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IRCT20141209020258N139 IRCT 2020-04-02 Arak University of Medical Sciences The effect of counselling on self-efficacy of breast-feeding in gestational diabetes Comparing the effect of self-efficacy counselling and routine care on self-efficacy of breast-feeding in women with gestational diabetes 2019-09-23 anticipated 100 Complete https://irct.ir/trial/46347 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple individual randomization; randomization with envelopes and allocating into two groups A and B. In this method, we select a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards are mixed. One card is taken out and its ‎allocation is registered and the card is returned to the box near other cards. Then the cards ‎are mixed again and we take out another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping. Groups are named as A and B and will be available to analyzer and outcome assessor using these codes. 3 Gestational diabetes. Intervention 1: Intervention group: The intervention group will receive self-efficacy sessions as GATHER counseling in 6 sessions that will receive 2 sessions in the third trimester of pregnancy (first session between 32 to 33 weeks and the second session between 35 to 36 weeks and 4 postpartum sessions with intervals of 14 to 16 days, 28 to 30 days, two months and three months after delivery). Intervention 2: Control group: The control group will also receive routine care. Yes - There is a plan to make this available What will be shared: Data results When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Katayon Vakilian How to obtain: They have to write letters to the professors and the university Comments:
public Dr Mahbobeh Khorsandi
Midwifery and nursing department, Payambar azam complex, Basij squre, Sardasht, Arak
Arak Iran (Islamic Republic of) 848176941 +98 86 3222 2003 khorsandi@yahoo.com Arak University of Medical Sciences scientific Dr Katayon Vakilian
Midwifery and nursing department, Payambar Azam complex, Basij sqaure, Sardasht, Arak
Arak Iran (Islamic Republic of) 848176941 +98 86 3222 2003 cattyv@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers with gestational diabetes Ages 18 to 40 years Single pregnancy First and second births 18 years 40 years Female Lack of consent to participate in the study Infant hospitalized for more than twelve hours Infant with congenital malformations or metabolic disorders Illiterate mother Severe postpartum complications Having prohibition of lactation O24.4 Gestational diabetes mellitus Treatment - Other Treatment - Other Intervention group: The intervention group will receive self-efficacy sessions as GATHER counseling in 6 sessions that will receive 2 sessions in the third trimester of pregnancy (first session between 32 to 33 weeks and the second session between 35 to 36 weeks and 4 postpartum sessions with intervals of 14 to 16 days, 28 to 30 days, two months and three months after delivery). Control group: The control group will also receive routine care. Self-efficacy of breast-feeding. Timepoint: Before consultation and then every month until 4 months later. Method of measurement: Self-efficacy of breast-feeding questionnaire. Neonate weight gain. Timepoint: Before consultation and then every month until 4 months later. Method of measurement: Scale. Catching fissure. Timepoint: Before consultation and then every month until 4 months later. Method of measurement: Physical examination. Mastitis. Timepoint: Before consultation and then every month until 4 months later. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2019-09-22 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij square ,Sardasht, Arak Arak Markazi Iran (Islamic Republic of)