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The effect of amniotic membrane on cesarean wound healing in womans who refered to gerash medical and educational center in 2014

Protocol summary

Summary
Objective: To determine the effect of dressing by amniotic membrane on the cesarean wound healing. Methods: This study is a prospective randomized double-blind clinical trial. Patients participating in the study were women who undergoing cesarean section in Amir-al-Momenin hospital of Gerash, Iran.The inclusion criteria include:(1) Term pregnancy (42-37 weeks), (2) Body mass index (BMI) greater than 29, (3) Willingness to participate in the study, (4) No complications of pregnancy (eclampsia, placenta previa, placenta abruption, multiple birth, Corioamniotitis, meconium defecation, poly Hydroamnios), (5) No history of any known disease with affect to wound healing, (6) Not having any Abnrmality in the fetus and infants hospitalized to the NICU, (7) No major bleeding or need for blood transfusion, hysterectomy or myomectomy,(8) No smoking, alcohol and drugs, (9) No preoperative rupture of membrane, (10) The lack of meconium defecation,(11) No history of cesarean section more than two time. Women were excluded from the study if: the operation prolonged for more than 90 minutes, or patient did not refer to the hospital 8 days after surgery. Patients were divided into two groups (N=45 for each group). In one group, the wound was dressing by amniotic membrane and in the control group dressing was done by simple dressing. The wound healing was assessed by REEDA scale 24 hours and 8 days after cesarean.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014010616110N1
Registration date: 2014-04-30, 1393/02/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-30, 1393/02/10
Registrant information
Name
Fatemeh Mohseni
Name of organization / entity
Shiraz University of Medical Sciences, Nnursing & Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
mohseni_f@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of amniotic membrane on cesarean wound healing in womans who refered to gerash medical and educational center in 2014
Public title
The effect of amniotic membrane on cesarean wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy (42-37 weeks); Body mass index (BMI) greater than 29; willingness to participate in the study; no complications of pregnancy (eclampsia, placenta previa, placental abruption, twin pregnancy, Corioamniotitis, meconium defecation, poly Hydroamnios); no history of any known disease with affect to wound healing; not having any abnormality in the fetus and infants hospitalized to the NICU; no major bleeding or need for blood transfusion, hysterectomy or myomectomy; no smoking, alcohol and drugs; no rupture of membrane; the lack of meconium defecation; no history of cesarean section more than two time. Exclusion criteria: prolonged operation for more than 90 minutes; no referral 8 days after surgery.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand street,shiraz
City
Shiraz
Postal code
14336 - 71348
Approval date
2014-04-15, 1393/01/26
Ethics committee reference number
93-6993

Health conditions studied

1

Description of health condition studied
Cesarean
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
Wound healing
Timepoint
24 hours after intervention and 8 day after intervention
Method of measurement
REEDA scale

Secondary outcomes

empty

Intervention groups

1

Description
In this procedure, the amniotic membrane was separated from placenta using of sterile gloves by gynecologist. Thus after washing with normal saline and cleaning membrane from blood and clot, the amniotic membrane was placed on the wound of surgery in the experimental groups. To prevent rapid drying of membrane a wet sterile gauze with saline was placed on it and then wound was dressed by a few dry gauze.
Category
Treatment - Other

2

Description
In the control group dressing was done by dry gauze.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir-al-Momenin Gerash Medical and Educational Center
Full name of responsible person
Mohseni Fatemeh
Street address
amir-al-momenin medical and educational center,emam khomeini street,gerash,fars
City
Gerash

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seied Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand street,shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Molazem Zahra
Position
assistant professor
Other areas of specialty/work
Street address
fatemeh (p.b.u.h) school of nursing & midwifery,shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
molazemzah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Molazem Zahra
Position
Assistant professor
Other areas of specialty/work
Street address
fatemeh (p.b.u.h) school of nursing & midwifery,shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
molazemzah@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Mohseni
Position
Graduate nurse
Other areas of specialty/work
Street address
fatemeh (p.b.u.h) school of nursing & midwifery,shiraz
City
Shiraz
Postal code
13119–71936
Phone
+98 71 1647 4254
Fax
+98 71 1647 4252
Email
khademianm@sums.ac.ir
Web page address
nurs-midwif.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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