刺激疗法诱导母亲:多中心随机对照试验的协议
Danna Tortal1, Veronika Shabanova1, Sarah Taylor1
1Yale School of Medicine, New Haven, CT, United States.
JMIR research protocols
|August 29, 2024
概括
与合成催产素相比,乳头刺激疗法可能提供一种更有效,更自然的劳动诱导方法,可能改善自发性阴道分娩和母乳养成功.
科学领域:
- 产科和妇科 产科和妇科
- 生殖医学 生殖医学
- 新生儿营养新生儿营养
背景情况:
- 合成催产素输液是引产的标准,但资源密集,并与增加的风险和较差的母乳养结果有关.
- 内源性催产素以脉动方式释放,与持续合成输液不同,在有效性和安全性方面存在局限性.
- 乳头刺激,模仿自然劳动,刺激内源性催产素的释放,这表明一个潜在的有利的住院患者的诱导方法.
研究的目的:
- 评估住院患者的乳头刺激疗法作为一种有效的劳动诱导方法.
- 为了确定乳头刺激是否会增加自发性阴道分娩和持续哺乳率.
- 评估乳头刺激疗法的成本效益,以诱导分娩.
主要方法:
- 一个多中心,随机对照试验,涉及988名无产期患者,在怀孕≥36周接受分娩诱导.
- 使用电动乳房和标准合成催产素输液的住院乳头刺激疗法之间的比较.
- 主要结局包括分娩方式和在医院出院时或产后72小时的纯母乳养.
主要成果:
- 在2021年获得试点资金,在2023年获得全额资金.
- 招生于2021年11月开始,截至2024年5月,招聘正在3个地点进行.
- 预计在2026年底之前完成招生.
结论:
- 这项试验旨在提供关于乳头刺激疗法的有效性,劳动诱导的强有力的数据.
- 结果可能表明改善了劳动诱导方法和提高了母乳养成功和婴儿营养.
- 这项研究将为临床实践提供有关替代劳动诱导策略的信息.
更多相关视频
相关概念视频
00:55Parental Care
Many animals exhibit parental care behavior, including feeding, grooming, and protecting young offspring. Parental care is universal in mammals and birds, which often have young that are born relatively helpless. Several species of insects and fish, as well as some amphibians, also care for their young.
01:13Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.