An interventional study of Shared Decision-Making Counseling in Breastfeeding Outcomes and Decisional Conflict, sponsored by Zahedan University of Medical Sciences. Completed at 1 site in Iran. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Zahedan University of Medical Sciences · Not applicable, Interventional, and Supportive care
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 112 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Zahedan University of Medical Sciences is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:-Irani
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Shared Decision-Making Counseling
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.
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.
Time frame: 3 days postpartum and 60 days postpartum
Decisional Conflict Scale (DCS) score
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.
Time frame: Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum
Plan to share: No — 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.
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Aug 2025, 7 months.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 7 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Zahedan University of Medical Sciences