NCT07461038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 2, 2026

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Maternal Breastfeeding Self-Efficacy

    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

    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 Outcomes (4)

  • Coparenting Perception Level

    6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum

  • Breastfeeding Type

    6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum

  • Neonatal Weight Gain

    6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum

  • Duration of Jaundice

    6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum

Study Arms (4)

Full-stage Parental Involvement Group (A)

EXPERIMENTAL

Perinatal (14 weeks gestation to 24 weeks postpartum) parental joint breastfeeding support

Behavioral: Parental Involvement in Breastfeeding Support

Prenatal Parental Involvement Group (B)

EXPERIMENTAL

Prenatal (14 weeks gestation to delivery) parental joint breastfeeding support, postpartum maternal-only support

Behavioral: Parental Involvement in Breastfeeding Support

Postpartum Parental Involvement Group (C)

EXPERIMENTAL

Prenatal maternal-only support, postpartum (delivery to 24 weeks) parental joint breastfeeding support

Behavioral: Parental Involvement in Breastfeeding Support

Maternal-only Support Group (D)

ACTIVE COMPARATOR

Postpartum maternal-only routine breastfeeding guidance

Behavioral: Maternal-only Breastfeeding Support

Interventions

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).

Full-stage Parental Involvement Group (A)Postpartum Parental Involvement Group (C)Prenatal Parental Involvement Group (B)

Routine postpartum breastfeeding guidance provided only to mothers (no paternal involvement), including basic breastfeeding skill training and regular follow-up.

Maternal-only Support Group (D)

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Women's and Children's Hospital

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 2, 2026

First Posted

March 10, 2026

Study Start

August 20, 2020

Primary Completion

October 20, 2020

Study Completion

October 20, 2020

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations