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The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care

Primary Purpose

Gestational Diabetes, Pregnancy, High Risk

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring Midwifery, home care, gestational diabetes, attitude, self care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Knowing Turkish and being literate Absence of fetal anomaly Having been diagnosed with gestational diabetes 24-28 and above gestational weeks Exclusion Criteria: Communication difficulties

Sites / Locations

  • Cemile Onat Koroglu
  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

All forms will be filled in by the pregnant women at the beginning of the study. The first interview will be face-to-face at the hospital. A calendar will be created about home visits and timings for home midwifery care and counseling by meeting the pregnant woman at the hospital and obtaining their contact information. Weekly home visits will be made to the pregnant women in the first month and training will be provided with the training booklet developed in line with the home midwifery care model based on the continuous midwifery care model during the home visits. Afterwards, two more home visits will be made to the pregnant women on a monthly basis and a total of 6 home visits will be made. Pregnant women will be in constant communication via mobile phone. After the sixth home visit, the Intention, Attitude and Behavior Scale in Gestational Diabetes and the Diabetes Self-Care Activities Questionnaire will be filled.

All forms will be filled in by the pregnant women at the beginning of the study. Pregnant women in the control group will not be subjected to any application other than the routine pregnancy follow-up and examinations recommended in the hospital. Forms will be filled in parallel with the intervention group

Outcomes

Primary Outcome Measures

Intention, Attitude and Behavior Scale in Gestational Diabetes
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Diabetes Self-Care Activities Questionnaire
Change from the level of knowledge and awareness about perinatal mental health at 3 months

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
December 20, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05670769
Brief Title
The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care
Official Title
The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Since gestational diabetes carries the risk of serious complications for the mother and fetus, it is very important to follow up the pregnancy carefully and consciously. Home follow-up and prenatal care of these pregnant women, whose outpatient follow-up is continued without hospitalization, gains great importance. This study was planned as a randomized controlled experimental study to determine the effects of home midwifery care based on the continuous midwifery care model for pregnant women diagnosed with gestational diabetes, on the attitudes and self-care of pregnant women. The universe of this research, which will be carried out in a randomized controlled experimental type, will consist of pregnant women who applied to Çukurova University Balcalı Hospital Health Application and Research Center Gynecology and Obstetrics Department Pregnancy Polyclinic. The sample number was calculated by the Sample Size Calculator analysis and it was planned to include 24 participants in the experimental group and 24 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. The research will be conducted in the form of pre-test and post-test. The pre-test will be applied at the first encounter before the midwifery training, and the post-test will be applied after the 6th training. Data; It will be collected with the Pregnant Introductory Form, Intention, Attitude and Behavior Scale in Gestational Diabetes and Diabetes Self-Care Activities Questionnaire. Statistical Program for Social Science 22 will be used in data analysis. The data will be analyzed with appropriate analysis methods after testing for normality. The main subject of this research is to improve maternal and fetal health by providing continuous midwifery care at home for pregnant women who are diagnosed with gestational diabetes and are in the risky pregnancies group. With individual and continuous midwifery care provided at home, the self-care of women is strengthened and the intention, behavior and attitude towards both pregnancy and the health problem she has experienced are positively affected, contributing to the reduction of possible complications and providing a cost-effective service reveals the importance and necessity of the research.
Detailed Description
This study was planned as a randomized controlled study to determine the effect of home midwifery care given to pregnant women diagnosed with gestational diabetes on the attitudes and self-care of pregnant women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Pregnancy, High Risk
Keywords
Midwifery, home care, gestational diabetes, attitude, self care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
All forms will be filled in by the pregnant women at the beginning of the study. The first interview will be face-to-face at the hospital. A calendar will be created about home visits and timings for home midwifery care and counseling by meeting the pregnant woman at the hospital and obtaining their contact information. Weekly home visits will be made to the pregnant women in the first month and training will be provided with the training booklet developed in line with the home midwifery care model based on the continuous midwifery care model during the home visits. Afterwards, two more home visits will be made to the pregnant women on a monthly basis and a total of 6 home visits will be made. Pregnant women will be in constant communication via mobile phone. After the sixth home visit, the Intention, Attitude and Behavior Scale in Gestational Diabetes and the Diabetes Self-Care Activities Questionnaire will be filled.
Arm Title
Control
Arm Type
No Intervention
Arm Description
All forms will be filled in by the pregnant women at the beginning of the study. Pregnant women in the control group will not be subjected to any application other than the routine pregnancy follow-up and examinations recommended in the hospital. Forms will be filled in parallel with the intervention group
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
The training module, which will be developed in line with the continuous midwifery care model, will include home care and counseling of pregnant women with gestational diabetes (glucose monitoring and control, diet, exercise, evaluation of fetal health, etc.).
Primary Outcome Measure Information:
Title
Intention, Attitude and Behavior Scale in Gestational Diabetes
Description
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Time Frame
pre-intervention, immediately after the intervention, after 1 month. An increase in the score is interpreted as an increase in the level of knowledge and attitude about perinatal mental
Title
Diabetes Self-Care Activities Questionnaire
Description
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Time Frame
pre-intervention, immediately after the intervention, after 1 month. An increase in the score is interpreted as an increase in the level of knowledge and self care about perinatal mental

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnancy
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Knowing Turkish and being literate Absence of fetal anomaly Having been diagnosed with gestational diabetes 24-28 and above gestational weeks Exclusion Criteria: Communication difficulties
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cemile Onat Koroglu, Msc
Phone
0903223386484
Ext
1213
Email
cmk_4231@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sule Gokyildiz Surucu, Prof
Phone
0903223386484
Ext
1213
Email
gokyildizsule@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemile Onat Koroglu, Msc
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cemile Onat Koroglu
City
Adana
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile Onat Koroglu, Msc
Phone
0903223386484
Ext
1213
Email
cmk_4231@outlook.com
First Name & Middle Initial & Last Name & Degree
Sule Gokyildiz Surucu, Prof.
Facility Name
Cukurova University
City
Adana
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile Onat Koroglu, Msc
Phone
0903223386484
Ext
1213
Email
cmk_4231@outlook.com
First Name & Middle Initial & Last Name & Degree
Sule Gokyildiz Surucu, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care

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