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.

摘要 在美国，每年有超过100万妇女接受引产， 是最常用的方法。然而，与自然分娩相比，药物引产是资源- 密集的，增加了产科风险，并与不太成功的母乳喂养。相比 合成催产素是大脑中以脉动方式释放的内源性催产素激素， 持续静脉内输注，导致与功效、安全性和成本相关的重要限制。 类似于自发性分娩收缩，婴儿吮吸乳头会刺激搏动性 从垂体后叶释放内源性催产素。乳头电刺激疗法 吸奶器同样刺激内源性催产素的释放，我们的初步工作表明，它是一种 可行且可接受的住院方法，可为未产妇带来理想的子宫收缩模式。 我们对100名随机初产妇的初步研究表明，分娩期乳头刺激疗法 产程持续时间和阴道自然分娩率显著增加的趋势， 合成催产素注射液此外，乳头刺激减少了合成催产素的剂量和持续时间 即使使用了合成催产素。因此，乳头刺激疗法可能会被证明， 是一种有效的引产方法，可增加自然阴道分娩的可能性，以及 还具有额外的生理益处。例如，乳头刺激通过诱导乳汁分泌来触发泌乳 我们的初步工作还表明，通过电动吸奶器刺激乳头治疗， 导致大多数妇女，包括第一次做母亲的妇女，过早产生初乳和乳汁减少。 早期哺乳可以减轻最常见的原因，早期母乳喂养中断， 改善母亲对母乳供应不足和婴儿体重减轻严重程度的感觉 在生命的最初几天，当他们建立喂养。这反过来又会提高持续的可能性。 母乳喂养的建议6个月，这也有许多短期和长期的好处。 因此，在分娩过程中进行乳头刺激疗法具有巨大的潜在公共卫生和成本 在贫穷地区，包括在发展中国家，其成功将特别重要。 我们建议在耶鲁大学和西北大学进行一项多中心随机试验， 通过电动吸奶器进行乳头刺激治疗与立即注射合成催产素相比， 对接受引产的初产妇进行乳头刺激。这项对988名未经产妇女的试验将 提供足够的统计学显著性，以检测输送模式中有临床意义的差异， 母乳是新生儿唯一的营养来源。成功完成此提案将提供 严格的数据，以帮助我们展示这种新颖的和潜在的成本效益的方法可以从根本上改变 我们如何诱导分娩，并通过哺乳对母乳喂养成功和早期婴儿营养产生积极影响。