NCT07430020

Shared Decision-Making Counseling and Breastfeeding Performance Among Primiparous Women in Iran

Effect of Prenatal Shared Decision-Making Counseling on Decisional Conflict and Breastfeeding Performance Among Primiparous Women: A Quasi-Experimental Embedded Mixed-Methods Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Zahedan University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This quasi-experimental embedded mixed-methods study evaluated the effect of a prenatal shared decision-making (SDM) counseling session on decisional conflict and breastfeeding performance among primiparous women in Zahedan, Iran. A total of 112 pregnant women at 35-37 weeks' gestation were allocated to either an intervention group receiving one 90-minute SDM counseling session or a control group receiving routine prenatal care. Decisional conflict was assessed at baseline, one week post-intervention, and three days postpartum. Breastfeeding performance was evaluated on days 3 and 60 postpartum.

Detailed description

This interventional quasi-experimental study with an embedded qualitative component was conducted among primiparous pregnant women in Zahedan, Iran. The quantitative phase included 112 participants recruited at 35-37 weeks of gestation and assigned to either a shared decision-making (SDM) counseling group or a routine care control group. The intervention consisted of a single 90-minute individualized prenatal SDM counseling session conducted according to the three-step SDM model (choice talk, option talk, and decision talk). The session addressed infant feeding options, benefits and risks of exclusive breastfeeding, clarification of maternal values and preferences, and available support systems. The primary outcome was decisional conflict measured using the 16-item Decisional Conflict Scale (score range 0-100). Secondary outcomes included breastfeeding performance measured using the 7-item Breastfeeding Performance Index at 3 and 60 days postpartum. An embedded qualitative grounded theory component explored sociocultural and personal processes influencing infant feeding decisions among participants.

Conditions

• Breastfeeding Outcomes
• Decisional Conflict

Interventions

Type	Name	Description
BEHAVIORAL	Shared Decision-Making Counseling	Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-08-15
• Completion: 2025-10-15
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Iran