]>
IRCT20231202060247N2 IRCT 2026-07-04 Bandare-abbas University of Medical Sciences The effect of comprehensive breastfeeding support counseling TCBS The effect of comprehensive breastfeeding support counseling on breastfeeding competence and self-efficacy of primiparous women referring to the women's clinic of Shariati Hospital in 1404-1405: A randomized controlled clinical trial 2026-08-06 anticipated 98 Recruiting https://irct.ir/trial/90516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Participants will be assigned to two intervention and control groups using a block randomization method. The randomization tool will include randomization software to ensure a balanced distribution of confounding variables. To reduce initial differences between groups, a one-to-one matching strategy will also be used. Each participant in the intervention group will be matched with one participant in the comparison group. In addition to the matching strategy, participants will be divided into blocks of 4 or 6 based on common characteristics between individuals. Then, random assignment to groups will be performed in each block. Blocking will be performed by a person not involved in sampling and data analysis, Blinding description: To conceal allocation, participants will select one from a pre-prepared set of sealed envelopes. The inside of each envelope is marked with a label "1" or "2" in a 1:1 ratio. Label "1" will be assigned to the intervention group, while label "2" will indicate the control group. After allocation and matching, participants will be randomly assigned 1:1 to one of the two intervention groups and the control group. In this study, to comply with blinding, patients and outcome assessors will be unaware of the group allocation of participants, and this study will be a double-blind clinical trial. N/A breastfeeding. Intervention 1: Intervention group: Intervention group: For the intervention group, breastfeeding support counseling will be provided in the breastfeeding counseling room located in the obstetrics and gynecology clinic of Shariati Hospital. Accordingly, 6 breastfeeding support counseling sessions will be provided in the two phases of pregnancy and postpartum. The goal of breastfeeding support counseling in the pregnancy phase will be to prepare the mother psychologically and practically for successful breastfeeding, and in the postpartum phase, to successfully start breastfeeding and manage postpartum breastfeeding challenges. Breastfeeding support counseling sessions during pregnancy will be two 45- to 60-minute sessions at 34 and 37 weeks of pregnancy, and in the postpartum period, there will be 4 30- to 45-minute sessions on the first day, first week, second week, and sixth week. In the intervention group In addition to supportive breastfeeding counseling, skin-to-skin contact after delivery will be provided by the researcher in the delivery room or operating room for one hour. In the intervention group, booklets containing the content and timing of supportive breastfeeding counseling will be provided to pregnant mothers in the first session. Intervention 2: Control group: In the control group, breastfeeding counseling will be routinely provided by a lactation consultant at Shariati Hospital. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nasibeh Roozbeh
بندرعباس-ابتدای بلوار امام حسین-شهرک نبوت-پردیس دانشگاه علوم پزشکی
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0393 nasibe62@yahoo.com Bandare-abbas University of Medical Sciences scientific Nasibeh Roozbeh
Bandar Abbas - Beginning of Imam Hossein Boulevard - Nabutov Town - Campus of University of Medical Sciences
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 3930 nasibe62@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Primary birth Age over 18 years Singleton pregnancy and full term Healthy newborn weighing over 2500 grams Ability to read and write Birth at Shariati Hospital, Bandar Abbas Willingness to participate in the study Ability to attend counseling sessions regularly No breast disease No history of chronic diseases No addiction to medication, smoking, drugs, or alcohol 18 years no limit Female Unwillingness to participate in the study Infant contracting diseases incompatible with breastfeeding Having any medical complications during pregnancy or childbirth Women who have conceived using fertility treatments Those at high risk of preterm birth multiple Morbid obesity (BMI > 40) Premature baby (less than 37 weeks) Admission of the baby or mother to the intensive care unit Taking medications that are contraindicated in pregnancy or HIV-positive Fetal abnormalities Low birth weight infants >2500 grams Having a high-risk pregnancy Having medical conditions that prevent breastfeeding Having communication problems Having psychiatric illnesses Behavior Behavior Intervention group: Intervention group: For the intervention group, breastfeeding support counseling will be provided in the breastfeeding counseling room located in the obstetrics and gynecology clinic of Shariati Hospital. Accordingly, 6 breastfeeding support counseling sessions will be provided in the two phases of pregnancy and postpartum. The goal of breastfeeding support counseling in the pregnancy phase will be to prepare the mother psychologically and practically for successful breastfeeding, and in the postpartum phase, to successfully start breastfeeding and manage postpartum breastfeeding challenges. Breastfeeding support counseling sessions during pregnancy will be two 45- to 60-minute sessions at 34 and 37 weeks of pregnancy, and in the postpartum period, there will be 4 30- to 45-minute sessions on the first day, first week, second week, and sixth week. In the intervention group In addition to supportive breastfeeding counseling, skin-to-skin contact after delivery will be provided by the researcher in the delivery room or operating room for one hour. In the intervention group, booklets containing the content and timing of supportive breastfeeding counseling will be provided to pregnant mothers in the first session. Control group: In the control group, breastfeeding counseling will be routinely provided by a lactation consultant at Shariati Hospital. Breastfeeding self-efficacy and breastfeeding competence. Timepoint: 34th week of pregnancy and 6th week postpartum. Method of measurement: Breastfeeding Self-Efficacy Questionnaire - Breastfeeding Competence Questionnaire. Neonatal hyperbilirubin - postpartum hemorrhage - breastfeeding success - postpartum depression - neonatal anthropometric indices (weight, height, head circumference) - pain - wound infection - neonatal hypothermia - breastfeeding continuation - breastfeeding support counseling. Timepoint: Bilirubin level of the newborn on day 3 - Rate of early postpartum hemorrhage (first 24 hours) and rate of late postpartum hemorrhage (first week) - Breastfeeding success score in the first week after delivery - Postpartum depression score in the 6th week after delivery - Anthropometric indices of the newborn (height, weight, head circumference) in the first 24 hours and 6th week after delivery - Pain level in the first 24 hours and the first week after delivery - Rate of wound infection in the first week after delivery - Rate of hypothermia after birth and 24 hours after that - Rate of breastfeeding continuity in the first, second and sixth weeks after delivery. Method of measurement: Maternal and Infant Clinical Assessment Checklist - Maternal and Infant Clinical Assessment Checklist - Edinburgh Postpartum Depression Questionnaire - Anthropometric Index Checklist - Visual Pain Scale Questionnaire - Maternal and Infant Clinical Assessment Checklist - Maternal and Infant Clinical Assessment Checklist - Daily Breastfeeding Success Monitoring Checklist - Breastfeeding Supportive Counseling Sessions. Bandar Abbas University of Medical Sciences Approved 2025-10-29 Ethics Committee of Hormozgan University of Medical Sciences بلوار امام حسین بندرعباس Hormozgan Iran (Islamic Republic of)