STIM: Stimulation Therapy to induce Mothers: a Multicenter Trial

STIM：诱导母亲的刺激疗法：多中心试验

• 批准号: 10639362
• 负责人: Moeun Son
• 金额: $ 65.4万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10639362
• 关键词: Area; Birth; Body Weight decreased; Brain; Breast; Breast Feeding; Childbirth; Clinical; Colostrum; Conduct Clinical Trials; Continuous Infusion; Continuous Intravenous Infusion; Cost Analysis; Costs and Benefits; Data; Developing Countries; Devices; Discipline of obstetrics; Dose; Down-Regulation; Frequencies; Health Benefit; Health Care Costs; Hormones; Hospitals; Human Milk; Hydration status; Induced Labor; Infant; Infant Care; Infant Health; Infusion procedures; Inpatients; Intervention; Intravenous infusion procedures; Investigation; Lactation; Life; Maternal Health; Medical; Methods; Milk Ejection; Molecular; Mothers; Multicenter Trials; Muscle; Myometrial; National Institute of Child Health and Human Development; Newborn Infant; Nipples; Nulliparity; Outcome; Oxytocin; Oxytocin Receptor; Patient Participation; Perception; Physiological; Pilot Projects; Posterior Pituitary Gland; Postpartum Period; Poverty; Poverty Areas; Production; Public Health; Publishing; Randomized; Recommendation; Reflex action; Resources; Risk; Safety; Severities; Source; Testing; Time; United States; Universities; Uterine Contraction; Vaginal delivery procedure; Woman; Work; acceptability and feasibility; blood-brain barrier penetration; breast pump; care costs; comparison group; cost; cost effective; cost effectiveness; experience; feeding; health related quality of life; improved; infant nutrition; intrapartum; lactogenesis; milk expression; milk supply; novel; nutrition; obstetrical complication; pregnant; premature; randomized trial; randomized, clinical trials; success; suckling; therapeutically effective; trend

ABSTRACT Over 1 million women have their labor induced in the United States each year, and synthetic oxytocin infusion is the most common method used. However, compared to spontaneous labor, medical induction is resource- intensive, has increased obstetric risks, and is associated with less successful breastfeeding. In contrast to endogenous oxytocin hormone which is released in a pulsatile fashion in the brain, synthetic oxytocin is continuously infused intravenously, resulting in important limitations related to efficacy, safety, and cost. Akin to spontaneous labor contractions, infant suckling of the breast nipple is known to stimulate the pulsatile release of endogenous oxytocin from the posterior pituitary gland. Nipple stimulation therapy via electric breast pump similarly stimulates endogenous oxytocin release, and our preliminary work shows that it is a feasible and acceptable inpatient method that results in a desirable uterine contraction patter n in nulliparas. Our pilot study of 100 randomized nulliparas showed that intrapartum nipple stimulation therapy decreases labor duration and trends toward a significant increase in the rate of spontaneous vaginal delivery compared to synthetic oxytocin infusion. Further, nipple stimulation reduced the dose and duration of synthetic oxytocin even when adjunctive synthetic oxytocin was used. Therefore, nipple stimulation therapy will likely prove to be an efficacious labor induction method that increases the likelihood of spontaneous vaginal delivery, and also have added physiologic benefits. For example, nipple stimulation triggers lactation by inducing the milk ejection reflex, and our preliminary work also shows that nipple stimulation therapy via electric breast pump results in early colostrum production and milk letdown in the majority of women, including first-time mothers. Earlier lactation would alleviate the most common reasons for early breastfeeding discontinuation by improving maternal perception of insufficient milk supply and the severity of weight loss that occurs in infants in the first few days of life as they establish feeding. This in turn would improve the likelihood of sustained breastfeeding for the recommended 6 months, which also has many short- and long-term benefits. Consequently, nipple stimulation therapy during labor has tremendous potential public health and cost benefits, and its success would be particularly important in areas of poverty, including developing countries. We propose a multicenter randomized trial at Yale and Northwestern Universities to compare inpatient nipple stimulation therapy via electric breast pump versus immediate synthetic oxytocin infusion without nipple stimulation for nulliparous women undergoing labor induction. This trial of 988 nulliparous women will provide adequate statistical significance to detect clinically meaningful differences in delivery mode and breastmilk as the sole source of nutrition for newborns. Successful completion of this proposal will provide rigorous data to help us show how this novel and potentially cost-effective method can radically change the way we induce labor and positively impact breastfeeding success and early infant nutrition through lactation.

抽象的 每年在美国诱发了超过100万妇女的劳动，并输注合成催产素 是最常见的方法。但是，与自发的劳动相比，医学归纳是资源 - 密集型，增加了产科风险，并且与不太成功的母乳喂养有关。与 内源性催产素激素以巨大的搏动方式释放，合成催产素是 不断静脉注入，从而产生了与功效，安全性和成本有关的重要限制。 类似于自发的劳动收缩，众所周知，婴儿哺乳是刺激脉动的 垂体后腺内源性催产素的释放。通过电动乳头刺激疗法 吸奶泵类似地刺激内源性催产素释放，我们的初步工作表明它是一个 可行且可接受的住院方法，导致零质体中理想的子宫收缩模式N。 我们对100个随机零下的试点研究表明，乳头内乳头刺激疗法降低 劳动持续时间和趋势朝着自发性阴道递送率显着增加 进行合成催产素输注。此外，乳头刺激降低了合成催产素的剂量和持续时间 即使使用辅助合成催产素。因此，乳头刺激疗法可能会证明 成为一种有效的劳动诱导方法，可增加自发的阴道传递的可能性，并 还增加了生理上的好处。例如，乳头刺激通过诱导牛奶诱导泌乳 射血反射，我们的初步工作还表明通过电动泵的乳头刺激疗法 导致大多数妇女（包括首次母亲）的早期初乳和牛奶失败。 较早的泌乳将减轻早期母乳喂养中断的最常见原因 提高产妇对牛奶供应不足的看法和婴儿的体重减轻严重程度 在生命的头几天，他们建立喂养。反过来，这将提高持续的可能性 推荐6个月的母乳喂养，这也有许多短期和长期福利。 因此，劳动期间乳头刺激疗法具有巨大的潜在公共卫生和成本 利益及其成功在包括发展中国家在内的贫困地区尤其重要。 我们建议在耶鲁大学和西北大学进行多中心随机试验，以比较住院 通过电动泵与立即合成催产素输注的乳头刺激疗法无需 对劳动诱导的无效妇女的乳头刺激。 988个无效妇女的审判将 提供足够的统计显着性，以检测临床有意义的分娩模式差异和 母乳是新生儿营养的唯一来源。该提案的成功完成将提供 严格的数据以帮助我们展示这种小说和潜在的具有成本效益的方法如何从根本上改变 我们通过泌乳诱导劳动并积极影响母乳喂养的成功和早期婴儿营养。