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Completed

NCT Number: NCT07430020

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

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.

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Key information

Conditions

Breastfeeding Outcomes Decisional Conflict

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

conducted at comprehensive health centers in Zahedan

Zahedan, Sistan and Baluchestan, 9816675595, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Shared Decision-Making Counseling

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zahedan University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: SDM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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