NCT07050615

Brief Summary

Post-operative pain is the most prevalent issue following an episiotomy, greatly affecting patients both physically and mentally, resulting in increased morbidity. This study seeks to compare the effectiveness of continuous and interrupted suturing techniques for episiotomy post-operative pain among the local population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 25, 2025

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Post-operative pain (yes/no) was noted using the visual analogue scale (VAS).

    48 hours

Study Arms (2)

Continuous group

EXPERIMENTAL

In this group patients under going episiotomy, went through continuous suturing

Procedure: Continuous suturing

Interrupted group

EXPERIMENTAL

In this group patients under going episiotomy, went through interrupted suturing

Procedure: Interrupted suturing

Interventions

In this group, episiotomy repair was done using the continuous suturing.

Continuous group

In this group, episiotomy repair was done using the interrupted suturing.

Interrupted group

Eligibility Criteria

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

You may qualify if:

  • Pregnant females
  • Aged 20-40years
  • Undergoing an episiotomy to facilitate the delivery of the head in the labor room
  • First or second pregnancy
  • Gestational age of 37-41+6 weeks

You may not qualify if:

  • Females, undergone an instrumental vaginal delivery
  • With a history of previous perineal surgery
  • With high-risk pregnancies (those having hypertension, anemia or bleeding tendency, diabetes mellitus, a suspected genital infection)
  • With impaired immunity
  • Taking corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahida Islam Medical Complex

Lodhran, Punjab Province, 59320, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Arooj Akram

    Shahida Islam Medical Complex, Lodhran

    PRINCIPAL INVESTIGATOR
  • Joveria Sadaf

    Shahida Islam Medical Complex, Lodhran

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

August 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations