The main objective of this study is comparing the effects of heparin with enoxaparin in patients after cesarean section.
This is a double blind clinical trial on 176 women undergoing cesarean section.
Inclusion criteria: The ones who have two of these criteria: age over 35, BMI more than 30, multiparty, preeclampsia, postpartum hemorrhage, emergency cesarean and hysterectomy.
Exclusion criteria: patient's discontent, risk of wound infection (diabetes, Chorioamnionitis and long-lasting rupture of the amniotic sac)
The subjects are divided into two groups randomly, using simple randomization by means of draw. One group will receive heparin and the other one is given enoxaparin. The patients, the practitioner who gives the drugs and the one responsible for documenting the data are blind to the administered drug. Heparin is given 5000 unit twice daily for 7 to 12 days after surgery. Enoxaparin is prescribed 24 hours following surgery, 40 mg daily for 7 to 10 days. Then the incidence of the signs of deep vein thrombosis, pulmonary emboli and side effects (infection and hematoma) are measured. Wound examination will be done for 10 days following cesarean. The obtained data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031427042N1
Registration date:2016-04-13, 1395/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-13, 1395/01/25
Registrant information
Name
ZOHREH SALARI
Name of organization / entity
KERMAN UNIVERSITY OF MEDICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 2250
Email address
z_salari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
KERMAN UNIVERSITY OF MEDICAL SCIENCES
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effects of heparin with enoxaparin in patients undergoing cesarean section
Public title
The comparison of the side effects of heparin and enoxaparin in patient with cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The ones who have two of these criteria: age over 35, BMI more than 30, multiparty, preeclampsia, postpartum hemorrhage, emergency cesarean and hysterectomy.
Exclusion criteria: patient's discontent, risk of wound infection (diabetes, Chorioamnionitis and long-lasting rupture of the amniotic sac)
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
176
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 Kerman University Medical Sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2015-12-23, 1394/10/02
Ethics committee reference number
IR.KMU.afrc.REC.1394.2
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Formation of thrombosis in deep veins
Timepoint
During hospital stay period
Method of measurement
Clinical examination and Doppler sonography
2
Description
Formation of pulmonary embolus
Timepoint
During hospital stay period
Method of measurement
Clinical examination and CT scan
Secondary outcomes
1
Description
formation of hematoma
Timepoint
for 10 days after surgery
Method of measurement
wound examination
2
Description
wound infection
Timepoint
for 10 days after surgery
Method of measurement
wound examination
Intervention groups
1
Description
In intervention group Heparin is given 5000 unit, SC twice daily for 7 to 12 days after surgery
Category
Treatment - Drugs
2
Description
In control group Anoxaparin is prescribed 24 hours following surgery, 40 mg, SC daily for 7 to 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Zohre Salari
Street address
Zendan Square
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zohre Salari
Position
gynecologist
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
KERMAN
Postal code
Phone
+98 34 3223 5011
Fax
Email
zohreh_salari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeede Salari
Position
Medical Student
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
saeede.salari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeede Salari
Position
Medical Student
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
saeede.salari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)