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Effect of Domperidone on Lactation in Low Milk Supply Women in Tehran, Iran: a Randomized Clinical Trial

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Effect of Domperidone on Lactation in Low Milk Supply Women in Tehran, Iran: a Randomized Clinical Trial Ulutas Med J 2019;5(3):175-183 DOI: 10.5455/umj.20190502070257 ORIGINAL ARTICLE OPEN ACCESS Effect of Domperidone on Lactation in Low Milk Supply Women in Tehran, Iran: A Randomized Clinical Trial 1 1* 2 3 Saeedeh TarvijEslami ∙ Hosain Nasirian ∙ Arezoo Sadat Razavi ∙ Hamid Zaferani Arani 3 3 3 4 Mahshid Dareh ∙ Poorya Bikarannejad ∙ Yasamin Zivari ∙ Maryam Sadat Motevalli 3 3 Seyed Amirhossein Ahmadi ∙ Elnaz Babakhani 1 Associate Professor, Department of Pediatrics, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran 2 Students’ Research Committee, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran 3 Medical Student, School of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran 4 Master of Public Health (M.P.H.), Health Policy Research Center, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran Background: The promotion of breastfeeding is a simple and efficient strategy in reducing morbidity and mortality among newborns worldwide. Domperidone is a blocker of dopamine receptors, which causes prolactin release. We aimed to determine the efficacy of Domperidone on the amount of breast milk secretion among mothers with low- milk-production. Materials and Methods: This interventional study was performed on 16 consecutive low-milk-producing women who were attending to Azad University Hospitals during 2013-2014. Eligible mothers received Domperidone at a dose of 30 mg orally/day (10 mg tablet three times daily) for a week . Breast-milk volume, as well as the serum levels of prolactin, were determined before and after the intervention. Also, any adverse drug reactions were recorded. Results: The mean breast milk volume was 173.7±47.7 and 326.8±26.1 ml before and after the intervention, respectively. Also, administered of Domperidone cloud significantly increase of %53.1 (p<0.001) in daily milk production. Also, the mean serum prolactin level was 161.1±19.1 and 254±25.5 ng/ml, before and after medications, respectively, which showed a significant increase of %63.46 ( p=0.0001). Conclusion: Domperidone increases the volume of breast milk production among nursing mothers. There was no drug-related side effect for mothers and infants. Keywords: Breastfeeding, domperidone, efficacy, side effects Introduction disease, heart disease, high cholesterol and Head Breast milk is the complete primary blood pressure with a beneficial effect on nutrition for infants with a range of lifelong the cardio-respiratory system in children and benefits for infants' health, growth, immunity, adolescents. Breastfeeding protects against and development as well as for the mothers (1, childhood acute leukaemia, lymphoma, sudden 2). Comparing to formula-fed infants, breastfed infants’ deaths syndrome and is associated with infants may less likely develop juvenile insulin- higher intelligence quotient (IQ), and cognitive dependent diabetes, multiple sclerosis, celiac development (1, 3-7). Some of essential benefits Corresponding Author: Hosain Nasirian; Assoc. Professor, This is an Open Access article distributed under Department of Pediatrics, Tehran Medical Sciences, Islamic the terms of Creative Commons Attribution Non- Azad University, Tehran, Iran Commercial License, which permits unrestricted ORCID: 0000-0002-7756-0829 non-commercial use, distribution, and reproduc- E-mail: [email protected] tion in any area, original work is properly cited. Received: May 2, 2019 Accepted: July 1, 2019 Published: Sep 25, 2019 The Ulutas Medical Journal © 2019 Effect of Domperidone on Women Lactation Tarvij Eslami et al. to the mother are reducing the risk of metabolic Domperidone may increase risk of sudden syndrome, rheumatoid arthritis, and type 2 cardiac death through its prolonging effect on diabetes. Breastfeeding could prevent some cardiac QT-interval and inducing ventricular malignancies (e.g., breast, uterine, endometrial, arrhythmias and is contraindicated in patients and ovarian cancers) in mother (1, 8-11). These with cardiac conditions. QT prolongation in benefits make us responsible for guiding neonates and infants is controversial and nursing mothers to preserve breastfeeding and uncertain (19-22). even encourage adoptive mothers to induce Preliminary data indicate that antifungal lactation (12, 13). drugs, erythromycin, and other macrolides Although breastfeeding rat in Iran is 57%, it is inhibit the metabolism of domperidone and lower than in another country, e.g., 94% in result in enhancing the plasma concentration Tanzania (14). However, some Iranian mothers and potential side effects of those drugs (23- do not have enough breast milk for various 25). Despite some studies revealed the anti- reasons and require using medical and non- dopaminergic drugs on breastfeeding as well as medical methods to increase breast milk (14). mother’s milk volume, the role of domperidone Varying degrees of success have been reported on increase of milk volume, especially Iranian with strategies to increase milk production mothers, is unclear. Considering importance including support, drug therapy, relaxation of breastfeeding, and as domperidone is techniques, mechanical expression. Primary not generally recommended for augmenting data suggest that domperidone may be useful lactation, we aimed to evaluate the effect of in augmenting milk production in women with domperidone in increasing the breast milk low milk supply (15). Dopamine, released by the supply of nursing mothers in Iran. hypothalamus, stops the secretion of prolactin Materials and Methods (stimulating lactation hormone) from pituitary This interventional quasi-experimental (pre- gland. Domperidone is used as an upper post testing) design was carried out on gastrointestinal motility modifier and also by mothers with insufficient lactation in hospitals acting as a peripherally selective antagonist of related to Islamic Azad Universities, Tehran the dopamine D2 and D3 receptors, results in Medical Sciences Branch, Tehran, Iran from increased prolactin-releasing and promotes 2013 to 2014 years. According to the reference lactation as a galactagogue. There are no any number 19 by taking alpha (the first error) 0.05, side effects in infants of breastfeeding mothers d, and p, up to 0.1 and 0.02 respectively, the who using domperidone because minimal sample size in easy sampling was calculated amounts of domperidone (less than 0.2 μg/kg based on the following formula, daily) passed into the breast milk that is related to domperidone's high protein binding (>90 n= (Z1-α/2)² [(P) (1-P)] n= (2)² [(0.02 × 0.98)] n= 8 percentage) and high molecular weight (15-17). d² (0.1)² Some reported adverse reactions include headache (most common), abdominal pain, dry Twenty patients were considered as sample mouth, rash, and trouble sleeping. Restlessness size, ten women with standard delivery, and ten and muscle spasm may rarely occur (18). with the cesarean section. They were screened 176 Ulutas Med J 2019;5(3):175-183 Effect of Domperidone on Women Lactation Tarvij Eslami et al. for enrollment if they had the consent to the amount of milk collected, the date and time. participate in the study, aged 20-35 years, and They were educated and trained to use the low milk production with a gestational age of breast milk pump. Breast milk was expressed by the newborns at>38 weeks, and exclusively mechanical breast milk pump every three hours breastfed infants. (average of six times a day) on the second The women with sensitivity to domperidone, postpartum day, before initiation of study drug side effects, structural anomalies of medication to obtain the baseline (pretest) milk the breast, previous breast surgery, and volume, and the quantity was measured to mothers and infants with illness, mothers with the millilitre. As well as fasting serum levels work pressures, poor nutrition, psychological of prolactin concentrations were determined problems, prolactin-secreting pituitary tumor, using the ELISA kit before the beginning of the gastrointestinal bleeding, liver disease, and initial dose of the drug. For all the blood using the drugs that having interaction with samples, the laboratory was the same. domperidone were excluded from study. In Eligible mothers received domperidone at a the case of mothers with twins or more, the dose of 30 mg orally per day (10 mg tablet three mother with a history of suspected cardiac times daily) for a week, and they were instructed dysrhythmias, and current cigarette smoking to record any adverse drug reaction during (that diminishes prolactin levels) (17, 26). The medication, abdominal pain, mainly dry mouth, population of interest was puerperal women headache, nausea, and diarrhoea. Drug who had experienced postpartum low milk consumption, accurate compliance, and proper supply. If the milk volume did not meet the expressing of the milk were under supervision infant's daily oral feeding requirements and the of 2 trained nurses. Compliance was monitored stained light urine diapers were less than 4-6 by capsule count as well. No support in numbers a day in these exclusively breastfed breastfeeding technique was provided. infants, the mothers were considered as low During drug administrating from day three of milk supply. postpartum for seven days , the breast milk was The lactation consultants’ team assessed expressed daily at the same pre-test procedure, these mothers; they were given instructions every three hours (average of 6 times a day) by on methods for augmenting milk supply mechanical breast milk pump, and the quantity and counselled
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