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Comparison of Continuous Versus Interrupted Sutures For Episiotomy Repair on Perineal Pain And Infection

Protocol summary

Summary
The objective of this study was to compare continuous versus interrupted sutures for repair of episiotomy following childbirth, regarding the incidence of pain and wound infection. This randomized double blind clinical trial was carried out at Hajar hospital of Shahrecord between September 2008 and July 2009. A total of 148 (74 in each group) healthy women who had undergone vaginal deliveries with episiotomies were allocated to undergone episiotomy using continuous or interrupted suture techniques. In the first group, the incision was repaired with continuous, nonlocking sutures involving the vagina, perineal muscles, subcutaneous, and skin tissues. In the other group the incision was repaired with continuous, locking sutures of the vagina and subcutaneous, interrupted sutures in the perineal muscles and skin. Frequency and degree of pain were evaluated by visual analog scale at 2 hours postpartum and10th and 40th postpartum days. Wound infection was evaluated by edema, ecchymosis, hyperemia, secretion, dehiscence, and fibrosis at 10th days after birth.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806162427N1
Registration date: 2010-06-04, 1389/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-04, 1389/03/14
Registrant information
Name
Manigeh Sereshti
Name of organization / entity
Shahrecord University of Medical Sciences and Health Services- Nursing and Midwifery faculty-Midwife
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
m_sereshti@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrecord University of Medical Sciences and Health Services
Expected recruitment start date
2007-08-23, 1386/06/01
Expected recruitment end date
2009-06-21, 1388/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Continuous Versus Interrupted Sutures For Episiotomy Repair on Perineal Pain And Infection
Public title
Continuous versus interrupted sutures for episiotomy repair
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: singelton pregnancy with vertex presentation and Occipital anterior position, shahrecord resident Exclusion criteria: prolong rapture of membrane, prolong second stage, operative vaginal delivery (vaccum or forceps use), analgesic drug used 4-6 hours before pain measurement, immunosuppressanive disease, use of immunosuppressive drug, smoking, systemic disease, 3rd or 4th degree perineal rupture
Age
From 14 years old to 41 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Shahrecord University of Medical Sciences and Health Services
Street address
Vice Chancellor for Research, Shahrecord University of Medical Sciences and Health Services, Kashani Street, Shahrecord
City
Shahrecord
Postal code
Approval date
2007-08-01, 1386/05/10
Ethics committee reference number
86-6-9

Health conditions studied

1

Description of health condition studied
Spontaneous vertex delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Perineal Pain
Timepoint
At 2 hours postpartum and 10th and 40th days after birth
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Episiotomy Wound Infection
Timepoint
10th days after birth
Method of measurement
Wound infection was evaluated by edema, ecchymosis, hyperemia, secretion, dehiscence, fibrosis

Intervention groups

1

Description
Continuous Episiotomy Repair
Category
Prevention

2

Description
Standard Episiotomy Repair or Interrupted Sutures For Repair Of Episiotomy
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrecord Hajar Hospital
Full name of responsible person
Manijeh Sereshti
Street address
Shahrecord-Nurse Street-Shahrecord Hajar Hospital
City
Shahrecord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrecord University of Medical Sciences and Health Services
Full name of responsible person
Manije Sereshti
Street address
Vice Chancellor for Research, Shahrecord University of Medical Sciences and Health Services, Kashani Street, Shahrecord
City
Shahrecord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrecord University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrecord University of Medical Sciences and Health Services
Full name of responsible person
Manijeh Sereshti
Position
Faculty member/ Midwifery Msc
Other areas of specialty/work
Street address
Midwifery department, Nursing and Midwifery Faculty, Shahrecord University of Medical Sciences and Health Services, Rahmateah, Shahrecord
City
Shahrecord
Postal code
Phone
+98 38 1333 5648
Fax
Email
M_Sereshti@yahoo.com M_Sereshti@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrecord University of Medical Sciences and Health Services
Full name of responsible person
Manijeh Sereshti
Position
Faculty member/ Midwifery Msc
Other areas of specialty/work
Street address
Midwifery department, Nursing and Midwifery Faculty, Shahrecord University of Medical Sciences and Health Services, Rahmateah, Shahrecord
City
Shahrecord
Postal code
Phone
+98 38 1333 5648
Fax
Email
M_Sereshti@yahoo.com M_Sereshti@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrecord University of Medical Sciences and Health Services
Full name of responsible person
Manijeh Sereshti
Position
Faculty member/ Midwifery Msc
Other areas of specialty/work
Street address
Midwifery department, Nursing and Midwifery Faculty, Shahrecord University of Medical Sciences and Health Services, Rahmateah, Shahrecord
City
Shahrecord
Postal code
Phone
+98 38 1333 5648
Fax
Email
M_Sereshti@yahoo.com M_Sereshti@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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