Protocol summary

Summary
This study is a randomised clinical trial that assessment early maternal morbidity from episiotomy repair with choromic catgut and rapid vicryl.One hundred primiparous women with episiotomy, term gestational age, no specific disease, spontaneous delivery, no labour dystocioa and no macrosomia randomly allocated to repair with either, rapid vicryl or choromic catgut(50 each).A group: Choromic catgut. B group: Rapid vicryl. The outcom wich will assessed is perineal pain that measure with a visual analog scale and episiotomy healing that will measured with reeda scale at 24 hours, 3-5 days, 2 weeks and 6 weeks after postpartum.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061818135N1
Registration date: 2014-08-02, 1393/05/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
pouran allahbakhshi nasab
Name of organization / entity
Shiaz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4253
Email address
allahbakhshi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early maternal complications of episiotomy repair with Rapid vicryl and chromic catgut in the primiparous women
Public title
Comparison of early maternal complications of episiotomy repair with Rapid vicryl and chromic catgut in the primiparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy; singleton; Vertex presentation; Age 18-35 years; primiparous; no special diet; lack of specific diseases (anemia, cardiovascular disease, diabetes, immune disorders, liver disease, depression, lack of clotting disorders, preeclampsia and Infectious Diseases); non smoking, alcohol and drugs; BMI less than 27 Exclusion criteria: disorder of delivery (prolonged labor and dystocia steps); extention of episiotomy; heavy bleeding after delivery (over 500 cc); use Vacium; further manipulating the perineum after childbirth; persistent constipation after childbirth; a serious and long-lasting pain after delivery; hematoma; fever and chills after delivery; macrosomia
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Ave, Imam Hossein Square, Shiraz, Iran
City
Shiraz
Postal code
1978 - 71345
Approval date
2014-04-23, 1393/02/03
Ethics committee reference number
7001 -93

Health conditions studied

1

Description of health condition studied
Episiotomy repaire
ICD-10 code
090. 1
ICD-10 code description
Infection of obstetric surgical wound

Primary outcomes

1

Description
Chromic catgut
Timepoint
24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum
Method of measurement
Qualitative

2

Description
Rapid vicryl
Timepoint
24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum
Method of measurement
Qualitative

Secondary outcomes

1

Description
Wound healing
Timepoint
24 hours, 3-5 days, 2 weeks, 6 weeks poste partume
Method of measurement
Reeda scale

2

Description
Perineal pain
Timepoint
24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum
Method of measurement
Visual analog scale

Intervention groups

1

Description
IN intervention group episiotomy repaired with rapid vicryl then aerly maternal morbidity including perineal pain assessment whith visual analog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum. Then the incidens of complications compaired with control group.
Category
Prevention

2

Description
In control group episiotomy repaired with choromic catgut then early maternal morbidity including perineal pain assessment with visual anaiog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum. Then the incidens of complications compaired with intervention group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Niknafs maternity hospital, Rafsanjan
Full name of responsible person
Pouran allahbakhshi nasab
Street address
Niknafs maternity hospital, shohada avenue, Rafsanjan, Iran
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Sara azima
Street address
Centeral bilding of medical sciences, Zand avenue, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Pouran allahbakhshi nasab
Position
Master student
Other areas of specialty/work
Street address
Centeral bilding , Zand avenue, Shiraz, Iran
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1455 0235
Fax
+98 71 1455 0235
Email
allahbakhshi@sums.ac.ir
Web page address
wwww.sums.c.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Sara azima
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Iran
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1647 4252
Fax
Email
azimas@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of Medical Sciences
Full name of responsible person
Pouran allahbakhshi nasab
Position
Master student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Iran
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1647 4252
Fax
Email
Allahbakhshi@sums.ac.ir
Web page address
www.sums.ac.ir

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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