Enhancing Maternal Vaccine Knowledge and Uptake: The InTroDuce-Programme Trial

NCT06815250 | Recruiting

• 1 other identifier: InTroDuce-Programme
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are: Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers? Researchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will: Receive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns. Be followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated

Conditions

Vaccination Uptake; Knowledge; Tetanus, Diphtheria and Acellular Pertussis Vaccination; Influenza; Web Based Intervention; Vaccine Knowledge

Keywords

Influenza vaccination; Tdap vaccination; Educational module; Pregnant mothers; Vaccine knowledge; Vaccine uptake

Outcome Measures

Primary Outcomes (2)

• Knowledge of Influenza and Tdap Vaccination

  knowledge score about the importance, safety, and benefits of vaccination (vaccine literacy) will be assessed through pre- and post-intervention questionnaire

  1 month post-intervention

• Vaccination Future Uptake

  Intention of future vaccine uptake of the influenza and Tdap vaccines will be assessed using questionnaire

  1 month post-intervention

Secondary Outcomes (1)

• Barriers to vaccination uptake

  1 month post-intervention

Study Arms (2)

Control

NO INTERVENTION

Standard antenatal care

Intervention

EXPERIMENTAL

Influenza and Tdap Vaccination Web-based Educational and Learning Module (InTroDuce-Programme)

Interventions

Influenza and Tdap Vaccination Educational and Learning Module BEHAVIORAL

Influenza and Tdap learning and educational module delivered via website. The module will cover importance of vaccination for both pregnant women and infant, safety and efficacy of the influenza and TdaP vaccines, timing of vaccination, and addressing common concerns and misconceptions.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.
• Non-Malaysian

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (4)

Klinik Kesihatan Bangi

Bandar Baru Bangi, Selangor, 43650, Malaysia

RECRUITING

Klinik Kesihatan Batu 9

Cheras, Selangor, 43200, Malaysia

RECRUITING

Klinik Kesihatan Balakong

Cheras, Selangor, 43300, Malaysia

RECRUITING

Klinik Kesihatan Kajang

Kajang, Selangor, 43000, Malaysia

RECRUITING

Related Publications (13)

• O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27.

  PMID: 31471001 BACKGROUND

• Deverall EJ, Gilmore B, Illing S, Peiris-John R. Pertussis vaccination uptake in pregnancy: lessons to be learned from an integrated healthcare approach. N Z Med J. 2018 Apr 13;131(1473):42-47.

  PMID: 29649195 BACKGROUND

• Dawood FS, Kittikraisak W, Patel A, Rentz Hunt D, Suntarattiwong P, Wesley MG, Thompson MG, Soto G, Mundhada S, Arriola CS, Azziz-Baumgartner E, Brummer T, Cabrera S, Chang HH, Deshmukh M, Ellison D, Florian R, Gonzales O, Kurhe K, Kaoiean S, Rawangban B, Lindstrom S, Llajaruna E, Mott JA, Saha S, Prakash A, Mohanty S, Sinthuwattanawibool C, Tinoco Y. Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study. Lancet Infect Dis. 2021 Jan;21(1):97-106. doi: 10.1016/S1473-3099(20)30592-2. Epub 2020 Oct 29. Erratum In: Lancet Infect Dis. 2021 Jan;21(1):e1. doi: 10.1016/S1473-3099(20)30864-1.

  PMID: 33129424 BACKGROUND

• Hong EY, Kulkarni K, Gosavi A, Wong HC, Singh K, Kale AS. Assessment of knowledge and attitude towards influenza and pertussis vaccination in pregnancy and factors affecting vaccine uptake rates: a cross-sectional survey. Singapore Med J. 2023 Aug;64(8):513-516. doi: 10.11622/smedj.2021097. No abstract available.

  PMID: 34544209 BACKGROUND

• Razai MS, Mansour R, Goldsmith L, Freeman S, Mason-Apps C, Ravindran P, Kooner P, Berendes S, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Interventions to increase vaccination against COVID-19, influenza and pertussis during pregnancy: a systematic review and meta-analysis. J Travel Med. 2023 Dec 28;30(8):taad138. doi: 10.1093/jtm/taad138.

  PMID: 37934788 BACKGROUND

• Kilich E, Dada S, Francis MR, Tazare J, Chico RM, Paterson P, Larson HJ. Factors that influence vaccination decision-making among pregnant women: A systematic review and meta-analysis. PLoS One. 2020 Jul 9;15(7):e0234827. doi: 10.1371/journal.pone.0234827. eCollection 2020.

  PMID: 32645112 BACKGROUND

• Racicot K, Mor G. Risks associated with viral infections during pregnancy. J Clin Invest. 2017 May 1;127(5):1591-1599. doi: 10.1172/JCI87490. Epub 2017 May 1.

  PMID: 28459427 BACKGROUND

• Arora M, Lakshmi R. Vaccines - safety in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021 Oct;76:23-40. doi: 10.1016/j.bpobgyn.2021.02.002. Epub 2021 Feb 19.

  PMID: 33773923 BACKGROUND

• Merdrignac L, Acosta L, Habington A, Garcia Cenoz M, Pandolfi E, Fabianova K, Jordan I, O'Sullivan N, Navasues A, Tozzi AE, Zavadilova J, Jane M, Cotter S, Pitillas NI, Rizzo C, Krizova P, Hanslik T, Munoz Almagro C, Pastore L, Bacci S, Moren A, Valenciano M; PERTINENT Group. Effectiveness of pertussis vaccination in pregnancy to prevent hospitalisation in infants aged <2 months and effectiveness of both primary vaccination and mother's vaccination in pregnancy in infants aged 2-11 months. Vaccine. 2022 Oct 19;40(44):6374-6382. doi: 10.1016/j.vaccine.2022.09.054. Epub 2022 Sep 29.

  PMID: 36182617 BACKGROUND

• Razai MS, Mansour R, Ravindran P, Freeman S, Mason-Apps C, Morris J, Majeed A, Ussher M, Hargreaves S, Oakeshott P. Facilitators and barriers to vaccination uptake in pregnancy: A qualitative systematic review. PLoS One. 2024 Apr 19;19(4):e0298407. doi: 10.1371/journal.pone.0298407. eCollection 2024.

  PMID: 38640190 BACKGROUND

• Razai MS, Chaudhry UAR, Doerholt K, Bauld L, Majeed A. Covid-19 vaccination hesitancy. BMJ. 2021 May 20;373:n1138. doi: 10.1136/bmj.n1138. No abstract available.

  PMID: 34016653 BACKGROUND

• Parsons J, Griffiths SE, Thomas N, Atherton H. How effective are digital interventions in increasing flu vaccination among pregnant women? A systematic review and meta-analysis. J Public Health (Oxf). 2022 Dec 1;44(4):863-876. doi: 10.1093/pubmed/fdab220.

  PMID: 34164686 BACKGROUND

• Lau HC, Sekawi Z, Ching SM, Abu Bakar N, Dapari R, Mohamed Alias SR, Talib NH, Dzulkifli IH, Md Alwi N, Abdul Hamid H, Mat Din H. Effectiveness of the influenza and Tdap vaccination educational module (InTroDuce-Programme) on knowledge and intention for antenatal vaccination: A cluster randomised controlled trial protocol among pregnant women in Malaysian primary care clinics. PLoS One. 2026 Mar 12;21(3):e0344651. doi: 10.1371/journal.pone.0344651. eCollection 2026.

  PMID: 41818225 DERIVED

Related Links

• Centers for Disease Control and Prevention (CDC). (2023). Vaccination During Pregnancy
• PERINATAL CARE MANUAL 4th EDITION. Ministry of Health. 2022

MeSH Terms

Conditions

Tetanus; Diphtheria; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hung Chiun Lau, Dr Fam Med

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung Chiun Lau, Dr Fam Med

CONTACT

+60163502549; hungchiun@upm.edu.my

Siew Mooi Ching, Fam Med

CONTACT

+60193806652; sm_ching@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Lecturer and Family Medicine Specialist

Model Details: web-based educational video on Influenza and Tdap vaccine (InTroDuce-Programme)

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)