STIM: Stimulation Therapy to induce Mothers: a Multicenter Trial

摘要 美国每年有100多万妇女引产，并注射合成催产素 是最常用的方法。然而，与自然分娩相比，医疗诱导是一种资源- 高强度的母乳喂养增加了产科风险，并与母乳喂养不太成功有关。与之形成鲜明对比的是 在大脑中以脉动方式释放的内源性催产素，合成的催产素是 持续静脉输注，导致与疗效、安全性和成本相关的重要限制。 类似于自发的分娩收缩，婴儿吮吸乳房乳头被认为可以刺激搏动 从脑下垂体后叶释放内源性催产素。乳头电刺激疗法 吸奶器类似地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治疗方法，可使未产妇获得理想的宫缩模式。 我们对100名未产妇的初步研究表明，产中乳头刺激疗法减少了 比较产程和自然阴道分娩率显著增加的趋势 到合成催产素输液。此外，乳头刺激减少了合成催产素的剂量和持续时间 即使在使用辅助合成催产素的情况下。因此，乳头刺激疗法可能会被证明 是一种有效的引产方法，可以增加自然阴道分娩的可能性，以及 也有额外的生理益处。例如，乳头刺激通过诱导乳汁来触发哺乳。 射血反射，我们的初步工作还表明，通过电动吸乳器进行乳头刺激治疗 导致大多数妇女，包括第一次母亲的早期初乳产生和乳汁排出。 提早哺乳可以减少最常见的提早停止母乳喂养的原因 改善母亲对母乳供应不足和婴儿体重下降严重程度的看法 在生命的最初几天，当它们开始进食时。这反过来又会提高持续的 母乳喂养的建议为6个月，这也有许多短期和长期的好处。 因此，产程中乳头刺激疗法具有巨大的公共卫生潜力和成本。 它的成功将在包括发展中国家在内的贫困地区尤为重要。 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来比较住院患者 电动吸乳器乳头刺激疗法与不立即输注合成催产素的比较 未产妇引产时的乳头刺激。这项对988名未分娩妇女的审判将 提供足够的统计意义以检测分娩方式和分娩方式的临床意义差异 母乳是新生儿唯一的营养来源。成功完成这项提案将提供 严谨的数据帮助我们展示这种新的和潜在的成本效益方法如何从根本上改变 引产方式通过哺乳对母乳喂养成功率和婴儿早期营养产生积极影响。

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.