Decrease Type II Diabetes in Gestational Diabetes Population

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Decreasing the Incidence of Post-partum Type II Diabetes Mellitus in Gestational Diabetes Population- Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202002
• Other study ID #: CMC-20-0041-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2022
• Source: Carmel Medical Center
• Contact: Nadav Cohen, MD
• Phone: +97248250336
• Email: nadavmed88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Behavioral:
• Video clip
After obtaining written informed consent, participants received a sealed envelope containing a preprinted paper referral to an online website, with a unique identifier. After entering the online website, participants will be asked to enter the unique identifier they have received into a text box. Only those whose identifiers were predetermined to be associated with the intervention group will receive the intervention. The intervention is twenty minutes long educational video clip, in which a brief discussion was presented, by an obstetrician, pediatrician, dietitian, and a breastfeeding consultant, each presenting the benefits of breastfeeding for mother and newborn.
• No video clip
Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.

Locations

Country	Name	City	State
Israel	Carmel MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Gunderson EP, Hedderson MM, Chiang V, Crites Y, Walton D, Azevedo RA, Fox G, Elmasian C, Young S, Salvador N, Lum M, Quesenberry CP, Lo JC, Sternfeld B, Ferrara A, Selby JV. Lactation intensity and postpartum maternal glucose tolerance and insulin resista — View Citation

McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2:CD001141. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of type II Diabetes Mellitus (DM) diagnosis, as diagnosed by the 75gm oral glucose tolerance test (OGTT)	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	A phone call at 6 weeks postpartum.
Secondary	Rate of OGTT performance	Determination the actual performance of the test	A phone call at 6 weeks postpartum.
Secondary	Rate of impaired glucose tolerance (IGT)	Similar to primary outcome	A phone call at 6 weeks postpartum.
Secondary	Rate of exclusive breastfeeding	Participants will be asked by a phone cell, about feeding habits, including exclusive, partial and no breastfeeding of the infant	A phone call at 6 weeks postpartum.