Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05141929
Other study ID # 2908-GOA-2019/01-25
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date August 30, 2021

Study information

Verified date December 2021
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled study aimed to examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.


Description:

Objective: To examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results. Design: Randomized controlled study. Patients: Thirty one pregnant women were included in the intervention group and thirty four pregnant women in the control group. Interventions: For 8 weeks, web-based education for Gestational Diabetes Mellitus was offered to pregnant women who diagnosed with Gestational Diabetes Mellitus for the first time. The data were collected before web-based education, after web-based education and postpartum between 4-12 weeks at three different times. Control group was offered routine clinical procedure. Main Outcome Measures: health management self efficacy (primary outcomes), maternal-fetal-neonatal results (secondary outcome).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 30, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being 18 years or older - Being primigravida or multigravida - Getting a diagnosis of Gestational Diabetes Mellitus - Having a gestational week between 24-28 - Having a single fetus - Ability to use the Internet (Computer, tablet, smart phone, etc.) - Voluntary participation in the research Exclusion Criteria: - Having a diagnosis of Type 1 and Type 2 Diabetes Mellitus - Having another chronic disease - Having a visual or hearing impairment - Having a psychiatric medical diagnosis - Having a diagnosis of risky pregnancy not related to GDM

Study Design


Intervention

Behavioral:
web based education
In addition to routine care, web-based education was offered to pregnant women with Gestational Diabetes Mellitus.

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Self Rated Abilities for Health Practices levels in pregnant women with GDM Self Rated Abilities for Health Practices Scale: Self Rated Abilities for Health Practices Scale: The 5-point Likert scale was adapted for Turkish version by Aypar Akbag and Alus Tokat (Aypar Akbag and Alus Tokat, 2021). The scale consists of 4 sub-dimensions: "Exercise"," Responsible Health Practices", "Psychological Well Being" and "Nutrition". (from 0 (not at all) to 4 (completely). The scale total-score ranged between 0 and 112, while subscale total-scores ranging from 0 to 28 points. The higher scores from the scale indicate higher self-efficacy levels for the health applications. Change in Self Rated Abilities for Health Practices levels up to postpartum 12th week
Secondary Rate of maternal-fetal-neonatal complications in pregnant women with GDM The chart was used to evaluate the maternal (ketoacidosis, preeclampsia, polyhydramnios, preterm labor, vaginal or urinary infection), fetal (macrosomia, Intrauterine Growth Retardation) and neonatal (neonatal hypoglycemia, polycythemia and neonatal hyperbilirubinemia, duration of treatment for hyperbilirubinemia, Respiratory Distress Syndrome (RDS), hypothermia, dehydration) complications of Gestational Diabetes Mellitus. Complications during pregnancy and postpartum period were followed up. Complication follow-up was done by contacting the intervention group via the website. In the control group, complication follow-up was obtained by phone calls. Change in rate of maternal, fetal and neonatal complications up to postpartum 12th week
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Completed NCT06338254 - Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women N/A
Recruiting NCT04825093 - Vitamin D Supplementarion in Pregnant Women at Risk and COVID-19 N/A
Completed NCT04739462 - SMS Maama Project COVID-19 N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06430853 - Psychobiological Interventions in Pregnancy N/A
Not yet recruiting NCT06357962 - Semi-permanent Acupuncture Effect on Cervical Ripening N/A
Not yet recruiting NCT03661749 - Urinary Protein to Creatinine Ratio in Term Pregnant Women N/A
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Completed NCT02191774 - Medical Abortion up to 10 Weeks Gestation at Home
Completed NCT01322529 - Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be N/A
Completed NCT00746551 - Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment Phase 4
Completed NCT00678080 - Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes N/A
Completed NCT00634530 - Impact of a Nutritional Intervention Program for Weight Control During Pregnancy N/A
Completed NCT00197561 - Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection Phase 3
Completed NCT05527327 - Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study N/A
Recruiting NCT05551078 - Thrombophilia Screening After Severe IUGR
Recruiting NCT03100084 - PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome