Metoclopramide to Improve Lactogenesis II in Diabetic Women: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women with pregestational or gestational diabetes under diet or insulin control
排除标准
- •Patient who have epilepsy or on anti-seizure medications,
- •Patients who have a history of significant depression or are on antidepressant drugs
- •Patients who have pheochromocytoma or uncontrolled hypertension
- •Patients who have intestinal bleeding or obstruction
- •Patient with known allergy or prior reaction to metoclopramide
- •Patient with HIV infection
- •Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
研究组 & 干预措施
a
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
干预措施: Metoclopramide (Maxolon) (Drug)
b
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
干预措施: Placebo (Drug)
c
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
干预措施: Metoclopramide (Maxolon) (Drug)
d
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
干预措施: Placebo (Drug)
结局指标
主要结局
a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II
时间窗: within the first two weeks postpartum
次要结局
- 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)