Clinical trial NCT03863444: Effects of Prenatal Preparation Education on First-time Parents
Official title: I-Yuan Yen, Registered Nurse Department of Nursing, National Taiwan University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Partner, Domestic
Keywords: First-time Parents
Prenatal Preparation Education
Partner Support
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be divided into the experimental group and control group. In order to avoid the contamination between the control group and the experimental group due to the simultaneous empty space and information sharing, the control group will be recruited in the study in the first two months. After control group recruitment, we will recruit the intervention group and provide prenatal education.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
measure: Changes of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
measure: Changes of Postpartum Partner Support Scale (PPSS)
timeFrame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
measure: Changes of Maternal Attachment Inventory (MAI)
timeFrame: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
measure: Changes of Difficulty in Baby-Care Activities Scale (DIBCAS)
timeFrame: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
Secondary outcomes:
measure: Social Support Scale (SSS)
timeFrame: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
measure: Center for Epidemiologic Studies Depression Scale (CES-D) - Short Form
timeFrame: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
measure: Background and Obstetric/Breastfeeding Information Form (BOBIF)
timeFrame: Background information of parents will be assessed at Gestational Week 35~39 (T1). Obstetric and breastfeeding information will be assessed at postpartum 3~5 days (T2).
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: I-Yuan Yen, MS
role: PRINCIPAL_INVESTIGATOR
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