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IRCT2016101710324N34 IRCT 2017-02-20 Vice chancellor for research, Tabriz University of Medical Sciences The effect of metoclopramide administration to mother on newborn’s bilirubin and mother’s prolactine The effect of metoclopramide administration to mother on newborn’s bilirubin and mother’s prolactine: a randomized controlled clinical trial 2017-01-20 anticipated 112 Complete https://irct.ir/trial/10809 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, participants, assessor and data analyzer will be blinded from type of intervention. 2-3 prevention of neonatal jaundice and increasing the volum of breast milk. Intervention 1: The intervention group will receive Metoclopramide tablet, 10 mg three times per day for five days. Intervention 2: The control group will receive 10 mg placebo tablet three times per day for five days.
public Shirin Osouli Tabrizi
Faculty of Nursing & Midwifery, South Shariati street
Tabriz Iran (Islamic Republic of) 00984166156156 00 shirin.osouli@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41347967700 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Healthy full-term pregnancy; Mothers with singleton pregnancy; Being Lactating, and having tendency and motivation to breast-feeding; Living in Tabriz; Willingness to continue in the study; -Having at least literacy of reading and writing. Exclusion criteria: Newborns with birth defects; Newborns that need to neonatal intensive cares; Neonatal jaundice in first day after birth; Neonatal metabolic disease; Taking of hormonal drugs by mothers such as estrogen; Taking of medications that affect the serum prolactin like halopridol, reserpine, mytel- dopa, opiates and cimetidine; Maternal depression; History of previous depression; Inverted nipple; Having absolute or relative contraindication for breast-feeding in the mother including diseases such as untreated TB, infection with HIV, CMV, herpes simplex virus and hepatitis and taking of radioactive drugs and illegal drugs during the breastfeeding period, such as methotrexate, lithium, cyclophosphamide, hydroxyurea, phencyclidine, phenidone, opiate substances and metronidazole; History of chronic disease in the mother 15 years 49 years Female P59.9 Neonatal jaundice, unspecified Treatment - Drugs Placebo The intervention group will receive Metoclopramide tablet, 10 mg three times per day for five days The control group will receive 10 mg placebo tablet three times per day for five days. Newborn’s bilirubin. Timepoint: Before intervention and sixth day after the intervention. Method of measurement: TCB. Mother’s prolactin serum level. Timepoint: Next day after starting of the intervention and sixth day. Method of measurement: Prolactin ELISA Kit. Volume of breast milk. Timepoint: Two hours after the last breastfeeding in the first and sixth day of intervention. Method of measurement: Syringe. Satisfaction from breastfeeding status. Timepoint: After the end of intervention. Method of measurement: Satisfaction checklist. Vice chancellor for research, Tabriz University of Medical Sciences Approved 2016-12-26 Ethics committee of Tabriz Univercity of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan Tabriz Iran (Islamic Republic of)