NCT03611452

Brief Summary

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing. The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 25, 2018

Last Update Submit

August 1, 2018

Conditions

Episiotomy Wound

Outcome Measures

Primary Outcomes (1)

  • the mean score of Perineal pain during vaginal suturing

    assessment through visual analog scale score from 0 - 10 at every step of repair

    10 minutes

Study Arms (3)

Simple continuous

EXPERIMENTAL

the sutures will be taken continuously by simple method

Procedure: Episiotomy

subcuticular

ACTIVE COMPARATOR

the sutures will be taken subcuticular

Procedure: Episiotomy

interrupted

ACTIVE COMPARATOR

the sutures will be taken interrupted method

Procedure: Episiotomy

Interventions

EpisiotomyPROCEDURE

repair of perineal muscles and skin

Simple continuousinterruptedsubcuticular

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal vaginal delivery.
  • At term (37 40 weeks ).
  • Live baby.
  • Vertex presentation

You may not qualify if:

  • Third and fourth degree perineal tear.
  • Instrumental vaginal delivery.
  • Previous perineal surgery.
  • Anaemia with hemoglobin level \< 9 g/dl.
  • Diabetes mellitus.
  • Coagulation abnormalities.
  • Postpartum hemorrhage.
  • Delivery conducted outside Woman HealthHospital.
  • Breech delivery.
  • Body mass index \>35 kg/m2.
  • Local infectious lesions.
  • Anal fissures or hemorrhoid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Episiotomy

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 2, 2018

Study Start

August 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

August 2, 2018

Record last verified: 2018-08