Web-based program to improve pregnant mothers' understanding of and intent to get influenza and Tdap vaccines.
Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs
This trial will test whether a short web-based education program helps pregnant women understand and feel more likely to get influenza and Tdap vaccines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 351 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universiti Putra Malaysia Academic / other |
| Locations | 4 sites (Bandar Baru Bangi, Selangor and 3 other locations) |
| Trial ID | NCT06815250 on ClinicalTrials.gov |
What this trial studies
Pregnant women up to 32 weeks' gestation are enrolled at three public health clinics in Selangor, Malaysia and randomized to receive the InTroDuce web-based educational module or routine antenatal care. The module contains videos and plain-language information on vaccine importance, safety, effectiveness, and common concerns and can be completed online during visits or at home. Investigators measure changes in vaccine knowledge, attitudes, perceived barriers, and intention to vaccinate at one month and again near term, while collecting sociodemographic and clinical data. Outcomes in the intervention and control groups are compared to see if the web-based program increases knowledge and future vaccination intention relative to standard care.
Who should consider this trial
Good fit: Pregnant women aged 18 or older, at or before 32 weeks' gestation, able to consent, and receiving care at the participating clinics are ideal candidates.
Not a fit: Women with a history of severe anaphylaxis to influenza or Tdap vaccines, non-Malaysian residents, or those already vaccinated or firmly opposed to vaccination may not receive benefit from the module.
Why it matters
Potential benefit: If successful, the program could increase pregnant women's understanding of and willingness to receive influenza and Tdap vaccines, helping protect mothers and their newborns from these infections.
How similar studies have performed: Prior digital and video-based educational interventions have shown modest improvements in maternal vaccine knowledge and intent, though effects on actual vaccine uptake have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women aged 18 years and older * Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs. * Able to understand and consent to participation in the study. Exclusion Criteria: * Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination. * Non-Malaysian
Where this trial is running
Bandar Baru Bangi, Selangor and 3 other locations
- Klinik Kesihatan Bangi — Bandar Baru Bangi, Selangor, Malaysia (Recruiting)
- Klinik Kesihatan Batu 9 — Cheras, Selangor, Malaysia (Recruiting)
- Klinik Kesihatan Balakong — Cheras, Selangor, Malaysia (Recruiting)
- Klinik Kesihatan Kajang — Kajang, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Hung Chiun Lau, Dr Fam Med — Universiti Putra Malaysia
- Study coordinator: Hung Chiun Lau, Dr Fam Med
- Email: hungchiun@upm.edu.my
- Phone: +60163502549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.