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| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
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Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries.
Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.
The study aims to determine the breastfeeding initiation and duration rate of a cohort of pregnant women with gestational diabetes(diet-controlled) and insulin dependent and pre-existing diabetes, assess the impact of a post natally administered galactogogue, metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women on diet control and insulin and determine the prolactin response to lactation among diabetic women on diet control and insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a | Active Comparator | Mother with diet-controlled diabetes receive Metoclopramide 10 mg 3 times a day for the first 7 days, and 2 times a day for day 8 to 10, and once a day from day 11 to day 12 |
|
| b | Placebo Comparator | Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day for day 11 to 12 |
|
| c | Active Comparator | Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, and once a day from day 11 to 12 |
|
| d | Placebo Comparator | Placebo 10 mg 3 times a day for 7 days, 2 times a day for day 8 to 10; and once a day from day 11 to 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide (Maxolon) | Drug | Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II | within the first two weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| amount of breastmilk determined by testweighing and expressed milk volumes, weight change on day 7 and breastfeeding status up to 6 months | within 6 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chong Y S, MBBS,MRACOG | National University Hospital and National University of Singapore | Principal Investigator |
| Citra Mattar, MBBS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12225305 | Background | Cregan MD, De Mello TR, Kershaw D, McDougall K, Hartmann PE. Initiation of lactation in women after preterm delivery. Acta Obstet Gynecol Scand. 2002 Sep;81(9):870-7. doi: 10.1034/j.1600-0412.2002.810913.x. | |
| 11795051 | Background | Hartmann PE, Cregan MD, Mitoulas LR. Maternal modulation of specific and non-specific immune components of colostrum and mature milk. Adv Nutr Res. 2001;10:365-87. doi: 10.1007/978-1-4615-0661-4_18. No abstract available. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Placebo | Drug | Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12 |
|
| 11694639 | Background | Hartmann P, Cregan M. Lactogenesis and the effects of insulin-dependent diabetes mellitus and prematurity. J Nutr. 2001 Nov;131(11):3016S-20S. doi: 10.1093/jn/131.11.3016S. |
| 15684169 | Background | Hansen WF, McAndrew S, Harris K, Zimmerman MB. Metoclopramide effect on breastfeeding the preterm infant: a randomized trial. Obstet Gynecol. 2005 Feb;105(2):383-9. doi: 10.1097/01.AOG.0000151113.33698.a8. |
| 32421208 | Derived | Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2. |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |