Comparison of neonatal and maternal outcomes associated with head-pushing and head-pulling methods for impacted fetal head extraction during cesarean delivery
Design
A clinical trial, with two intervention and control groups, One blind,randomized,70 patients who are candidates for cesarean section will be included in this study
Settings and conduct
After the approval of the Ethics Committee of the Vice-Chancellor of Research of Tabriz University of Medical Sciences and registering at IRCT and obtaining consent from patients. 70 women with term pregnancy that they are candidates for cesarean section because of the onset of descending during labor.The patient will not be aware of which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All women with singleton pregnancy and term gestational age who have fallen in the active phase of labor and give informed constant for our research.
The exclusion criteria :multiple pregnancies; previous cesarean delivery;
fetal anomalies and premature delivery.
Intervention groups
In the intervention group(35 people), an assistant helped to dislodge the head vaginally, and the surgeon delivered the dislodged head through the uterine incision; the rest of the fetus was delivered via routine cesarean techniques. In the pull (reverse breech) group, the surgeon inserted their hand toward the upper segment of the uterus and searched for the fetal leg; gentle traction was then applied until the second leg appeared. While holding both legs, the surgeon gently pulled the fetus up and out of the uterus through the uterine incision—similar to an assisted vaginal breech delivery.
In the control group(35 people), the surgeon will try, take out the embryo, without doing dysluch. If the removal of the fetus during the above process is not possible, then the head pushing method will be used.
Main outcome variables
Newborn apgar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038879N2
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Fatemeh Abbasalizadehf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
abbasalizadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-30, 1397/02/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of prophylactic dislodge with routine cesarean indescending arrest
Public title
Comparison of two methods of prophylactic dislodge with routine cesarean indescending arrest
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete cervical dilatation
Arrest descent for more than an hour
The position of the fetus in a positive state of one
Exclusion criteria:
Multiple pregnancies
cesarean history
Embryonic abnormalities
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with using a random number table based on the case number, will be randomly assigned into two intervention and control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
For all 70 patients, the study process will be explained, but the patients will not know which group will be studied.
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
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.TBZMED.REC.1397.014
Health conditions studied
1
Description of health condition studied
Single delivery by cesarean section
ICD-10 code
082
ICD-10 code description
Single delivery by cesarean section
Primary outcomes
1
Description
Prevalence of fever in the mother
Timepoint
4 hours after delivery until discharge
Method of measurement
Thermometer
Secondary outcomes
1
Description
Apgar
Timepoint
Immediately after birth
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: The patient is placed in the lithotomy and after the transverse section of the lower segment of the womb by the surgeon and before acting to remove the head of the embryo, with the help of the surgeon, pressing on the head will be prophylactic in all cases. The surgeon will help the surgeon to push The head of the embryo is placed between the legs of the patient and with a zero degree of degree of pressure on the head of the embryo to a degree that causes displacement of the head of the fetus.
Category
Treatment - Other
2
Description
Control group: Dislodge will not be used unless the surgeon recognizes it.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fatemeh Abbasalizadeh
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Abbasalizadeh
Position
Professor Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available