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

February 23, 2026 updated by: Zahra Moudi, Zahedan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Sistan and Baluchestan
      • Zahedan, Sistan and Baluchestan, Iran, 9816675595
        • conducted at comprehensive health centers in Zahedan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:-Irani

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Routine Prenatal Care
Pregnant women received routine prenatal care without shared decision-making counseling.
Behavioral: Shared Decision-Making Counseling
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.
Experimental: Experimental: Shared Decision-Making Counseling
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.
Behavioral: Shared Decision-Making Counseling
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Performance Index (BPI) score
Time Frame: 3 days postpartum and 60 days postpartum
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale (DCS) score
Time Frame: Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum
Decisional conflict will be measured using the Decisional Conflict Scale (DCS). The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahedan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDM-BF-2024-ZAUMS
  • IR.ZAUMS.REC.1403.405 (Other Identifier: Zahedan University of Medical Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) collected during the study will not be shared. The data contain confidential health information and were collected under ethical approval that does not permit public data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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