Kempe A, Sachs B P, Ricciotti H, Sobol A M, Wise P H
Department of Pediatrics, Harvard Medical School, Boston, USA.
Public Health Rep. 1997 Sep-Oct;112(5):433-9.
Despite controversy regarding the efficacy of home uterine activity monitoring (HUAM), it is currently licensed for detection of preterm labor in women with previous preterm deliveries. In practice, however, it is being more widely utilized in an effort to prevent preterm delivery. This study seeks to determine which group of mothers delivering very low birth weight (VLBW) infants would have qualified for HUAM given three different sets of criteria and in which women it could have been used to help prolong gestation.
The authors reviewed the medical records of mothers of VLBW infants born in five U.S. locations (N = 1440), retrospectively applying three sets of eligibility criteria for HUAM use: (a) the current FDA licensing criterion for use of HUAM, a previous preterm birth; (b) indication for HUAM commonly cited in published reports; (c) a broad set of criteria based on the presence of any reproductive or medical conditions that might predispose to premature delivery. The authors then analyzed the conditions precipitating delivery for each group to determine whether delivery might have been prevented with HUAM and tocolytic therapy.
Only 4.4% of the total group of women delivering VLBW infants would have been eligible for HUAM under the FDA criterion and might potentially have benefited from this technology. If extremely broad criteria had been applied to identify those eligible for monitoring, under which almost 80% of all women who delivered VLBW infants would have been monitored, only 20.3% of the total group would have been found eligible and would potentially have benefited. If such broad criteria were applied to all pregnant women, a sizable proportion of pregnancies would be monitored at great expense with small potential clinical benefit.
Because VLBW births are usually precipitated by conditions that are unlikely to benefit from HUAM, this technology will have little impact on reducing VLBW and neonatal mortality rates. More comprehensive preventive strategies should be sought.
尽管家庭子宫活动监测(HUAM)的疗效存在争议,但目前它已被批准用于检测有早产史的女性的早产情况。然而在实际应用中,它正被更广泛地用于预防早产。本研究旨在确定在三种不同的标准下,哪些分娩极低出生体重(VLBW)婴儿的母亲符合HUAM的条件,以及在哪些女性中它可以用于帮助延长孕周。
作者回顾了在美国五个地点出生的VLBW婴儿母亲的病历(N = 1440),回顾性地应用了三组HUAM使用的资格标准:(a)HUAM当前的FDA许可标准,即有早产史;(b)已发表报告中普遍引用的HUAM指征;(c)基于任何可能易导致早产的生殖或医疗状况的广泛标准。然后作者分析了每组导致分娩的情况,以确定使用HUAM和宫缩抑制剂治疗是否可能预防分娩。
根据FDA标准,在分娩VLBW婴儿的女性总群体中,只有4.4%符合HUAM的条件,并且可能从该技术中受益。如果应用极其宽泛的标准来确定那些符合监测条件的人,在几乎80%分娩VLBW婴儿的女性都会接受监测的情况下,在总群体中只有20.3%会被发现符合条件并可能受益。如果将这样宽泛的标准应用于所有孕妇,将有相当比例的妊娠会被监测,费用高昂但潜在临床益处很小。
由于VLBW出生通常是由不太可能从HUAM中受益的情况所导致,这项技术对降低VLBW和新生儿死亡率几乎没有影响。应寻求更全面的预防策略。