- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461038
Effects of Spousal Participation in Breastfeeding Interventions at Different Perinatal Stages on Mothers' Coparenting Cognition and Infant Feeding Patterns
The Effects of Spousal Participation in Breastfeeding Interventions at Different Perinatal Stages on Mothers' Coparenting Cognition and Infant Feeding Patterns: A Prospective Quasi-Experimental Study
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear.
Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being.
Aim: This study aimed to examine the effects of spousal participation in breastfeeding interventions at different perinatal stages on maternal co-parenting perceptions and infant feeding practices for full-term infants.
Methods: Pregnant women who received antenatal care and delivered at our hospital, together with their partners, were recruited and categorized by the timing of partner involvement in breastfeeding activities: both antenatal and postnatal (Group A); antenatal only (Group B); postnatal only (Group C); and no antenatal education but routine postnatal guidance (Group D). Maternal breastfeeding self-efficacy and coparenting perception were assessed at 6, 12, and 24 weeks postpartum.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710061
- Northwest Women's and Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Married couples, with gestational age between 12 - 14 weeks at enrollment for Groups A and B;
- Planned discharge within 48 hours after delivery;
- Mothers and partners expected to cohabit for ≥6 months postpartum;
- Gestational age at delivery ≥37 weeks;
- No diagnosed psychiatric disorders in either partner;
- Voluntary participation with written informed consent from both mother and partner;
- Neonates with Apgar scores ≥8 at 1, 5, and 10 minutes after birth.
Exclusion Criteria:
- Maternal diagnosis of infectious diseases (e.g., HIV, hepatitis B);
- Withdrawal from the study at any stage;
- Failure to complete required questionnaires;
- Loss to follow-up during the study period;
- Concurrent participation in other interventional studies;
- Major fetal anomalies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Full-stage Parental Involvement Group (A)
Perinatal (14 weeks gestation to 24 weeks postpartum) parental joint breastfeeding support
|
Multistage breastfeeding support involving fathers: prenatal education (14-37 weeks gestation, including manuals and videos), intrapartum 'three early' practices (skin-to-skin contact, early suckling, early milk initiation), and postpartum follow-up (48 hours to 24 weeks, including activity records, QR code resources, and weekly follow-up).
|
|
Experimental: Prenatal Parental Involvement Group (B)
Prenatal (14 weeks gestation to delivery) parental joint breastfeeding support, postpartum maternal-only support
|
Multistage breastfeeding support involving fathers: prenatal education (14-37 weeks gestation, including manuals and videos), intrapartum 'three early' practices (skin-to-skin contact, early suckling, early milk initiation), and postpartum follow-up (48 hours to 24 weeks, including activity records, QR code resources, and weekly follow-up).
|
|
Experimental: Postpartum Parental Involvement Group (C)
Prenatal maternal-only support, postpartum (delivery to 24 weeks) parental joint breastfeeding support
|
Multistage breastfeeding support involving fathers: prenatal education (14-37 weeks gestation, including manuals and videos), intrapartum 'three early' practices (skin-to-skin contact, early suckling, early milk initiation), and postpartum follow-up (48 hours to 24 weeks, including activity records, QR code resources, and weekly follow-up).
|
|
Active Comparator: Maternal-only Support Group (D)
Postpartum maternal-only routine breastfeeding guidance
|
Routine postpartum breastfeeding guidance provided only to mothers (no paternal involvement), including basic breastfeeding skill training and regular follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Breastfeeding Self-Efficacy
Time Frame: 6 weeks postpartum, 12 weeks postpartum, 24 weeks postpartum
|
Measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).
This 14-item scale uses a 5-point response scale (1 = not confident at all, 5 = completely confident), with a total score ranging from 14 to 70.
Higher scores indicate stronger breastfeeding self-efficacy.
Measured at 6, 12, and 24 weeks postpartum.
|
6 weeks postpartum, 12 weeks postpartum, 24 weeks postpartum
|
|
Spousal Involvement Frequency in Breastfeeding
Time Frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Recorded via a self-designed activity log, including spousal assistance in breastfeeding preparation, positioning, and follow-up.
|
6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coparenting Perception Level
Time Frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Measured by the Brief Coparenting Relationship Scale (Brief-CRS).
This 14-item scale uses a 6-point response scale (0 = completely disagree, 6 = completely agree), with a total score ranging from 0 to 84.
Higher scores indicate better coparenting coordination between parents.
Measured at 6, 12, and 24 weeks postpartum.
|
6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
|
Breastfeeding Type
Time Frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Categorized as exclusive breastfeeding, mixed feeding, or formula feeding, based on maternal self-report.
|
6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
|
Neonatal Weight Gain
Time Frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Recorded as the change in neonatal body weight (in kilograms) from birth to each follow-up time point, based on clinical follow-up records.
|
6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
|
Duration of Jaundice
Time Frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Recorded as the number of days from the onset of neonatal jaundice to its complete resolution, based on clinical follow-up records.
|
6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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