The objective of this study was to compare chromic catgut and vicryl sutures for repair of episiotomy following childbirth, regarding the incidence of pain and wound repair. This randomized controlled trial was carried out at Rasoul Akram hospital of Rasht between 2013 and 2014. A total of 102 (51 in each group) healthy women who had undergone vaginal deliveries with episiotomies were allocated to undergone episiotomy using chromic catgut or vicryl sutures. In the first group, the incision was repaired with vicryl sutures and in the other group the incision was repaired with chromic catgut. In both groups all the episiotomies were right mediolateral and were repaired by a standard three-step approach. The vaginal mucosa was repaired with continuous interlocking suture; the perineal muscle was sutured with intermittent suture and the skin closure was done with mattress suture. Frequency and degree of pain were evaluated by visual analog scale at 12-24 hours and one week postpartum days. Wound repair was evaluated by REEDA instrument consisted of edema, ecchymosis, redness, discharge, approximation,at 12-24 hours and one week after birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030816897N1
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
maryam moridi
Name of organization / entity
Guilan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
maryammoridi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Chromic Catgut versus Vicryl Sutures for Episiotomy Repair on Perineal Pain and Wound Repair Outcomes
Public title
Chromic Catgut Versus Vicryl sutures for episiotomy repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 37-42week; singleton alive fetus; cephalic presentation; no surgical history in perinea and vagina; no chronic diseases; no infectious diseases or fever and no use of certain medications, such as glucocorticoids, anticoagulants, chemotherapy, immunosuppressant, radiation.
Exclusion criteria: disruptions in delivery (first stage more than 20 hours and Prolonged second stage more than 2 hour (prolonged labor) or cervical dilatation more than 5 cm/h or duration or labor less than 3 hours (precipitate labor)); third-or fourth-degree lacerations; spontaneous laceration in perinea; vaginal laceration; cervical laceration; hematoma in the first hours after delivery and delivery by assistance tools.
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:
102
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
Guilan University of Medical Sciences
Street address
Vice-chancellor for Research- Gaz Sq. Rasht- Guilan- Iran
City
Rast
Postal code
4193893345
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
2920422819
Health conditions studied
1
Description of health condition studied
Perineal laceration during delivery
ICD-10 code
070.0
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
perineal pain
Timepoint
12-24 hour and one week after delivery
Method of measurement
Visual Analogue scale
Secondary outcomes
1
Description
Wound repair outcomes
Timepoint
12-24 hours and one week after delivery
Method of measurement
REEDA scale
Intervention groups
1
Description
Repair of episiotomy with vicryl in intervention group
Category
Treatment - Surgery
2
Description
Repair of episiotomy with chromic catgut in control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Homira Nazifkar
Street address
Rasoul Akram Hospital- Rasht- Guilan- Iran
City
Rast
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Moridi
Street address
Vice-chancellor for Research- Gaz Sq. Rasht- Guilan- Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Maryam Moridi
Position
Instructor- Academic member
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Postal code
Phone
+98 13 1555 5056
Fax
Email
maryammoridi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Tahereh Ziaei
Position
Master science in midwifery
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Postal code
Phone
+98 13 1555 5056
Fax
Email
maryammoridi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Tahereh Ziaei
Position
Master science in midwifery- Academic member
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Postal code
Phone
+1 315555056
Fax
Email
maryammoridi@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)