Effects of Prenatal Preparation Education on First-time Parents

NCT ID: NCT03863444

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Parenting Partner, Domestic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Routine Care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.

Intervention Group

Routine Care + Prenatal Preparation Education

Group Type EXPERIMENTAL

Prenatal Preparation Education

Intervention Type OTHER

Intervention, provided by researchers, includes video, counseling, and skill practices. Video contains (1) Newborn Reaction, including rooting reflex, correct latch-on posture, assuring newborn having enough milk intakes; (2) Newborn Care, including holding, dipper-changing, clothes-changing, and swaddle the newborn; and (3) Partner Support, including the importance of partner support and the content how partner provide support to the postpartum women. After watching the video, the researcher will provide participants counseling, and then each pair of participants will have skill practice.

Routine care

Intervention Type OTHER

Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.

Interventions

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Prenatal Preparation Education

Intervention, provided by researchers, includes video, counseling, and skill practices. Video contains (1) Newborn Reaction, including rooting reflex, correct latch-on posture, assuring newborn having enough milk intakes; (2) Newborn Care, including holding, dipper-changing, clothes-changing, and swaddle the newborn; and (3) Partner Support, including the importance of partner support and the content how partner provide support to the postpartum women. After watching the video, the researcher will provide participants counseling, and then each pair of participants will have skill practice.

Intervention Type OTHER

Routine care

Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I-Yuan Yen, MS

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

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I-Yuan Yen, MS

Role: CONTACT

+886-2-23123456 ext. 71108

References

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Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

Reference Type BACKGROUND
PMID: 14649593 (View on PubMed)

Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.

Reference Type BACKGROUND
PMID: 28780475 (View on PubMed)

Ho YJ, McGrath JM. A Chinese version of Iowa Infant Feeding Attitude Scale: reliability and validity assessment. Int J Nurs Stud. 2011 Apr;48(4):475-8. doi: 10.1016/j.ijnurstu.2010.09.001. Epub 2010 Oct 18.

Reference Type BACKGROUND
PMID: 20961544 (View on PubMed)

Hung CH, Stocker J, Hsu HT. Comparing Taiwanese women's biopsychosocial features by location of postpartum recovery. Appl Nurs Res. 2014 May;27(2):121-6. doi: 10.1016/j.apnr.2013.11.010. Epub 2013 Nov 11.

Reference Type BACKGROUND
PMID: 24360779 (View on PubMed)

Lai, Y.-I. (2009). Under the policy of mother-baby friendly, postpartum women's fatigue, baby-care activities and maternal-infant attachment with different types of delivery (Unpublished master's thesis) [Traditional Chinese]. College of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.

Reference Type BACKGROUND

Lee, K.-L, Ou, Y.-L., Chen, S.-H., & Weng, L.-J. (2009). The psychometric properties of a short form of the CES-D used in the Taiwan longitudinal study on aging [Traditional Chinese]. Formosa Journal of Mental Health, 22(4), 383-410. doi: 10.30074/cjmh.200912.0002

Reference Type BACKGROUND

Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.

Reference Type BACKGROUND
PMID: 7780768 (View on PubMed)

Other Identifiers

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201810089RINA

Identifier Type: -

Identifier Source: org_study_id

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