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Comparison of the maternal and neonatal fate of head removal between three methods of removing the head by the cephalic, breech, and anterior shoulder in the head deeply stuck in the pelvis

Protocol summary

Study aim
Comparison of maternal and neonatal complications of head removal between three methods of cephalic (push), pull (pull) and anterior shoulder resection in the head deeply stuck in the pelvis
Design
A clinical trial with three factorial groups on 111 people (three groups of 37 people) will use ANOVA test to compare quantitative variables between the three groups in case of normal distribution of data and Kruskal-Wallis test will be used otherwise.
Settings and conduct
In three groups of 37 people, in the first group, one fetus was removed by pushing the head and cephalic, in the second group, two fetuses were removed by pulling the legs and breeches, and in the third group, the anterior shoulder was removed. In three groups, the duration of surgery from skin incision to suturing, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine rupture, neonatal appendix, neonatal trauma, need for NICU hospitalization, and duration Wu's mother is hospitalized and compared. Location of Imam Reza Hospital
Participants/Inclusion and exclusion criteria
Complete Cervical effacement and Stop childbirth The head is stuck in the birth canal Station 1- or more
Intervention groups
In one group, the fetus is removed by pushing the head and cephalic, in one group, the fetus is removed by pulling the legs and breeches, and in the third method, by removing the anterior shoulder.
Main outcome variables
Duration of surgery, the extent of trauma to the bladder, trauma to the pelvic organs, volume of bleeding during cesarean section, an extension of uterine incision, involvement of uterine arteries, need for blood transfusion, length of hospital stay, apkarnozad, trauma to the baby's organs, need for hospitalization Infant NICU, duration of infant hospitalization

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101130005280N43
Registration date: 2021-11-30, 1400/09/09
Registration timing: registered_while_recruiting

Last update: 2021-11-30, 1400/09/09
Update count: 0
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the maternal and neonatal fate of head removal between three methods of removing the head by the cephalic, breech, and anterior shoulder in the head deeply stuck in the pelvis
Public title
Comparison of the maternal and neonatal fate
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Complete Cervical effacement and Stop childbirth The head is stuck in the birth canal Station 1- or more
Exclusion criteria:
Fetal head does not come out of the birth canal in one of three ways
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 111
Randomization (investigator's opinion)
Not 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 Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2020-07-15, 1399/04/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.251

Health conditions studied

1

Description of health condition studied
Three methods of delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Duration of surgery
Timepoint
During surgery
Method of measurement
The duration of surgery is taken in three groups

2

Description
The rate of bladder trauma
Timepoint
During the operation
Method of measurement
Trauma to the bladder is measured during surgery from skin incision to suturing

3

Description
The degree of trauma to the pelvic organs
Timepoint
During the operation
Method of measurement
During surgery, from the incision of the skin to the suturing of the skin, the amount of trauma to the pelvic organs is measured

4

Description
Bleeding volume during cesarean section
Timepoint
During the operation
Method of measurement
Bleeding is measured during surgery from skin incision to suturing

5

Description
Extension of uterine incision
Timepoint
During the operation
Method of measurement
During surgery, from the incision of the skin to the suturing of the skin, the extent of extension of the uterine incision is measured

6

Description
Uterine vascular involvement
Timepoint
During the operation
Method of measurement
Uterine vascular involvement is measured during surgery from skin incision to suturing

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
After surgery
Method of measurement
The length of hospital stay is taken

2

Description
Trauma to the baby's limbs
Timepoint
After surgery
Method of measurement
The extent of trauma to the baby's limbs is assessed

3

Description
Duration of hospitalization of the baby
Timepoint
After surgery
Method of measurement
The length of the baby's hospital stay is taken

Intervention groups

1

Description
In group one, the fetus is removed by pushing the head and cephalic. Neonatal trauma, the need for hospitalization at the NICU, and the length of time the mother and baby are hospitalized are compared and compared.
Category
Diagnosis

2

Description
In group two, we remove the embryos by pulling the legs and breeches. The duration of surgery from skin incision to skin suturing, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, neonatal apical Neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared.
Category
Diagnosis

3

Description
Intervention group: In the third group, we remove the fetus by removing the anterior shoulder. The amount of surgery from skin incision to suturing the skin, the amount of bleeding during cesarean section, intraoperative complications including enlarged incision, bladder trauma, uterine artery rupture, Infant apnea, neonatal trauma, the need for NICU hospitalization, and the length of time the mother and baby are hospitalized are compared and compared.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Farideh Akhlaghi
Street address
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St,
City
Mashhad
Province
Razavi Khorasan
Postal code
91447 34756
Phone
+98 51 3223 1061
Email
AkhlaghiF@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3841 2081
Email
AkhlaghiF@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Akhlaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St
City
Mashhad
Province
Razavi Khorasan
Postal code
91447 34756
Phone
+98 51 3223 1061
Email
AkhlaghiF@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Akhlaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St,
City
Mashhad
Province
Razavi Khorasan
Postal code
91447 34756
Phone
+98 51 3223 1061
Email
AkhlaghiF@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Akhlaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St
City
Mashhad
Province
Razavi Khorasan
Postal code
91447 34756
Phone
+98 51 3223 1061
Email
AkhlaghiF@mums.ac.ir

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
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