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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07430020
Acronym
SDM
Enrollment
112
Registered
2026-02-24
Start date
2025-01-15
Completion date
2025-10-15
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding Outcomes, Decisional Conflict

Keywords

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

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.

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.

Interventions

BEHAVIORALShared Decision-Making Counseling

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

Sponsors

Zahedan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding Performance Index (BPI) score3 days postpartum and 60 days postpartumBreastfeeding 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

MeasureTime frameDescription
Decisional Conflict Scale (DCS) scoreBaseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartumDecisional 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026