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

Protocol summary

Summary
The objective of this study was to evaluate the continuous and interrupted methods for repair of episiotomy following childbirth, regarding the incidence of pain and wound repair. This randomized double blind clinical trial was carried out at 29 bahman and talegani hospital of Tabriz between January 2012 and February 2012 A total of 100 (50 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, non locking 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 12-18 hours postpartum and10th postpartum days. Wound repaire was evaluated by REEDA instrument consisted of edema, ecchymosis, redness, discharge, approximation,at 12-18 hours and10th days after birth.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112198459N1
Registration date: 2012-01-15, 1390/10/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences and Health Services.
Expected recruitment start date
2012-01-10, 1390/10/20
Expected recruitment end date
2012-02-19, 1390/11/30
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 wound repair
Public title
continuous versus interrupted sutures for episiotomy repair
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy, primiparus with vertex presentation and NVD inTabriz 29 bahman and talegani hospital, normal BMI,delivery with 3-4 cm length of episiotomy, without anemia and cronic diseases and no severe hemmorhage after delivery. Exclusion criteria: prolong rapture of membrane, prolong second stage, operative vaginal delivery (vacuum or forceps use), analgesic drug used 4 hours before pain measurement, immunosuppressive disease, use of immunosuppressive drug, smoking, systemic disease, 3rd or 4th degree perineal tear,coitus befor 10th day after delivery,perineal manipulation after episiotomy repair.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 tabriz University of Medical Sciences and Health Services
Street address
Tabriz University of Medical Sciences and Health Services
City
tabriz
Postal code
Approval date
2011-11-26, 1390/09/05
Ethics committee reference number
9054

Health conditions studied

1

Description of health condition studied
spontaneous vertex delivery
ICD-10 code
080.0
ICD-10 code description
spontaneous vertex delivery

Primary outcomes

1

Description
perineal pain
Timepoint
12-18 houres after delivery and 10th days
Method of measurement
visual analog scale

Secondary outcomes

1

Description
wound repair
Timepoint
12-18 hours and 10th days after birth
Method of measurement
REEDA scale

Intervention groups

1

Description
continuous repair of episiotomy in intervention group
Category
Other

2

Description
and interrupted repair of episiotomy in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
29 bahman hospital
Full name of responsible person
shahgoli roodabeh
Street address
29 bahman Ave
City
tabriz

2

Recruitment center
Name of recruitment center
Talegani hospital
Full name of responsible person
shahgoli roodabeh
Street address
Rahahan square
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
tabriz medical scince university- nursing and midwifery faculty
Full name of responsible person
hasanoor shirin
Street address
South Shariaty Ave . Tabriz nursung and midwifery faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tabriz medical scince university- nursing and midwifery faculty
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
Tabriz Nursing and Midwifery Faculty
Full name of responsible person
Hasanpoor shirin
Position
Academic member/midwifery MSc
Other areas of specialty/work
Street address
South shariaty Ave. Tabriz Nursing and Midwifery Faculty
City
Tabriz
Postal code
Phone
+98 41 1478 1497
Fax
+98 41 1478 1496
Email
hasanpoorsh@tbzmed.ac.ir shirinhasanpoor@yahoo.com rshahgoli@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Nursing and Midwifery Faculty
Full name of responsible person
Hasanpoor Shirin
Position
Midwifery MSc
Other areas of specialty/work
Street address
South Shariaty Ave . Tabriz Nursing and Midwifery Faculty
City
Tabriz
Postal code
Phone
+98 41 1478 1497
Fax
+98 41 1478 1496
Email
hasanpoorsh@tbzmed.ac.ir shirinhasanpoor@yahoo.com rshahgoli@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Nursing and Midwifery Faculty
Full name of responsible person
Hasanpoor Shirin
Position
Midwifery MSc
Other areas of specialty/work
Street address
South Shariaty Ave. Tabriz Nursing and Midwifery Faculty
City
Tabriz
Postal code
Phone
+98 41 1478 1497
Fax
+98 41 1478 1496
Email
hasanpoorsh@tbzmed.ac.ir shirinhasanpoor@yahoo.com rshahgoli@yahoo.com
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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