NCT05670769

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

December 20, 2022

Last Update Submit

December 20, 2022

Conditions

Gestational DiabetesPregnancy, High Risk

Keywords

Midwiferyhome caregestational diabetesattitude, self care

Outcome Measures

Primary Outcomes (2)

  • Intention, Attitude and Behavior Scale in Gestational Diabetes

    Change from the level of knowledge and awareness about perinatal mental health at 3 months

    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

    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

Study Arms (2)

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.

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

Interventions

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.).

Experimental

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Knowing Turkish and being literate
  • Absence of fetal anomaly
  • Having been diagnosed with gestational diabetes
  • and above gestational weeks

You may not qualify if:

  • Communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cemile Onat Koroglu

Adana, Turkey (Türkiye)

Location

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, GestationalBehavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Cemile Onat Koroglu, Msc

    Cukurova University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cemile Onat Koroglu, Msc

CONTACT

0903223386484cmk_4231@outlook.com

Sule Gokyildiz Surucu, Prof

CONTACT

0903223386484gokyildizsule@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 4, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

January 4, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)