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

NCT07430020 | Completed

• 2 other identifiers: SDM-BF-2024-ZAUMSIR.ZAUMS.REC.1403.405
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breastfeeding Outcomes; Decisional Conflict

Keywords

Shared decision-making; Primiparous women; Prenatal counseling; Breastfeeding performance

Outcome Measures

Primary Outcomes (1)

• Breastfeeding Performance Index (BPI) score

  Breastfeeding performance will be assessed using the Breastfeeding Performance Index (BPI). The total score ranges from 0 to 7, with higher scores indicating better breastfeeding performance and greater adherence to exclusive breastfeeding practices.

  3 days postpartum and 60 days postpartum

Secondary Outcomes (1)

• Decisional Conflict Scale (DCS) score

  Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum

Study Arms (2)

Routine Prenatal Care

ACTIVE COMPARATOR

Pregnant women received routine prenatal care without shared decision-making counseling.

Behavioral: Shared Decision-Making Counseling

Experimental: Shared Decision-Making Counseling

EXPERIMENTAL

Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.

Behavioral: Shared Decision-Making Counseling

Interventions

Shared Decision-Making Counseling BEHAVIORAL

Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.

Experimental: Shared Decision-Making Counseling; Routine Prenatal Care

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primiparous pregnant women
• Gestational age between 35 and 37 weeks at enrollment
• Singleton pregnancy
• First breastfeeding experience
• Planned delivery in Zahedan hospitals
• Maternal age between 15 and 40 years
• Receiving care at comprehensive health centers in Zahedan, Iran
• Willingness to participate and provide informed consent

You may not qualify if:

• Contraindications to breastfeeding (e.g., chemotherapy, ergotamines, breast lesions, HIV infection, prenatal depression)
• Preterm birth (\<37 weeks)
• Neonatal intensive care unit (NICU) admission
• Absence from counseling sessions
• Congenital anomalies in the infant (e.g., cleft lip or palate)
• Maternal intensive care unit (ICU) admission
• High-risk pregnancy (e.g., pre-eclampsia/eclampsia, insulin-dependent diabetes, cardiac disease)

Sponsors & Collaborators

• Zahedan University of Medical Sciences: lead

Study Sites (1)

conducted at comprehensive health centers in Zahedan

Zahedan, Sistan and Baluchestan, 9816675595, Iran

Location

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: Professor of Reproductive Health

Model Details: Participants were assigned to two parallel groups. The intervention group received shared decision-making counseling regarding breastfeeding during pregnancy, while the control group received routine prenatal care. Outcomes were compared between the two groups.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 24, 2026
• Study Start: January 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)