The effect of implementation of the centering pregnancy group prenatal educational-care model in pregnant women with diabetes: A randomized controlled trial
The effect of implementation of the centering pregnancy group prenatal educational-care model in pregnant women with diabetes
Design
A clinical trial with a control group, and parallel groups, randomized, on 100 pregnant women with diabetes, and for randomization, stratified randomized block method (gestational diabetes and type 2 diabetes) will be used with block sizes of 4 and 6 and allocation ratio of 1:1.
Settings and conduct
This study is a randomized controlled trial that will be implemented in hospitals and health centers in Tabriz. Women will be randomly assigned to intervention and control groups. The intervention group will receive the Centering Pregnancy educational-care model and the control group will receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with gestational diabetes or type 2 diabetes; between 24 and 28 weeks of gestational age
Exclusion criteria: Women with multiple pregnancies; suffering from advanced and complicated diabetes.
Intervention groups
For participants in the intervention, in addition to routine pregnancy care, there will be eight weeks of group meetings held every two weeks, lasting 2 hours. The number of participants in each group will be variable from 2 to 10 women. In each session, predetermined topics that focus on the patient's needs and are related to the content (diabetes, pregnancy, and health-related practices) will be provided.
The effect of implementation of the centering pregnancy group prenatal educational-care model in pregnant women with diabetes: A randomized controlled trial
Public title
The effect of implementation of the group educational-care model in pregnant women with diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational diabetes or type 2 diabetes
Gestational age 24 to 28 weeks
The possibility of the presence of participants (according to the place of residence) in group meetings before childbirth, for 8 weeks at specific places and times in the city of Tabriz.
Exclusion criteria:
Multiple pregnancy
Major fetal anomalies
The presence of medical diseases
The presence of psychiatric diseases
Suffering from advanced and complicated diabetes (nephropathy, retinopathy and neuropathy)
Age
From 10 years old to 54 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign the participants to the study groups, the stratified random block method (gestational diabetes and type 2 diabetes) will be used with block sizes of 4 and 6 and with an allocation ratio of 1:1. In order to Allocation Concealment, the central method will be used, for this purpose, some details of the participants will be sent to the supervisor via SMS and they will send the placement group of the individual in the study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the current study, blinding participants, clinical caregivers, outcome assessors, and intervention providers to group allocation will not be feasible due to the nature of the intervention. However, we will implement participant coding to ensure the data analyst remains blind to group assignment. Through participant coding, the data analyst will not have access to information regarding which participants belong to which group. This approach will be implemented to minimize bias during data analysis and ensure the impartiality of data interpretation.
Placebo
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
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-12-04, 1402/09/13
Ethics committee reference number
IR.TBZMED.REC.1402.652
Health conditions studied
1
Description of health condition studied
prenatal care
ICD-10 code
Z35.8
ICD-10 code description
Supervision of other high-risk pregnancies
Primary outcomes
1
Description
Mean score of self-care activities
Timepoint
Before the intervention and after completing the intervention in the 36-39 weeks of pregnancy
Method of measurement
Summary of the Diabetes Self-Care Activities (SDSCA)
2
Description
Diabetes Management Self-Efficacy
Timepoint
Before the intervention and after completing the intervention in the 36-39 weeks of pregnancy
Method of measurement
DMSES= Diabetes Management Self-Efficacy Scale
3
Description
Pregnancy Experience
Timepoint
Before the intervention and after completing the intervention in the 36-39 weeks of pregnancy
Method of measurement
Pregnancy Experience Scale (PES)
Secondary outcomes
1
Description
Frequency of preterm labor
Timepoint
Sixth week postpartum based on the medical record
Method of measurement
Maternal and neonatal outcomes checklist
2
Description
Frequency of cesarean delivery
Timepoint
Sixth week postpartum based on the medical record
Method of measurement
Maternal and neonatal outcomes checklist
3
Description
The frequency of hospitalization of newborns in the intensive care unit
Timepoint
Sixth week postpartum based on the medical record
Method of measurement
Maternal and neonatal outcomes checklist
4
Description
Breastfeeding performance score
Timepoint
Sixth week postpartum
Method of measurement
Breastfeeding performance questionnaire
5
Description
Satisfaction score of prenatal care
Timepoint
After completing the intervention in 36-39 weeks of pregnancy
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: For individuals in the intervention group, in addition to routine prenatal care, an eight-week intervention will be provided in the form of group sessions held every two weeks, lasting for 2 hours. Each group will consist of 2 to 10 women and will be facilitated and managed by a midwife (a doctoral student in midwifery). The content of each session will be based on the curriculum and content of centering pregnancy. Expert opinions (including a perinatologist, nutrition specialist, fertility and reproductive health specialist, and midwife) will be used to validate the session content. At the beginning of each session, introductions will be made, followed by discussions about the group's expectations. Measurements of weight, blood pressure, and blood glucose chart review will also be conducted, which will take approximately 30 minutes. Each session will focus on predetermined topics related to the patient's needs and content will be delivered accordingly. The remaining 60 to 90 minutes of each session will be dedicated to group discussions on diabetes, pregnancy, and behavioral health. Session 1: Diabetes education will include explanations of the risks of diabetes for both the mother and the fetus, the importance of self-monitoring, nutrition education in the form of introducing food groups and the importance of meal control, introduction to food labels, and education on pregnancy-related concerns and coping mechanisms. Session 2: Diabetes education will cover exercise and its importance, while pregnancy education will focus on pain relief during labor and partner sexual violence. Session 3: Diabetes education will include postpartum diabetes and what occurs during the postpartum period, as well as the importance of glucose tolerance testing. Pregnancy education will cover expectations during labor and delivery, contraception, and breastfeeding. Session 4: Diabetes education will focus on lifelong health monitoring and the risk of diabetes for offspring, while pregnancy education will cover infant care (sleeping, car seat safety, and nutrition).
Category
Behavior
2
Description
Control group: The control group will receive standard care according to national guidelines.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani educational and therapeutic center
Full name of responsible person
Mahsa Maghalian
Street address
Rahahan Square
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4421
Fax
+98 41 3442 4882
Email
taleghanihospital.tabriz@gmail.com
Web page address
https://taleghanihosp.tbzmed.ac.ir/
2
Recruitment center
Name of recruitment center
AlzahraTherapeutic Educational Center
Full name of responsible person
Mahsa Maghalian
Street address
Baghshmal intersection, South army street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
hrahospital@tbzmed.ac.ir
3
Recruitment center
Name of recruitment center
29 Bahman hospital
Full name of responsible person
Mahsa Maghalian
Street address
29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
444851335
Phone
+98 41 3330 7000
Email
29bahman.tamin@tbzedmed.ac.ir
4
Recruitment center
Name of recruitment center
Community health centers of Tabriz
Full name of responsible person
Mahsa Maghalian
Street address
Community health centers of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Email
iro@tbzmed.ac.ir
5
Recruitment center
Name of recruitment center
Alghadir Hospital
Full name of responsible person
Mahsa Maghalian
Street address
Jahad Square, nesferah street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۸۳۷۱۳۱۳۳
Phone
+98 41 3440 5763
Email
info@tabrizhospital.ir
6
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mahsa Maghalian
Street address
Zafaranieh street - Valiasr Hospital, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166618514
Phone
+98 41 3327 3000
Email
info@tabrizhospital.ir
7
Recruitment center
Name of recruitment center
Behbood Hospital
Full name of responsible person
Mahsa Maghalian
Street address
Artesh jonoobi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5137645864
Phone
+98 41 3553 8701
Email
behboudhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mahsa Maghalian
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
mahsamaghalian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
mirghafourvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098347501708
Email
mirghafourvand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of participants' information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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