A Randomized Control Study to Investigate the Effectiveness of Childhood Immunization Education Program for Parents in the Perinatal Period

UMIN ID: UMIN000012575

Registered date:18/12/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: women during perinatal period
• Date of first enrollment: 2013/12/18
• Target sample size: 175
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention In addition to the usual perinatal checkups and health education, the participants in an intervention group receive both (1) and (2). If possible, participant's husband (partner) or family would also be present in the sessions. (1) During late pregnancy, pregnant women who visit prenatal check-up receive individual immunization education for 10 min. (2) At one-month postpartum checkup, postpartum women are supposed to check whether being prepared to receive immunization for 3-5 min.
Control The participants in a control group receive the usual perinatal checkups and health education.

Outcome(s)

• Primary Outcome: An immunization up-to-date status when the infant is at three months of age for HBV vaccine
• Secondary Outcome: An immunization up-to-date status when the infant is at three months of age for Rotavirus vaccine, Hib vaccine, and PCV13 Parental discussion about vaccinations Looking for the primary physician for receiving vaccinations A change in maternal intention to receive immunization, knowledge, attitudes and beliefs, and health literacy between the pre-study evaluation and post-study evaluation

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: Correspond to any of the following (1) It is predicted that birth weight is estimated at less than 2000g due to intrauterine growth restriction (IUGR), or others. (2) It is predicted that there is need for newborn hospitalization for more than one month. (3) Those who are judged not capable of participating in the study by the obstetrician or midwife and nurse

Related Information

• Primary Sponsor: Graduate School of Medicine, The University of Tokyo
• Source(s) of Monetary Support: Pfizer Health Research Foundation