Gestational DiabetesNCT05670769
The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care
A study testing Education in people with Gestational Diabetes and Pregnancy, High Risk, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy, High Risk
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Knowing Turkish and being literate
- Absence of fetal anomaly
- Having been diagnosed with gestational diabetes
- 24-28 and above gestational weeks
Who cannot join
- Communication difficulties
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cemile Onat Koroglu
Adana
Cemile Onat Koroglu, Msc, 0903223386484 ext. 1213, cmk_4231@outlook.com
Sule Gokyildiz Surucu, Prof.
Cukurova University
Adana
Cemile Onat Koroglu, Msc, 0903223386484 ext. 1213, cmk_4231@outlook.com
Sule Gokyildiz Surucu, Prof.
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy, High Risk
- Being tested
- Education
- Keywords
- Midwifery, home care, gestational diabetes, attitude, self care
- Medical subject headings
- Diabetes, Gestational, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | * 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. Receives: Other: Education |
| Control | No intervention | * 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention, Attitude and Behavior Scale in Gestational Diabetes
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Measured: 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
Diabetes Self-Care Activities Questionnaire
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Onat Koroglu, Cukurova University
- Investigators
- Cemile Onat Koroglu, Msc, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670769
- Sponsor's protocol ID
- 04.11.2022/37
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care
- ClinicalTrials.gov ID
- NCT05670769
- Acronym / sponsor ID
- 04.11.2022/37
- Conditions
- Gestational Diabetes, Pregnancy, High Risk
- Keywords
- Midwifery, home care, gestational diabetes, attitude, self care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Education* 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. |
| Control | No intervention | –* 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Knowing Turkish and being literate
- Absence of fetal anomaly
- Having been diagnosed with gestational diabetes
- 24-28 and above gestational weeks
Key exclusion criteria (1 listed)
- Communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThe 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.). | Other | Experimental |
Primary outcome
Intention, Attitude and Behavior Scale in Gestational Diabetes
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
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Diabetes Self-Care Activities Questionnaire
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
Change from the level of knowledge and awareness about perinatal mental health at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemile Onat Koroglu, Msc principal investigator
Cukurova University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Gestational Diabetes and Pregnancy, High Risk, run by Cukurova University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cemile Onat Koroglu, Msc (0903223386484 ext. 1213, cmk_4231@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention, Attitude and Behavior Scale in Gestational Diabetes (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.