Can involving partners in breastfeeding counselling help first-time mothers breastfeed exclusively for six months?

ISRCTN	ISRCTN54832662
DOI	https://doi.org/10.1186/ISRCTN54832662
National Medical Research Register	RSCH ID-26-04218-8KZ
Sponsor	University Malaya Medical Centre
Funder	Department of Medicine, University of Malaya

Submission date: 26/06/2026
Registration date: 26/06/2026
Last edited: 26/06/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chieng Han Ling
Public, Principal investigator, Scientific

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone	+60 03-79494422
Email	lingchienghan@ummc.edu.my

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care
Scientific title	Partner-inclusive postpartum counselling versus breastfeeding friendly hospital initiative (BFHI) standard care to improve six-month exclusive breastfeeding among primiparous women
Study objectives
Ethics approval(s)	Approved 30/04/2026, UMMC Medical Research Ethics Committee (UMMC-MREC) (University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur, 59100, Malaysia; +60 03-79493209; ummc-mrec@ummc.edu.my), ref: 20251114-15878
Health condition(s) or problem(s) studied	Improving exclusive breastfeeding at six months among primiparous postpartum women.
Intervention	This is a two-arm, parallel-group randomized controlled trial. Eligible primiparous postpartum women and their partners will be randomly allocated in a 1:1 ratio to either the intervention or control group after providing written informed consent. Intervention group: Participants will receive routine Baby-Friendly Hospital Initiative (BFHI) postpartum care plus a single structured partner-inclusive breastfeeding counselling session before hospital discharge. The session will include a standardized educational video followed by face-to-face discussion with the research team to reinforce key messages, answer questions, and address breastfeeding concerns. Topics include breastfeeding techniques and positioning, common breastfeeding challenges, breast milk expression and storage, and practical and emotional partner support. The session will be delivered once during the postnatal admission. Control group: Participants will receive routine postpartum care according to BFHI standards at University of Malaya Medical Centre without the additional partner-inclusive counselling session. Participants in both groups will complete baseline questionnaires before discharge. Follow-up assessments will be conducted at 3 and 6 months postpartum to assess exclusive breastfeeding status and complete the study questionnaires.
Intervention type	Behavioural
Primary outcome measure(s)	Exclusive breastfeeding at six months postpartum measured using the WHO 24-hour infant feeding recall method at 6 months postpartum
Key secondary outcome measure(s)	Maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale–Short Form (BSES-SF) at baseline, 3 months postpartum, 6 months postpartum Partner breastfeeding attitudes measured using the Iowa Infant Feeding Attitude Scale for Partners (IIFAS-P) at baseline, 3 months postpartum, 6 months postpartum
Completion date	31/12/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	All
Target sample size at registration	214
Key inclusion criteria	1. Primiparous women aged 18 years or older 2. Delivered a healthy singleton term infant (≥37 completed weeks' gestation) 3. Intend to exclusively breastfeed their infant 4. Recruited within 24–48 hours postpartum prior to hospital discharge 5. Able to understand the study information and provide written informed consent 6. Have a partner who is available, willing to participate in the counselling session and follow-up assessments, and able to provide written informed consent
Key exclusion criteria	1. Mothers with medical contraindications to breastfeeding 2. Infants requiring prolonged neonatal intensive care unit (NICU) admission or with significant medical conditions that preclude breastfeeding 3. Mothers or partners unable to understand the study information or communicate in the study languages 4. Mothers or partners with major psychiatric illness, cognitive impairment, or any condition that would limit participation or informed consent 5. Women who screen positive for intimate partner violence (IPV) using the HARK screening tool 6. Partners who are unavailable or unwilling to participate in the counselling session and follow-up assessments
Date of first enrolment	01/07/2026
Date of final enrolment	30/06/2027

Locations

Countries of recruitment

Malaysia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

26/06/2026: Study’s existence confirmed by the Medical Research Ethics Committee, University of Malaya Medical Centre (UMMC-MREC), Malaysia.