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Decrease Type II Diabetes in Gestational Diabetes Population

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05202002
Enrollment
200
Registered
2022-01-21
Start date
2021-03-01
Completion date
2023-05-30
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALVideo 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.

BEHAVIORALNo video clip

Participants in this group will receive a unique identifier that belongs to the control group, thus no video clip will be displayed.

Sponsors

Carmel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Rate of exclusive breastfeedingA 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
Rate of OGTT performanceA 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

Countries

Israel

Contacts

Primary ContactNadav Cohen, MD
nadavmed88@gmail.com+97248250336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026