Determining the impact of implementing continuous team care of pregnant women on safe motherhood indicators
Design
The clinical trial has a control group, with parallel groups, randomized, and the assignment method is randomized permutation blocks with a block size of 4 (using the table related to random permutations) and the ratio of assignment to intervention and control groups is 1. It will be: 1. It will be done on 200 low-risk pregnant women. 100 people are in the control group and 100 people are in the intervention group.
Settings and conduct
The study is carried out in the health and treatment centers of Kashan city. In the intervention group, pregnant women receive obstetric care as a team and continuously by a team of 5 midwives with the support of a gynecologist, but in the control group, they receive care routinely and without continuous care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Pregnant Women aged 18 to 35 years
2. Iranian 3. Singleton pregnancy 4. First pregnancy visit (less than 12 weeks of pregnancy) 5. Low-risk pregnancy
Exclusion criteria:1. Women with a history of infertility
2. A history of anxiety or hospitalization in psychiatric wards
Intervention groups
In the intervention group, care is continuously provided to pregnant women by a 5-person midwifery team throughout pregnancy, delivery and after delivery, the midwife of the health department is the responsible midwife for every pregnant woman. If pregnant women need specialized care, the midwife will refer them to a specialist and get feedback.
Control group: the provision of care in this group will be non-continuous and non-continuous according to the current state of government centers.
Main outcome variables
Safe motherhood indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037279N4
Registration date:2023-04-17, 1402/01/28
Registration timing:prospective
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
farzaneh nasiri
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 453 6915
Email address
farzanehnasiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementation continuity of team midwifery care model on safe motherhood indicators
Public title
Effect of continuity of team care model on safe motherhood indicators
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant Women aged 18 to 35 years
Iranian
Singleton pregnancy
First pregnancy visit (less than 12 weeks of pregnancy)
Low-risk pregnancy
Exclusion criteria:
Women with a history of infertility
A history of anxiety or hospitalization in psychiatric wards
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The study subjects will be assigned to each of the control and intervention groups by random block method using blocks 4 and 6 and will be divided into two groups with a ratio of 1:1. Thus, the number of 10 blocks of 6 and 16 blocks of 4 will be randomly extracted using WIN PEPI software. In each of the blocks of 6, 3 people will be related to the control group and 3 people will be related to the intervention group, also in each of the blocks of 4 people, 2 people will be related to the control group and 2 people will be related to the intervention group. The placement order of each person is random. In order to hide the allocation, the type of intervention will be written on paper and placed inside opaque envelopes numbered consecutively, in this way, the researcher and the participant will not know the type of intervention until the intervention begins. Due to the nature of this study, it will not be possible to blind the researcher and the participant.
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 Ahvaz University of Medical Sciences
Street address
No. 45, 15 Muftah St
City
Qom
Province
Ghoum
Postal code
1985717443
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.AJUMS.REC.1402.010
Health conditions studied
1
Description of health condition studied
Low-risk pregnant Women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of satisfaction with childbirth in the McKay questionnaire
Timepoint
After delivery
Method of measurement
Mackey childbirth satisfaction rating scale
2
Description
Score of depression, anxiety and stress in the questionnaire
Timepoint
Third trimester of pregnancy and 6 weeks after delivery
Method of measurement
Depression anxiety and Stress Scale
3
Description
Antenatal care quality score in pregnancy care quality questionnaire
Timepoint
After delivery
Method of measurement
The Quality Prenatal Care Questionnaire
4
Description
Consequences of pregnancy
Timepoint
End of intervention
Method of measurement
View the hospital record
5
Description
Neonatal consequences
Timepoint
End of intervention
Method of measurement
View the hospital record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hiring a responsible midwife for every pregnant woman. This midwife is a member of the management team and provides direct care during the prenatal, delivery, and postpartum stages. If pregnant women need special care, the midwife will refer them to the specialist and will take feedback. The responsible midwife will continuously be available for pregnant women in different settings of homes, health centers, and hospitals.
Category
Other
2
Description
Control group: They will receive routine care. In a routine way, pregnant women refer to the health center. There is no responsible midwife or continuous communication with the caregiver. The majority of women are under the supervision of specialists, regardless of whether they are high-risk or low-risk. Caregivers are frequently changed during pregnancy, delivery and after delivery, and care is received by unfamiliar caregivers
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
health centers affiliated to Kashan university
Full name of responsible person
Farzane Nhnasiri
Street address
No. 45, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Qom
Province
Ghoum
Postal code
1523647859
Phone
+98 25 3423 1395
Email
nasiri.f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakir Kish
Street address
Ahawaz Academic City - Vice President of Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz - ground floor
City
Ahvaz
Province
Ghoum
Postal code
15791 61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
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
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
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Nasiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 45, 15 Muftah St
City
QOM
Province
Ghoum
Postal code
1985717443
Phone
+98 919 453 6915
Fax
Email
farzanehnasiri@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Nasiri
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 45, 15 Muftah St
City
QOM
Province
Ghoum
Postal code
0375314855
Phone
+98 25 3423 1395
Email
farzanehnasiri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Nasiri
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 45, 15 Mofatteh St
City
QOM
Province
Ghoum
Postal code
0123456789
Phone
+98 25 3423 1395
Email
farzanehnasiri100@gmail.com
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
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
Title and more details about the data/document
Demographic information and information obtained from the used questionnaire can be shared
When the data will become available and for how long