Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy. Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes. A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
The mobile Health application will send women reminders to perform glucose tests and test results will be sent to the clinic personnel for evaluation. The clinic personnel will receive an alert if a woman does not send glucose charts or when there is an abnormality in the test results. In addition, women will be able to communicate with the clinic's personnel via chat, messages, phone calls, and video.
Regular follow-up according to the local clinic protocol
Baruch Padeh Medical center, Poriya
Tiberias, North, Israel
RECRUITINGEmek medical center
Afula, Israel
RECRUITINGRambam medical center
Haifa, Israel
RECRUITINGWolfson medical center
Holon, Israel
NOT_YET_RECRUITINGGalilee medical center
Nahariya, Israel
NOT_YET_RECRUITINGPatient compliance
Defined as the actual blood glucose measurements/instructed measurements ×100
Time frame: During the follow up in the clinic (around 4 months)
Mean blood glucose of the daily glucose charts
Time frame: During the follow up in the clinic (around 4 months)
Percentage of off-target glucose measurements
Time frame: During the follow up in the clinic (around 4 months)
Need for pharmacotherapy for glycemic control
Time frame: During the follow up in the clinic (around 4 months)
polyhydramnios
At least once
Time frame: During the follow up in the clinic (around 4 months)
Preeclampsia/gestational hypertension
Time frame: During the follow up in the clinic (around 4 months)
Induction of labor
Time frame: At birth
Instrumental or cesarean delivery
Time frame: At birth
shoulder dystocia
Time frame: At birth
Third- or fourth-degree perineal tears
Time frame: At birth
Neonatal birth weight
Time frame: At birth
Neonatal intensive care unit admission
Time frame: A week after delivery
Hypoglycemia of the newborn
Time frame: During hospitalization after delivery (around one week)
Respiratory morbidity of the newborn
Time frame: During hospitalization after delivery (around one week)
Number of neonates who needed phototherapy
Time frame: During hospitalization after delivery (around the first week)
Neonatal death
Time frame: During hospitalization after delivery (around the first week)
Neonatal hypocalcemia
Time frame: During hospitalization after delivery (around the first week)
Neonatal hypomagnesemia
Time frame: During hospitalization after delivery (around the first week)
Apgar score
Time frame: One and Five minutes after birth
Patients' satisfaction from the monitoring protocol
According to numeric rating scale (1-least satisfied, 10-most satisfied)
Time frame: Will be evaluated up to 2 months after birth
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