Effects of Prenatal Preparation Education on First-time Parents

National Taiwan University

Status: Unknown

Conditions: Parenting; Partner, Domestic

Treatments: Other: Prenatal Preparation Education; Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT03863444

201810089RINA

Details and patient eligibility

About

Background: In 2001, the National Health Service of the Ministry of Health and Welfare promoted breastfeeding by adopting the ten measures of successful breastfeeding. However, there is still much room for improvement in Taiwan's continued breastfeeding rate. Currently, although the breastfeeding education is given since pregnancy, the postpartum women were still suffering from baby's and themselves demands, such as unfamiliar with breastfeeding skills, fatigue, discomfort. When the baby is crying, I don't know how to comfort, and I need help from others. The nursing staff cannot provide immediate assistance due to busy clinical work. It showed that it is very important to include the partners to provide assistance and support to postpartum women. The prenatal education for partners is the opportunity to elevate the partners' ability of baby care and support to mothers.

Purpose: The purpose of this study is to explore whether different prenatal education courses increase the ability of prospective parents to breastfeed, infant care, and support, thereby improving the preparation and quality of life in the early postpartum period, reducing the incidence of postpartum depression, promoting the parenting of newborns, and Attachment Study design: This study adopts a class of experimental design, the study recruited pregnant women 35 to 39 weeks of primipara and their spouses, the study subjects were divided into experimental group and control group, calculated by G*Power software, alpha is set as 0.05 while power as 0.8. It should be 51 pair of parents in two groups in the third time point. Considering the possible attrition, the investigators will recruit 80 pairs of the experimental group and the control group, respectively. Data collection was conducted on the structured questionnaire on the prenatal, early postpartum, and one month postpartum to explore the effectiveness of different prenatal education courses for primiparas and their partners.

Expected outcome: The prenatal education is expected to elevate the partners' ability of baby care and support to mothers in early postpartum, to decrease postpartum blue, and to promote the attachment between parents and newborns. The results of the questionnaire will be analyzed using descriptive statistics and inferential statistical analysis using the suite software SPSS 15.0 for Windows.

Full description

This study adopts a quasi-experimental design. Eligible subjects are pregnant women 35 to 39 weeks of primipara and their spouses. Specifically, inclusion criteria are (1) gestational age 35 to 39 weeks, (2) adults, (3) primipara and their spouses, (4) having routine prenatal visits and plan to have birth in the medical center, (5) able to communicate with Mandarin or Taiwanese, and (6) willing to participate in this study and give written inform-consent forms. Exclusion criteria are (1) having fetus with abnormality, (2) high-risk pregnancy, and (3) cannot room-in due to newborn's medical conditions. Participants would be assessed on the time points of recruitment (T1), early postpartum during hospitalization (T2), and one-month postpartum (T3).

Before conducting this study, the institutional review board (IRB) has approved this study. The research staffs will approach potential participants during their prenatal visits and invite them to participate in the study. Potential participants would be informed of the study purposes, interventions (routine care for control group, routine care plus intervention for intervention group), and interview contents. After written consent is obtained, the interventions will be arranged. In order to control the quality of data collection, the investigators will train the research assistants. Research training will include ethical concerns about collection of research data, methods of approaching eligible subjects, interviewing techniques, and pilot testing of data collection. The training will provide research assistants by the PI and Co-PI of this study.

Enrollment: 320 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• (1) gestational age 35 to 39 weeks
• (2) adults
• (3) primipara and their spouses
• (4) having routine prenatal visits and plan to have the birth in the medical center
• (5) able to communicate with Mandarin or Taiwanese
• (6) willing to participate in this study and give written inform-consent forms

Exclusion criteria

• (1) having fetus with abnormality
• (2) high-risk pregnancy
• (3) cannot room-in due to newborn's medical conditions

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Routine Care

Treatment:

Other: Routine care

Intervention Group

Experimental group

Description:

Routine Care + Prenatal Preparation Education

Treatment:

Other: Routine care

Other: Prenatal Preparation Education