Determining and comparing mothers' satisfaction and childbirth outcomes in the intervention and control groups after the intervention
Design
Clinical trial with control group, with parallel groups, randomized, on 50 pregnant mothers, randomization will be done with the help of Excel software.
Settings and conduct
Eligible pregnant women will be placed in one of two test and control groups using computer randomization with Excel software. In addition to routine pregnancy care, the test group will participate in birth preparation classes and acupressure sessions and prepare for a natural delivery. The control group will only undergo routine pregnancy care and will eventually undergo repeated cesarean section.
Participants/Inclusion and exclusion criteria
Women with a history of cesarean section in the age group under 40 years old with a history of transverse cesarean section
Intervention groups
Natural childbirth in the intervention group and repeat cesarean section in the control group
Main outcome variables
Birth outcomes; mothers' satisfaction; the number of natural births after caesarean section, the relative frequency of mothers referring for natural births after caesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091219002889N14
Registration date:2023-04-02, 1402/01/13
Registration timing:prospective
Last update:2023-04-02, 1402/01/13
Update count:0
Registration date
2023-04-02, 1402/01/13
Registrant information
Name
Mahboubeh Valiani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4640
Email address
valiani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of intervention program for normal vaginal Birth after cesarean section
Public title
Vaginal Birth after cesarean section in women with a history of cesarean section
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Resident of Isfahan city
Score 5 and above according to Flam et al 's scoring table
No history of known mental disorders based on the contents of the file
Age less than 40 years
Normal vital signs of the mother
No history of intrauterine death (IUFD)
Absence of the cause of previous cesarean including: long labor, presentation of breech, fetal distress
Single embryo
Lack of track record
Absence of pelvic stenosis
History of transverse cesarean section
Normal body mass index (19.8-24)
Current non-pregnancy with assisted reproduction methods
The interval between the current pregnancy and the previous cesarean delivery is at least 18 months
Absence of any disease or complication that hinders natural delivery according to gynecologist
Willingness to participate in the study
Exclusion criteria:
Twin pregnancy
Previous cesarean vertical incision
Unwillingness to participate in the study
Body mass index above 25
Non-Iranian nationality
Pregnancy with the help of assisted reproduction methods
Suffering from a disease or complication that, according to experts, prohibits natural childbirth
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
By referring to the research environment, the researcher will take a detailed medical and obstetric history from the mothers who have a history of one cesarean section, and after reviewing the entry criteria and explaining the objectives and methods of the study, he will suggest participation in the research to the participants. and will obtain written informed consent from them to participate in the study. The randomization method will be simple and individual. Eligible pregnant women will be placed in one of two test and control groups using computer randomization with Excel software.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.175
Health conditions studied
1
Description of health condition studied
Vaginal Birth after Cesarian
ICD-10 code
O75.7
ICD-10 code description
Vaginal delivery following previous caesarean section
Primary outcomes
1
Description
Mother's satisfaction
Timepoint
In 24 hours after delivery
Method of measurement
Questionnaire of satisfaction of natural childbirth and cesarean delivery by Pakari et al
2
Description
Obstetric outcomes
Timepoint
The first 24 hours after delivery
Method of measurement
Checklist made by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women with a history of previous caesarean section in their current pregnancy will undergo natural delivery intervention
Category
N/A
2
Description
Control group: Women with a history of caesarean section in the current pregnancy will undergo a repeat cesarean section
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
All hospitals under the supervision of Isfahan University of Medical Sciences
Full name of responsible person
mahboobeh valiani
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 319 7959
Email
valiani@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. GholamReza Asgari
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4 - Vice-Chancellor for Research and Technology of the University
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Nursing and Midwifery College
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7537
Email
valiani@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Nursing and Midwifery College
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7537
Email
Valiani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahbooneh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Nursing and Midwifery College
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7537
Email
Valiani@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main implications of the study will be shared
When the data will become available and for how long
Data access starts 6 months after results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For the knowledge and use of other researchers in their next similar studies
From where data/document is obtainable
Email: valiani@nm.mui.ac.ir
What processes are involved for a request to access data/document
The researcher must send a request to send information with a valid organizational email or university email