Comparison of early maternal complications of episiotomy repair in Continious versus interrupted suturing technique in the primiparous women referring to Niknafs maternity hospital, Rafsanjan 2016-2017
This study is a prospective clinical trial that comparing early maternal complications of episiotomy repair in continuous versus interrupted suturing technique in the primiparous women. 140 pregnant women that have Conditions for entry into the study (term Pregnancy (37-42 weeks), singleton pregnancy, vertex presentation, 18-35 years old, BMI <30, non labour dystocia, non large episiotomy, non Instrumental delivery) will randomly divided into two groups ech group 70 persons. Group one episiotomy will repair in continuous method and interrupted method in another group. Early maternal complications such as perineal pain and wound healing Will be reviewed at 2 hours after delivery, 3-5 days after delivery, 2 weeks after delivery and 6 weeks after delivery. The results will be announced after completing the sampling and data analyzes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090635617N1
Registration date:2017-09-06, 1396/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
pouran Allahbakhshi nasab
Name of organization / entity
Rafsanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0097
Email address
p.allahbakhshi96@gmail.com
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early maternal complications of episiotomy repair in Continious versus interrupted suturing technique in the primiparous women referring to Niknafs maternity hospital, Rafsanjan 2016-2017
Public title
Comparing episiotomy repair with interrupted method and continuous method.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy(37-42); singleton pregnancy; cephalic presentation; 18-35 years old primiparous; BMI <30.
Exclusion criteria: special diet; special disease (anemia, cardiovascular disease, diabetes, immunity disease, liver disease, depression, coagulation disorders, preeclapcia, infectious diseases); smoking; alcoholism, narcotic drugs, labour dystosia; large episiotomy; postpartum hemorrhage; vacium; forceps; constant constipation; sever pain and hematoma; fever and chills after childbirth; 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:
140
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
Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd.
City
Rafsanjan
Postal code
7717933777
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR. RUMS.REC.1396.90
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Perinel pain
Timepoint
2 hours, 3-5 days, 2 weeks and 6 weeks after delivery
Method of measurement
Visual analog scale
2
Description
Wound infection
Timepoint
2 hours, 3-5 days, 2 weeks and 6 weeks after delivery
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Uncomfortable stitches
Timepoint
2 houres, 3-5 days, 2 weekes and 6 weekes after delivery
Method of measurement
Survey
2
Description
Use of analgesia
Timepoint
2 houres, 3-5 dayes, 2 weekes and 6 weekes after delivery
Method of measurement
Questionnaire
3
Description
Episiotomy repaire time
Timepoint
2 houres, 3-5 dayes, 2 weekes and 6 weeks after delivery
Method of measurement
Timing
4
Description
Number of pockets
Timepoint
2 houres, 3-5 days, 2 weekes and 6 weekes after delivery
Method of measurement
Counting
Intervention groups
1
Description
intervention group: episiotomy will be repaired with continious method in four layers: vegina, muscle,sub cutaneous and skin without cutting sutures.
Category
Prevention
2
Description
control group: episiotomy will be repaired with interrupted method in four layers in the way vegina continious lockin, muscle interrupted, sub cotaneous continious and skin interrupted.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Niknafs maternity hospital
Full name of responsible person
Allahbakhshinasab pouran
Street address
Rafsanjan- shohada street
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Allahbakhshinasab Pouran
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd.
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan Faculty of Nursing and Midwifery
Full name of responsible person
Allahbakhshinasab Pouran
Position
Master of Midwifery / Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jomhoori Blvd.
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
parastari@rums.ac.ir
Web page address
www.nm.rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan Faculty of Nursing and Midwifery
Full name of responsible person
Allahbakhshinasab Pouran
Position
Master of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jomhoori Blvd.
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
parastari@rums.ac.ir
Web page address
www.nm.rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan Faculty of Nursing and Midwifery
Full name of responsible person
Allahbakhshinasab Pouran
Position
Master of midwifery/ Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jomhoori Blvd.
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
parastari@rums.ac.ir
Web page address
www.nm.rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)