1-Goals: Selecting procedure which is associated with minimal complications
2:The study population:Women with a history of more than twotimes cesarean section, candidate for elective Cesarean in Alzahra university Hospital Tabriz
3:Study Designe:Randomized, double-blind
contral trial 4- Sample:42 patients with Maylard or vertical section group
Intervention 5-Primary outcome measurement: amount of Bleeding, infection,Wound dehiscence severity of pain,Satisfaction from work, based on the need for blood transfusions and mumber blood gas phase , characterized abdominal incision.In postoperative mothers, the need for analgetics, , and the severity of pain will be determined.
Inclusion criteria:Term pregnancy;. history of cesarean section in term pregnancy for more than 2 times; not having an underlying disease such as diabetes or lupus;. not having severe preeclampsia;.no prolonged rupture of membranes (PROM)>= 12 hours, having no oprative bleeding;. Morbid obesity.
Exclusion craitria:Midwifery bleeding during surgery ;. including the atonic uterus and placenta acreta ;. placenta percreta ;. need to hysterectomy or ovariectomy ;. need for further explorationduring surgery an underlying disease leading tofutherbleeding ;. such as coagulative disease .Emergency case of midwifery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102211205N1
Registration date:2013-04-22, 1392/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-22, 1392/02/02
Registrant information
Name
Dr.Zahra Fardiazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
fardiazar@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short-term outcomes of two vertical incision in the abdomen and Millard in pregnant women with a previous two time cesarean surgery.
Public title
Comparison of short-term outcomes of two vertical incision in the abdomen and Millard in pregnant women with a previous two time cesarean surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Term pregnancy;. history of cesarean section in term pregnancy for more than 2 times; not having an underlying disease such as diabetes or lupus;. not having severe preeclampsia;.no prolonged rupture of membranes (PROM)>= 12 hours, having no oprative bleeding;. Morbid obesity.
Exclusion craitria:Midwifery bleeding during surgery ;. including the atonic uterus and placenta acreta ;. placenta percreta ;. need to hysterectomy or ovariectomy ;. need for further explorationduring surgery an underlying disease leading tofutherbleeding ;. such as coagulative disease .Emergency case of midwifery.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Ssciences, Golgasht avenue
City
Tabriz
Postal code
5138665793
Approval date
2012-10-29, 1391/08/08
Ethics committee reference number
7237/4/5
Health conditions studied
1
Description of health condition studied
Vertical incision and Millard in Pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding
Timepoint
At the end of the abdominal incision
Method of measurement
Using the site of action of counting gases
Secondary outcomes
1
Description
Time to move the patient lying down, sitting or walking
Timepoint
Every day until discharge
Method of measurement
Tolerable and intolerable pain and need medication and onset of breastfeeding to infants
2
Description
pain scor
Timepoint
Every 4 hours after surgery until discharge
Method of measurement
Using visual analog scale
Intervention groups
1
Description
Abdominal vertical incision in 42 patients
Category
Prevention
2
Description
Millard procedure in 42 patients
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr.Zahra Fardiazar
Street address
Alzahra hospital, Artesh jonoobi avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Scienes
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
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,Tabriz University of Medical Scienes
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 Sciences
Full name of responsible person
Dr.Zahra Fardiazar
Position
Associate
Other areas of specialty/work
Street address
South Artesh Street Bagh shomal Crossroads Alzahra Hospital