
After 24 hours of episiotomy participants were examined for pain score by using visual analogue scale.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy Extended by LacerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huma Ijaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huma Ijaz, Combined Military Hospital Gujranwala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073131
- Sponsor's protocol ID
- 37
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Maternal Complications of Chromic Catgut and Vicryl Rapid Sutures Used for Episiotomy Repair
- ClinicalTrials.gov ID
- NCT07073131
- Acronym / sponsor ID
- 37
- Keywords
- Episiotomy, Pain, Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Huma IjazUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Vicryl Rapide suturing | Active comparator | Other: Vicryl Rapide suturingAfter 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. |
| Participants with chromic catgut suturing | Active comparator | Other: Chromic catgut suturingTotal 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primigravida of age 18-35 years
- Gestational age during 37-40 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vicryl Rapide suturingPost episiotomy vicryl rapide suturing material is used for stitching episiotomy laceration. | Other | Participants with Vicryl Rapide suturing |
| Chromic catgut suturingPost episiotomy chromic catgut suturing material is used for stitching episiotomy laceration | Other | Participants with chromic catgut suturing |
Primary outcome
Wound dehiscence
Time frame: 7 days
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.
Post surgical pain
Time frame: 7 days
After 24 hours of episiotomy participants were examined for pain score by using visual analogue scale.
Wound Infection
Time frame: 7 days
Wound infection was labeled if participant developed pain and pus discharge at wound site, along with fever (>100F) within 7 days of episiotomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Episiotomy Extended by Laceration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl Rapide suturing and Chromic catgut suturing in people with Episiotomy Extended by Laceration and Episiotomy Wound, run by Huma Ijaz at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound dehiscence (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.