Decrease Type II Diabetes in Gestational Diabetes Population

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Breastfeeding; Gestational Diabetes; Diabetes Mellitus, Type 1; Impaired Glucose Tolerance
• Interventions: Behavioral: Video clip; Behavioral: No video clip

• Registration Number: NCT05202002
• Lead Sponsor: Carmel Medical Center

Brief Summary

The goal of the study is to examine the impact of an educational video on the rate of breastfeeding in mothers who had gestational diabetes mellitus, and the rate of type-II diabetes mellitus diagnosed postpartum.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-08
• Study First Submitted QC: 2022-01-08
• Study First Posted: 2022-01-21
• Last Update Submitted: 2022-01-22
• Last Update Posted: 2022-02-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Pregnant individuals aged over 18 years old
• Diagnosed with Gestational Diabetes Mellitus (GDM) by 100gm oral glucose tolerance test (OGTT) done between week 24-28 of gestation, or by other criteria (50gm glucose challenge test (GCT) >200 mg/dl22 or having one abnormal value in OGTT )
• Having pregestational diabetes (DM-I or DM-II)
• Can read and understand Hebrew

Exclusion Criteria

• Delivery of a non-viable fetus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational video	Video clip	Participants will receive an online video clip, explaining the benefits of breastfeeding.
Control group	No video clip	Participants will not receive the video clip

Primary Outcome Measures

Name	Time	Method
Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT)	A phone call at 6 weeks postpartum.	Participants are requested to perform 75gm oral glucose tolerance test (OGTT) postpartum, as a screening test for type I diabetes mellitus. We will record the results and compare between groups

Secondary Outcome Measures

Name	Time	Method
Rate of OGTT performance	A phone call at 6 weeks postpartum.	Determination the actual performance of the test
Rate of impaired glucose tolerance (IGT)	A phone call at 6 weeks postpartum.	Similar to primary outcome
Rate of exclusive breastfeeding	A phone call at 6 weeks postpartum.	Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant

Trial Locations

Locations (1)

Carmel MC; 🇮🇱 Haifa, Israel