Protocol summary

Summary
Objective: Comparison of some outcomes of two techniques for expansion of the low transverse uterine incision at cesarean section Design: Clinical Trial, Single blind, Control with standard technic of surgery, Unicenter Population: All women who are candidate for cesarean section Inclusion criteria: All women with singleton pregnancy and term gestational age who give informed constsnt for our research Exclusion criteria: Unknown gestational age, preterm or postterm pregnancy, placenta previa, abruptio placenta, severe hemorrhage before cesarean section, polyhydramnios, connective tissue disorders, estimated fetal weight greater than 4000 gr, uterine atony during or after cesarean section Interventions: Transverse and cephalad cauded blunt expansion of the low transverse uterine incision at cesarean section Main outcome measures: Unwanted extension of uterine incision, Need to blood transfusion, Assessment of intraoperation blood loss At first data form including name, age, gravidity, gestational age, and indication of cesarean section will be completed for all participants .Then they will be assigned to blunt expansion of the uterine incision with transverse traction or cephalad cauded group by quad blocks. Hematocrit will be assessed just before and 6 hours after operation. Surgery will be done under general or spinal anesthesia (based on indication) and all operative procedures will be performed similarly before the uterine incision . A transverse uterine incision in the uterine segment of 1 to 2 cm will be expanded by the designated method. In case group, opening of the lower uterine segment will be created by separation of the index fingers of the surgeon in a cephalad cauded direction along the midline but in the control group the incision will be extended by lateral and upward pressure applied with index fingers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051533989N1
Registration date: 2017-06-09, 1396/03/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Minoo Yaghmaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2590
Email address
m.yaghmaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-04-03, 1390/01/14
Expected recruitment end date
2012-04-02, 1391/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of some outcomes of two techniques for expansion of the low transverse uterine incision at cesarean section
Public title
Expansion of the low transverse uterine incision at cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All women with singleton pregnancy, gestational age between 37 to 42 weeks who are candidate for elective or emergency cesarean section and give informed constsnt for our research. Exclusion criteria: Unknown gestational age, preterm or postterm pregnancy, placenta previa, abruptio placenta, severe hemorrhage before cesarean section,BMI greater than 30, polyhydramnios, connective tissue disorders, estimated fetal weight greater than 4000 gr, uterine atony during or after cesarean section
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 288
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
zahedan University of Medical Sciences
Street address
Dr. Hessabi sq. khalije Fars Blv.
City
Zahedan
Postal code
Approval date
2011-02-23, 1389/12/04
Ethics committee reference number
89-3678

Health conditions studied

1

Description of health condition studied
Cesarean
ICD-10 code
082
ICD-10 code description
Single delivery by caesarean section

Primary outcomes

1

Description
Unwanted extension of uterine incision to cervix, vagina, upper segment of uterus with need to additional sutures
Timepoint
Just after intervention
Method of measurement
Yes or no with evaluator assessment

2

Description
Need to additional sutures for control of bleeding of uterine incision after repair of that
Timepoint
Just after intervention
Method of measurement
yes or no with evaluator assessment

3

Description
Need to blood transfusion
Timepoint
After intervention
Method of measurement
Yes or no with evaluator assessment

4

Description
More than 10% Hb decrease after cesarean section
Timepoint
After intervention
Method of measurement
Yes or no with medical record assessment

5

Description
Assessment of intraoperation blood loss
Timepoint
Just after intervention
Method of measurement
Assessment by evaluator / mili liter

Secondary outcomes

empty

Intervention groups

1

Description
Case group: After making an incision of 2 cm on lower segment, uterine will be extended in vertical direction to uterine incision with the index fingers.
Category
Treatment - Surgery

2

Description
Control group: After making an incision of 2 cm on lower segment, uterine will be extended in lateral and upward direction with the index fingers.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Aiiebneabitaleb hospital
Full name of responsible person
Mojgan Mokhtari
Street address
Zahedan- Dr Hesabi square
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Sagheb
Street address
Dr Hesabi Sq, Zahedan
City
Zahedan
Grant name
__________
Grant code / Reference number
________
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mojgan Mokhtari
Position
Obstetrics & Gynecology faculty
Other areas of specialty/work
Street address
Aliebne Abitaleb Hospital, Hesabi Sq, Zahedan
City
Zahedan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
mmokhtari1345@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mojgam Mokhtari
Position
Obstetrics & Gynecology faculty
Other areas of specialty/work
Street address
Aliebne Abitaleb Hospital, Dr Hesabi Sq, Zahedan
City
Zahedan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
Email
mmokhtari1345@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Yaghmaei
Position
Obstetrics & Gynecology faculty
Other areas of specialty/work
Street address
Taleghani Hospital, Arabi Street, Daneshjoo Blv, Evin, Tehran
City
Tehran
Postal code
1985717413
Phone
Fax
Email
yaghmaeim@yahoo.comm.yaghmaei@sbmu.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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