ParentingNCT03863444
Effects of Prenatal Preparation Education on First-time Parents
A study testing Prenatal Preparation Education and Routine care in people with Parenting and Partner, Domestic, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Partner, Domestic
- What is being tested?
- Prenatal Preparation Education and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (1) having fetus with abnormality
- (2) high-risk pregnancy
- (3) cannot room-in due to newborn's medical conditions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: I-Yuan Yen, Registered Nurse Department of Nursing, National Taiwan University Hospital
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.
Read the 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.
- Conditions
- Parenting, Partner, Domestic
- Being tested
- Prenatal Preparation Education, Routine care
- Keywords
- First-time Parents, Prenatal Preparation Education, Partner Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Preparation EducationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Routine Care Receives: Other: Routine care |
| Intervention Group | Experimental | Routine Care + Prenatal Preparation Education Receives: Other: Prenatal Preparation Education; Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Iowa Infant Feeding Attitude Scale (IIFAS)
The Iowa Infant Feeding Attitude Scale (IIFAS) measured the parents' attitude toward infant feeding with 17 Likert's scale items (Ho \& McGrath, 2011). Each item scored from 1 to 5 (1 = strongly disagree, 5 = strongly agree). Items 1, 2, 4, 6, 8, 10, 11, 14, and 17 will be reversed code. The higher score indicated the higher intention to choose breastfeeding; lower scores indicated the intention to choose formula feeding. Cronbach's alpha is 0.75.
Measured: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Changes of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
The Breastfeeding Self-Efficacy Scale-Short Form measured the breastfeeding self-efficacy with 14 Likert's scale items (Dennis, 2003). Each item scored from 1 to 5 (1 = not at all confident, 5 = always confident). The total scores range from 14 to 70. The higher score indicates the higher levels of breastfeeding self-efficacy.
Measured: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Changes of Postpartum Partner Support Scale (PPSS)
The Postpartum Partner Support Scale (PPSS) measured the prenatal/postpartum partner support perceived by postpartum women and reported by the partners with 20 Likert's scale items (Dennis, Brown, \& Brennenstuhl, 2017). Each item scored from 1 to 4 (1 = strongly disagree, 4 = strongly agree). One item will be reverse-coded. The total score ranges from 20 to 80. The higher score indicated the higher postpartum partner support perceived by postpartum women or the partners. For T1, the description of measure item has been mild-modified to better reflect the prenatal status.
Measured: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Changes of Maternal Attachment Inventory (MAI)
The Maternal Attachment Inventory (MAI) measured the maternal/paternal-infant attachment with 26 items (Lai, 2009; Muller, 1994). Each item scored from 1 to 4 (1 = rarely, 4 = almost). The higher score indicated the better attachment between the mother and the infant. Cronbach's alpha is 0.97.
Measured: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
Changes of Difficulty in Baby-Care Activities Scale (DIBCAS)
The Difficulty in Baby-Care Activities Scale (DIBCAS) measured the difficulties that parents faced in the baby-care activities (Lai, 2009). The 14 items included four aspects: infant feeding, clean \& comfort, safe \& healthy, and smoothing behaviors. Each item scored from 1 to 4 (1 = no difficulty at all; 2 = a little bit difficult, 3 = difficult, 3 = totally difficult). The higher score indicated the higher difficulty level the parents faced in baby-care activities. The Cronbach's alpha of the total scale is 0.91
Measured: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
Secondary outcomes (3)
Social Support Scale (SSS)
The Social Support Scale (SSS) measured the social support perceived by the parents from their families and friends with 10 Likert's scale items (Hung, Stocker, \& Hsu, 2014). Social support is one of the control variables in this study. Each item scored from 1 to 5 (1 = never and 5 = always). The total score ranges from 10 to 50. The higher score indicated the better social support from families and friends. Cronbach's alpha is 0.92 for the whole scale and are 0.70-0.81 for subscales. Item-to-total correlations are 0.38-0.69. Factor analysis showed the two-factor structure, supporting the construction validity.
Measured: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Center for Epidemiologic Studies Depression Scale (CES-D) - Short Form
The Short Form of the Center for Epidemiologic Studies Depression Scale (CES-D-SF) measured severity of depressive symptom during the past week with 10 items (Lee, Ou, Chen, \& Weng, 2009). Each item scored from 0 to 3 (0 = Rarely or none of the time [less than one day]; 1 = Some or a little of the time [1-2 days]; 2 = Occasionally or a moderate amount of time [3-4 days]; 3 = Most or all of the time [5-7 days]). Positive items will be reverse-coded. The total score ranges from 0 to 30. The higher score indicated the more severe depressive symptoms. Cronbach's alpha is 0.86.
Measured: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Background and Obstetric/Breastfeeding Information Form (BOBIF)
In addition background data of the new parents (age, education, marriage status, whether this pregnancy was planned, employment, family income), obstetric and breastfeeding information, including childbirth type, gestation week in birth, immediately skin-to-skin tough after birth, rooming-in type, feeding type, will also collected from medical records by research staffs.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start25 Feb 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Yuan Yen, MS, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863444
- Sponsor's protocol ID
- 201810089RINA
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14649593Dennis 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.
PubMed 28780475Ho 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.
PubMed 20961544Hung 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.
PubMed 24360779Lai, 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.
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
Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
PubMed 7780768
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-Yuan Yen, Registered Nurse Department of Nursing, National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT03863444
- Acronym / sponsor ID
- 201810089RINA
- Conditions
- Parenting, Partner, Domestic
- Keywords
- First-time Parents, Prenatal Preparation Education, Partner Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Routine careRoutine Care |
| Intervention Group | Experimental | Other: Prenatal Preparation Education, Other: Routine careRoutine Care + Prenatal Preparation Education |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (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
Key exclusion criteria (3 listed)
- (1) having fetus with abnormality
- (2) high-risk pregnancy
- (3) cannot room-in due to newborn's medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal Preparation EducationIntervention, 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. | Other | Intervention Group |
| Routine careRoutine 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. | Other | Control Group, Intervention Group |
Primary outcome
Changes of Iowa Infant Feeding Attitude Scale (IIFAS)
Time frame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
The Iowa Infant Feeding Attitude Scale (IIFAS) measured the parents' attitude toward infant feeding with 17 Likert's scale items (Ho \& McGrath, 2011). Each item scored from 1 to 5 (1 = strongly disagree, 5 = strongly agree). Items 1, 2, 4, 6, 8, 10, 11, 14, and 17 will be reversed code. The higher score indicated the higher intention to choose breastfeeding; lower scores indicated the intention to choose formula feeding. Cronbach's alpha is 0.75.
Changes of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Time frame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
The Breastfeeding Self-Efficacy Scale-Short Form measured the breastfeeding self-efficacy with 14 Likert's scale items (Dennis, 2003). Each item scored from 1 to 5 (1 = not at all confident, 5 = always confident). The total scores range from 14 to 70. The higher score indicates the higher levels of breastfeeding self-efficacy.
Changes of Postpartum Partner Support Scale (PPSS)
Time frame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
The Postpartum Partner Support Scale (PPSS) measured the prenatal/postpartum partner support perceived by postpartum women and reported by the partners with 20 Likert's scale items (Dennis, Brown, \& Brennenstuhl, 2017). Each item scored from 1 to 4 (1 = strongly disagree, 4 = strongly agree). One item will be reverse-coded. The total score ranges from 20 to 80. The higher score indicated the higher postpartum partner support perceived by postpartum women or the partners. For T1, the description of measure item has been mild-modified to better reflect the prenatal status.
Changes of Maternal Attachment Inventory (MAI)
Time frame: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
The Maternal Attachment Inventory (MAI) measured the maternal/paternal-infant attachment with 26 items (Lai, 2009; Muller, 1994). Each item scored from 1 to 4 (1 = rarely, 4 = almost). The higher score indicated the better attachment between the mother and the infant. Cronbach's alpha is 0.97.
Changes of Difficulty in Baby-Care Activities Scale (DIBCAS)
Time frame: Parents will be assessed the change between postpartum 3~5 days (T2) and postpartum 1 month (T3).
The Difficulty in Baby-Care Activities Scale (DIBCAS) measured the difficulties that parents faced in the baby-care activities (Lai, 2009). The 14 items included four aspects: infant feeding, clean \& comfort, safe \& healthy, and smoothing behaviors. Each item scored from 1 to 4 (1 = no difficulty at all; 2 = a little bit difficult, 3 = difficult, 3 = totally difficult). The higher score indicated the higher difficulty level the parents faced in baby-care activities. The Cronbach's alpha of the total scale is 0.91
3 secondary outcomes
Social Support Scale (SSS)
Time frame: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Center for Epidemiologic Studies Depression Scale (CES-D) - Short Form
Time frame: Parents will be assessed at Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).
Background and Obstetric/Breastfeeding Information Form (BOBIF)
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Background: PubMed 14649593Dennis 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.
- Background: PubMed 28780475Dennis 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.
- Background: PubMed 20961544Ho 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.
- Background: PubMed 24360779Hung 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.
- BackgroundLai, 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.
- BackgroundLee, 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
- Background: PubMed 7780768Muller ME. A questionnaire to measure mother-to-infant attachment. J Nurs Meas. 1994 Winter;2(2):129-41.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Yuan Yen, MS principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Preparation Education and Routine care in people with Parenting and Partner, Domestic, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Yuan Yen, MS (+886-2-23123456 ext. 71108, iyuanyen@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Iowa Infant Feeding Attitude Scale (IIFAS) (time frame: Parents will be assessed the change among Gestational Week 35~39 (T1), postpartum 3~5 days (T2), and postpartum 1 month (T3).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863444, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.