Protocol summary

Summary
The main goal of the study is: evaluating the effect of vaginal cleansing with betadine before cesarean delivery on postoperative infectious morbidity in women with premature rupture of the membranes. The specific goals of the study are to compare fever, endometritis, and infectious morbidity related to the surgical wound between the two group with and without cleansing with betadine. The use of the study is to use this method if it would be effective. 100 pregnant women candidate of non-emergent cesarean section with premature rupture of membrane are randomly divided into two equal intervention and control groups. All patients are undergone cesarean section with phanensteil and kerr incision. Then the follow up of the patients will be done weekly to two weeks after cesarean and all the study variables will be evaluated with each visit. The two groups will be identical about age parity, gravidity, the time from the beginning of ruptured membrane. In the beginning, the following person will be unaware of the groups of the patients. inclusion criteria: history of ruptured membrane; candidates of cesarean with phanenshteil incision; those who have no more than two vaginal examinations. exclusion criteria: allergy to betadine; chorioamnionitis; active genital herpes; emergency cesareans; more than two vaginal examinations; more than 12 hours past the ruptured membranes; more than 1.5 hours duration of the operation. After randomization of patients into two groups, in the interventional group, the vagina is rinsed with 10% betadine for 30 seconds just before cesarean. In the control group nothing is done. All the patients are given 1g cephazoline before cesarean and 6 hour later for prophylaxis. They are followed weakly for two weeks. All the variables including, age; parity; gravidity; the interval from the ruptured membrane; fever(temperature=or>38 degree, 24 hours after delivery; endometritis(uterus tenderness with fever, requiring antibiotics; wound complications(including dehiscence, infection requiring antibiotics, debridement) will be evaluated with each visit.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111055485N2
Registration date: 2011-12-07, 1390/09/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-07, 1390/09/16
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Women's Reproductive Health Research Center, Tabriz University of Medical sciences
Expected recruitment start date
2010-12-10, 1389/09/19
Expected recruitment end date
2011-12-03, 1390/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal cleansing with betadine before cesarean delivery on postoperative infectious morbidity in women with premature rupture of the membranes
Public title
The effect of vaginal cleansing with betadine before cesarean delivery on postoperative infections in premature rupture of the membranes
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: history of ruptured membrane; candidates of cesarean with phanenshteil incision; those who have no more than two vaginal examinations. exclusion criteria: allergy to betadine; chorioamninitis; active genital herpes; emergency cesareans; more than two vaginal examinations; more than 12 hours past the ruptured membranes; more than 1.5 hours duration of the operation.
Age
From 16 years old to 48 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 350
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
Ethics Committee of Tabriz University of Medical Scienses
Street address
Research Deputy of Tabriz University of Medical Scienses, University of Tabriz, Golgasht street
City
Tabriz
Postal code
Approval date
2011-07-12, 1390/04/21
Ethics committee reference number
5/4/3152

Health conditions studied

1

Description of health condition studied
fever
ICD-10 code
O86.0, O86
ICD-10 code description
Infection of obstetric surgical wound , Infected: * caesarean section wound; Other infection of genital tract following delivery

Primary outcomes

1

Description
fever
Timepoint
before the operation, and 24 hours, one and two week after the operation
Method of measurement
sublingual termometer

2

Description
endometritis
Timepoint
the end of first and second week
Method of measurement
physical examination

3

Description
wound related complications
Timepoint
the end of first and second week
Method of measurement
physical examination

Secondary outcomes

1

Description
infectious complication of the newborn
Timepoint
one day after and one and two weeks after cesarean
Method of measurement
diagnosis of neonatologists registered

2

Description
allergy to betadine
Timepoint
the day after cesarean
Method of measurement
the day after cesarean

Intervention groups

1

Description
In the intervention group, before scrubbing, the vagina will be rinsed with 10% betadine, with a sterile gloved hand.
Category
Prevention

2

Description
In the control group, the cleansing of the vagina will not be done.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra and Talegani Hospital
Full name of responsible person
Nazli Navali
Street address
Talegani Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Women's Reproductive Health Research Center, Tabriz University of Medi
Full name of responsible person
dr.Elahe Saheb Olad Madarec
Street address
Artesh street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Women's Reproductive Health Research Center, Tabriz University of Medi
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 University of Medical Scienses
Full name of responsible person
Nazli Navali
Position
assistent professor/bord certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
59, Sahand street, Emam khomeyni avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1334 5416
Fax
Email
navalin@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Scienses
Full name of responsible person
Nazli Navali
Position
assistent professor/bord certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
59, Sahand street, Emam khomeyni avenue
City
Tabriz
Postal code
Phone
+98 41 1330 2879
Fax
Email
navalin@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Scienses
Full name of responsible person
Nazli Navali
Position
assistent professor/bord certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
59, Sahand street, Emam khomeyni avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1330 2879
Fax
Email
navalin@tbzmed.ac.ir
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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