N/A
N=435
A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam
GDM
Bottom Line
View on ClinicalTrials.gov: NCT05744856 ↗Enrolled (actual)
435
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Large for Gestational Age (LGA) — 23; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-care with informal support (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Thai Binh University of Medicine and Pharmacy
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Large for Gestational Age (LGA) |
30; 19 | — |
| PRIMARY Large for Gestational Age (LGA) |
30; 19 | — |
| PRIMARY The Feasibility of the Self-care Intervention [Recruitment] |
202 | — |
| PRIMARY The Feasibility of the Self-care Intervention [Retention] |
156 | — |
| PRIMARY The Acceptability of the Self-care Intervention |
3.9 | — |
| SECONDARY Mode of Delivery |
77; 68; 138; 124; 11; 9 | — |
| SECONDARY Pre-term Birth Below Gestational Age 37+0 |
— | — |
| SECONDARY Gestational Age |
— | — |
| SECONDARY Birth Weight |
— | — |
| SECONDARY Macrosomia |
— | — |
| SECONDARY Macrosomia (Vietnam) |
— | — |
| SECONDARY Live-born |
— | — |
| SECONDARY Small for Gestational Age (SGA) |
— | — |
| SECONDARY Apgar Score |
— | — |
| SECONDARY Neonatal Hypoglycemia |
— | — |
| SECONDARY Maternal Gestational Weight Gain |
— | — |
| SECONDARY HbA1c |
— | — |
| SECONDARY Breast Feeding Practices |
— | — |
| SECONDARY Post-partum Depression |
— | — |
| SECONDARY Perceived Social Support |
— | — |
| SECONDARY Well-being |
— | — |
| SECONDARY Self-care Agency |
— | — |
| SECONDARY Self-care of GDM |
— | — |
Summary
Gestational Diabetes Mellitus (GDM) is significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their families in today's Vietnam handle the condition. Vietnamese women often depend on their extended family for daily life management and access to social and financial resources, hence, an intervention that focuses on informal support and GDM self-care may increase adherence the standard guidelines among pregnant women with GDM in Vietnam and increase neonatal and maternal health outcomes.
Eligibility Criteria
Inclusion Criteria
- Pregnancy < 28 weeks
- Singleton and multiple pregnancies
- Residing in Thai Binh province
- Speaks and reads Vietnamese
- Agree to participate voluntarily (informed consent)
Exclusion Criteria
- Pre-gestational diabetes (type I or type II)
- Severe chronic disease
Women with GDM in a prior pregnancy are eligible for inclusion into the study.
Data sourced from ClinicalTrials.gov (NCT05744856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.