Breastfeeding OutcomesSDMNCT07430020
Shared Decision-Making Counseling and Breastfeeding Performance Among Primiparous Women in Iran
A study testing Shared Decision-Making Counseling in people with Breastfeeding Outcomes and Decisional Conflict, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Breastfeeding Outcomes, Decisional Conflict
- What is being tested?
- Shared Decision-Making Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIran
- Study dates
- 15 Jan 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Iran1 site
conducted at comprehensive health centers in Zahedan
Zahedan, Sistan and Baluchestan, 9816675595
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding Outcomes, Decisional Conflict
- Being tested
- Shared Decision-Making Counseling
- Keywords
- Shared decision-making, Primiparous women, Prenatal counseling, Breastfeeding performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision-Making CounselingBehavioural
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Routine Prenatal Care | Active comparator | Pregnant women received routine prenatal care without shared decision-making counseling. Receives: Behavioral: Shared Decision-Making Counseling |
| Experimental: Shared Decision-Making Counseling | Experimental | Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care. Receives: Behavioral: Shared Decision-Making Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days postpartum and 60 days postpartum
Secondary outcomes (1)
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.
Measured: Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start15 Jan 2025
- Primary completion15 Aug 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Moudi, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430020
- Sponsor's protocol ID
- SDM-BF-2024-ZAUMS
- Other IDs
- IR.ZAUMS.REC.1403.405
- Acronym
- SDM
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prenatal Shared Decision-Making Counseling on Decisional Conflict and Breastfeeding Performance Among Primiparous Women: A Quasi-Experimental Embedded Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07430020
- Acronym / sponsor ID
- SDM / SDM-BF-2024-ZAUMS
- Conditions
- Breastfeeding Outcomes, Decisional Conflict
- Keywords
- Shared decision-making, Primiparous women, Prenatal counseling, Breastfeeding performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Routine Prenatal Care | Active comparator | Behavioral: Shared Decision-Making CounselingPregnant women received routine prenatal care without shared decision-making counseling. |
| Experimental: Shared Decision-Making Counseling | Experimental | Behavioral: Shared Decision-Making CounselingPregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Primiparous pregnant women
- Gestational age between 35 and 37 weeks at enrollment
- Singleton pregnancy
- First breastfeeding experience
- Planned delivery in Zahedan hospitals
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision-Making CounselingPregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care. | Behavioural | Experimental: Shared Decision-Making Counseling, Routine Prenatal Care |
Primary outcome
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.
1 secondary outcome
Decisional Conflict Scale (DCS) score
Time frame: Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision-Making Counseling in people with Breastfeeding Outcomes and Decisional Conflict, run by Zahedan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Performance Index (BPI) score (time frame: 3 days postpartum and 60 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.