The effectiveness of midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: A mixed- method Embedded Experimental study
Determining the effectiveness of using the continuous care program of midwifery students on the clinical competence of midwifery students and childbirth outcomes and explaining the perception of students and mothers about the use of this care program.
Design
The study is a mixed- method Embedded Experimental study (primary clinical trial study and qualitative study). The clinical trial has a control group, with a parallel group, randomized, on 62 pregnant women and 29 midwifery students. A block of 4 was used for randomization.
Settings and conduct
Health centers and affiliated hospitals of Ahvaz University of Medical Sciences, including Sina and Razi hospitals and affiliated health centers
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Students:
1. Seventh and eighth semester undergraduate students of the state university
2. Willingness to participate in the study
Service recipients (pregnant mothers):
1. Pregnant women aged 18 to 40 years
2. Iranian
3. Singleton pregnancy
4. First pregnancy visit (less than 20 weeks of pregnancy)
5. Low-risk pregnancy
Exclusion criteria:
1. Having a disease that requires pregnancy care by a specialist.
2. Mental illnesses, including depression
3. Previous caesarean section
4. Use of alcohol and tobacco
Intervention groups
Intervention group:
Students who provide continue of care from the beginning of pregnancy to 6 weeks postpartum.
Pregnant women receiving continue of care by students.
Control groups:
Students who provide care to women during labor and delivery up to 6 weeks after delivery.
Women receiving routine care.
Main outcome variables
1. Clinical competence
2. Type of delivery
3. Length of labor stages
4. The amount of induction
5. Postpartum bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221227056938N1
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Fatemeh Razavinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 210 3403
Email address
fatemehrazavinia15@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: A mixed- method Embedded Experimental study
Public title
The effectiveness of midwifery continuity of care program on clinical competence of midwifery students
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Seventh and eighth semester undergraduate students of the state university
Willingness to participate in the study
Pregnant women aged 18 to 40 years
Iranian
Singleton pregnancy
First pregnancy visit (less than 20 weeks of pregnancy)
Low risk pregnancy
Exclusion criteria:
Having a disease that requires pregnancy care by a specialist.
Mental illnesses including depression
Previous caesarean section
Use of alcohol and tobacco
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of mothers in this study is accessible and easy. Students are allocated in blocks of four. Five blocks of four and 3 blocks of 3 will be formed. From each block of four, two people will be in the intervention group and two people will be in the control group, and from each block of three, two people will be in the intervention group and one person will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and students as caregivers do not know how to study and in which group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
37333-61349
Approval date
2023-01-06, 1401/10/16
Ethics committee reference number
IR.AJUMS.REC.1401.460
Health conditions studied
1
Description of health condition studied
Examining the clinical competence of students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical competence
Timepoint
after the study
Method of measurement
Questionnaire made by the researcher
2
Description
Type of delivery
Timepoint
During the study
Method of measurement
Checklist
3
Description
The length of labor stages
Timepoint
During the study
Method of measurement
Checklist
4
Description
The amount of induction and induction
Timepoint
During the study
Method of measurement
Checklist
5
Description
Postpartum bleeding
Timepoint
During the study
Method of measurement
Checklist
Secondary outcomes
1
Description
Apgar first and fifth minutes
Timepoint
During the study
Method of measurement
check list
2
Description
Hospitalization in the neonatal intensive care unit
Timepoint
During the study
Method of measurement
check list
3
Description
Start early breastfeeding
Timepoint
During the study
Method of measurement
check list
4
Description
Exclusive breastfeeding
Timepoint
During the study
Method of measurement
check list
Intervention groups
1
Description
Intervention group: provision of continuous of care by students to pregnant women.
Category
N/A
2
Description
Intervention group: Students provide pregnancy continue of care for pregnant women from the beginning of pregnancy to 6 weeks after delivery.
Category
N/A
3
Description
Control group: women who receive routine care.
Category
N/A
4
Description
Control group: Students who provide routine care during labor and delivery and continue care until 6 weeks after delivery.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center and Ahvaz Sina and Razi Hospital
Full name of responsible person
Parvin Abedi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 911 210 3403
Email
fatemehrazavinia15@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 911 210 3403
Email
fatemehrazavinia15@gmail.com
Grant name
Ahvaz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
70
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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 313 2793
Email
parvinabedi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 916 313 2793
Email
parvinabedi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Razavinia
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 911 210 3403
Email
fatemehrazavinia15@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The implications of the review can be shared anonymously.
When the data will become available and for how long
After completing the study (starting access 6 months after publication)
To whom data/document is available
Researchers working in academic and scientific institutions and policy makers.
Under which criteria data/document could be used
If you have an official letter from the scientific center
From where data/document is obtainable
To printed magazines and indexed sites.
Request to the project manager's email
What processes are involved for a request to access data/document
Six months after completing the study of the application, the data will be sent to the project manager, if the conditions are met, up to two months.