Institut für Sozialmedizin, Epidemiologie und Gesundheitssystemforschung e. V.Bereich Outcome- und Evaluationsforschung, Lavesstrasse 80, Hannover, Germany.
Dtsch Arztebl Int. 2011 Feb;108(6):81-6. doi: 10.3238/arztebl.2011.0081. Epub 2011 Feb 11.
From 2004 to 2006, in a model project carried out by four German health insurers, expectant mothers were offered self-testing of vaginal pH in order to prevent preterm delivery. They were given pH test gloves on request so that they could measure their vaginal pH twice a week from the 12(th) to the 32(nd) week of gestation. They were instructed to consult with a gynecologist after any positive result. All further diagnostic or therapeutic decisions were at the discretion of the treating gynecologist. We assessed the effectiveness of the screening intervention, using delivery before the 37th week of gestation as the primary endpoint.
In this prospective, controlled trial, we collected data on deliveries from 2004 to 2006 that were covered by the four participating insurers in five German federal states. We compared the outcomes of pregnancy in women who did and did not request test gloves (intervention group, [IG], and control group, [CG]). The data were derived from claims data of the participating insurers, as well as from a nationwide quality assurance auditing program for obstetrics and perinatal care. Propensity score matching and multivariate adjustment were used to control for the expected self-selection bias.
The study sample comprised 149 082 deliveries. 13% of the expectant mothers requested test gloves, about half of them up to the 16(th) week of gestation. As expected, women with an elevated risk of preterm birth requested test gloves more often. Delivery before the 37(th) week of gestation was slightly more common in the intervention group than in the control group (IG 7.97%, CG 7.52%, relative risk 1.06, 95% confidence interval 1.00-1.12). This result was of borderline statistical significance in the propensity score matched analysis, but it was not statistically significant in the multivariate model.
This trial did not demonstrate the efficacy of self-testing of vaginal pH for the prevention of preterm delivery (< 37 weeks of gestation).
2004 年至 2006 年，在德国四家健康保险公司开展的一项示范项目中，孕妇可自行进行阴道 pH 值检测，以预防早产。应孕妇要求，为其提供 pH 值检测手套，以便她们在妊娠第 12 周至第 32 周期间每周自行检测两次阴道 pH 值。如果检测结果为阳性，孕妇需咨询妇产科医生。所有进一步的诊断或治疗决策由主治妇产科医生自行决定。我们以妊娠不满 37 周的分娩作为主要终点，评估了该筛查干预的有效性。
在这项前瞻性、对照试验中，我们收集了 2004 年至 2006 年期间，五个德国联邦州的四家参与保险公司承保的分娩数据。我们比较了使用和未使用检测手套的孕妇（干预组[IG]和对照组[CG]）的妊娠结局。数据来自参与保险公司的索赔数据，以及全国性的妇产科和围产期保健质量保证审计计划。采用倾向评分匹配和多变量调整来控制预期的自我选择偏倚。
研究样本包括 149082 例分娩。13%的孕妇要求使用检测手套，其中约一半人在妊娠第 16 周前提出要求。正如预期的那样，有早产风险的孕妇更频繁地要求使用检测手套。与对照组相比，干预组的妊娠不满 37 周的分娩率略高（IG7.97%，CG7.52%，相对风险 1.06，95%置信区间 1.00-1.12）。在倾向评分匹配分析中，该结果具有边缘统计学意义，但在多变量模型中无统计学意义。
这项试验未能证明阴道 pH 值自我检测预防早产（<37 周妊娠）的有效性。
