NCT07572617

Brief Summary

There is paucity of local literature regarding the most appropriate absorbable suture material for episiotomy repair despite the fact that tremendous number of women undergo the procedure daily. Hence, the current study was planned aiming to compare the outcome between absorbable synthetic and catgut suture material in episiotomy repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Post-operative pain

    Pain was measured on the visual analog scale, with 0 as no pain, 1-3 as mild, 4-7 as moderate, and 8-10 as severe pain. Frequencies of all categories were noted.

    6 weeks

  • Wound infection

    The frequency of patients developing a wound infection was noted.

    6 weeks

  • Wound dehiscence

    The frequency of patients who experienced episiotomy wound ruptures and opened up along a surgical incision was noted.

    6 weeks

Study Arms (2)

Group-A

EXPERIMENTAL

Patients went through suturing with absorbable synthetic suture.

Procedure: Absorbable synthetic suture

Group-B

EXPERIMENTAL

Patients went through suturing with catgut.

Procedure: Catgut

Interventions

Patients went through suturing with absorbable synthetic suture.

Group-A
CatgutPROCEDURE

Patients went through suturing with catgut.

Group-B

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women
  • Aged 20-40 years
  • Gestational age 37-42 weeks (assessed on last menstrual period)

You may not qualify if:

  • Premature rupture of membranes
  • Preterm vaginal delivery
  • Twin gestation
  • Operative delivery
  • Vulval hematoma
  • Vaginal tears

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadiq Abbasi Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Interventions

Catgut

Intervention Hierarchy (Ancestors)

SuturesSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Komal Iqbal

    Sadiq Abbasi Hospital, Bahawalpur, Pakistan

    PRINCIPAL INVESTIGATOR
  • Saba Nadeem, FCPS

    Sadiq Abbasi Hospital, Bahawalpur, Pakistan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

March 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations