Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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18 March 2019 |
Main ID: |
ISRCTN48536064 |
Date of registration:
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08/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness of supportive parenting educational programme
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Scientific title:
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Effectiveness of supportive educational parenting programme on parental outcomes in Singapore: a
randomized controlled trial
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Date of first enrolment:
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01/08/2016 |
Target sample size:
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118 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN48536064 |
Study type:
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Interventional |
Study design:
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Randomised controlled trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Shefaly
Shorey |
Address:
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Level 2
Clinical research centre Block MD 11
10 Medical Drive
117597
Singapore
Singapore |
Telephone:
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+65 (0)6601 1284 |
Email:
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nurssh@nus.edu.sg |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 21 years and over 2. Able to read and speak English 3. Low-risk singleton pregnancy at more than 28 weeks of gestation 4. Have a smartphone with internet access 5. Plan to stay in Singapore for first three months after giving birth
Exclusion criteria: 1. Physical or mental disorders which would interfere with their ability to participate in the study 2. High-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc. 3. Complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother 4. Give birth to a new-born at stillbirth or a new-born with congenital anomalies and/or medical complications
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postpartum care Pregnancy and Childbirth Postpartum care
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Intervention(s)
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Participants are randomised to one of two groups using a research randomizer. The participants will be asked to randomly pick a number (retrieved from the randomizer) from an opaque envelope and based on that number they will be randomly divided into intervention group or control group. If both parents/couples (pregnant woman and her partner) are willing to participate in the study and complete the consent procedure, demographic and baseline data will be collected using self-administering questionnaires (PES, PEIBQ, PSSP, EPDS, STAI & WPBL).
Control group Participants receive standard care, which involves postnatal support by the doctors, nurses and lactation consultants from the hospital and follow-up appointment with the obstetrician at one to four weeks post child birth.
Intervention group Participants receive the Supportive Educational parenting Programme (SEPP). The SEPP involves: 1. A 30 minute face-to-face or telephone educational session during pregnancy (after 28 weeks of gestation) 2. A 90 minute face-to face or telephone education after the childbirth for the new parents 3. One month access to the Mobile Health Application (M-Health App). The telephone educational session during the pregnancy will cover topics on parental bonding, expectations in the immediate postpartum period and emotional needs of parents both during pregnancy and after the childbirth. The telephone educational session after the childbirth will cover topics on parental bonding, expectations in the immediate postpartum period, parenting self-efficacy, depression, and social support. The features of the M-Health App include: 1. Knowledge-based information on baby and mother care (audio & video files) 2. Daily push notifications on what to expect about baby’s development in first 4 weeks post childbirth
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Primary Outcome(s)
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Parenting self-efficacy is measured using the Parenting Efficacy Scale (PES) at baseline, post-natal (before hospital discharge), 4 weeks post-natal and 12 weeks post-natal.
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Secondary Outcome(s)
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1. Parental bonding is measured using the Parent-to-Infant Bonding Scale (PIBQ) at baseline, post-natal (before hospital discharge), 4 weeks post-natal and 12 weeks post-natal 2. Social support is measured using the Perceived Social Support for Parenting (PSSP) questionnaire at baseline, post-natal (before hospital discharge), 4 weeks post-natal and 12 weeks post-natal 3. Parenting satisfaction is measured using the Parenting Satisfaction (What Being The Parent of a Baby is Like) (WPBL) questionnaire at baseline, post-natal (before hospital discharge), 4 weeks post-natal and 12 weeks post-natal 4. Postnatal Depression and Anxiety are measured using the Edinburgh Postnatal Depression Scale (EPDS) and the State Trait Anxiety Inventory (STAI-Form Y-1 & Form Y-2) at baseline, post-natal (before hospital discharge), 4 weeks post-natal and 12 weeks post-natal 5. Cost-effectiveness of SEPP as compared to routine perinatal care Health Services Used Due to Maternal and/or Infant Related Health Issues and cost-effectiveness of SEPP compared to routine perinatal care are measured using the Healthcare Services Utilization and Programme-related Expenses Sheet (HSUPES) 4 and 12 weeks post-natal
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Secondary ID(s)
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NUHSRO/2016/023/CRG/02
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Source(s) of Monetary Support
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National University Health System Clinician Research Grant
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Ethics review
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Status:
Approval date:
Contact:
National Health Group, Domain Specific Review Board: NHG DSRB, 07/07/2016, ref: 2016/00651
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/12/2018 |
URL:
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