Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- successful initiation of lactation as determined by lactogenesis II markers
研究概览
简要总结
Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.
The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.
详细描述
Hypothesis
Early Use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.
Metoclopramide(Maxolon) promotes lactation by antagonizing the release of dopamine in the central nervous system, thereby increasing prolactin levels, and thus inducing or augmenting breast milk levels. While Metoclopramide has commonly been used to augment breast milk production and relactation, its efficacy in helping to establish lactogenesis II has never been studied in a controlled clinical trial. If effective, it may become a valuable tool in aiding the successful establishment of breastfeeding, particularly in high risk groups such as mothers of preterm babies.
If shown to be an effective galactogogue, the use of metoclopramide provides an inexpensive and safe means of establishing and sustaining lactogenesis II, indirectly improving the degree and duration of breastfeeding practiced by mothers of both term and preterm infants.
The anticipated benefits are expected to be greatest for preterm infants and their mothers.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women who intend to breastfeed, from 28 weeks to term, who have not met the exclusion criteria
排除标准
- •Patients 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
- •Patients who have a known allergy or prior reaction to metoclopramide, or any other contraindications to the use of metoclopramide
- •Patients who have diabetes and hyperprolactinaemia
- •Patients with HIV infection
- •Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
研究组 & 干预措施
A
Mothers with pre-term deliveries will receive metoclopramide 10 mg three times a day for the first 7 days and 2 times a day for the 8th to 10th day, and once a day for the 11th to 12th day
干预措施: Metoclopramide (Maxolon) (Drug)
B
Mothers with pre-term deliveries will receive metoclopramide 10 mg 3 times a day, 2 times a day from 8th to 10th day and once a day from 11th to 12th day
干预措施: placebo (Drug)
C
Mothers with full term deliveries will receive 10 mg metoclopramide, 3 times a day for the first 7 days, 2 times a day from 8th to 10th day, and once a day for day 11 to 12
干预措施: Metoclopramide (Maxolon) (Drug)
D
Mothers with full term deliveries will receive the placebo 10 mg three times a day, for 7 days, and two times a day from day 8 to day 10, and once a day from 11th to 12th day
干预措施: placebo (Drug)
结局指标
主要结局
successful initiation of lactation as determined by lactogenesis II markers
时间窗: 7 days postpartum
次要结局
- weight change in baby 7 days after birth(14 days postpartum)
- breastfeeding status at 14 days, 6 weeks, 3 months and 6 months after delivery(6 months postpartum)