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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05202002
Other study ID # CMC-20-0041-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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