Nashreen C M, Hamdan Mukhri, Hong Jesrine, Kamarudin Maherah, Saaid Rahmah, Tan Peng Chiong
Department of Obstetrics and Gynecology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Acta Obstet Gynecol Scand. 2024 Dec;103(12):2475-2484. doi: 10.1111/aogs.14975. Epub 2024 Oct 2.
Our objective was to compare the performance of the first vaginal examination at 8 vs 4 h after amniotomy following Foley ripening in nulliparous labor induction.
A randomized controlled trial was conducted from June 2021 to January 2022. 210 nulliparas at term for labor induction were randomized: 105 each to first vaginal examination at 8 or 4 h after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to expedite labor. Primary outcomes were the amniotomy-to-delivery interval (non-inferiority hypothesis) and maternal satisfaction with their allocated labor care (superiority hypothesis) within 24 h after delivery. Analyses performed using t-test, Mann-Whitney U test, and Chi-squared test as appropriate.
The amniotomy-to-delivery interval was mean ± standard deviation 8.7 ± 3.4 vs 8.4 ± 3.7, mean difference 0.4 (97.5% CI: -0.7 to 1.5) hours, p = 0.442 within the pre-specified 2-hour non-inferiority margin, and maternal satisfaction score with allocated labor care was median [interquartile range] 8[7.5-10] vs 8[7.0-10], p = 0.248 for 8 vs 4 h arms, respectively. The amniotomy to first vaginal examination intervals was 5.9 ± 2.3 vs 3.6 ± 1.0 h, p < 0.001, and the number of vaginal examinations was 2[1-2.5] vs 3 [2, 3], p < 0.001 for 8 vs 4 h, respectively. The first vaginal examination was less likely to have been performed as scheduled, more likely to be indicated by the urge to bear down, and non-reassuring cardiotocography for the 8 h arm (p < 0.001). Spontaneous vaginal delivery was significantly more likely and instrumental vaginal delivery less likely, but cesarean rate was not significantly different for the 8 h arm (p = 0.017).
A routine first vaginal examination at 8 h compared to 4 h is non-inferior for the time to birth but does not increase maternal satisfaction although the number of vaginal examinations is fewer. The increase in spontaneous vaginal delivery and reduction in instrumental vaginal delivery rates warrant further powered primary evaluation.
我们的目的是比较初产妇引产在使用福莱氏球囊促宫颈成熟并破膜后8小时与4小时进行首次阴道检查的效果。
于2021年6月至2022年1月进行了一项随机对照试验。210名足月引产的初产妇被随机分组：每组105人，分别在福莱氏球囊促宫颈成熟并破膜后8小时或4小时进行首次阴道检查。破膜后常规开始滴注缩宫素以加速产程。主要结局指标为破膜至分娩间隔时间（非劣效性假设）以及产后24小时内产妇对其分配到的分娩护理的满意度（优效性假设）。根据情况使用t检验、曼-惠特尼U检验和卡方检验进行分析。
破膜至分娩间隔时间的均值±标准差分别为8.7±3.4小时和8.4±3.7小时，平均差值为0.4（97.5%可信区间：-0.7至1.5）小时，在预先设定的2小时非劣效性界限内，p = 0.442；8小时组和4小时组产妇对分配到的分娩护理的满意度评分中位数[四分位间距]分别为8[7.5 - 10]和8[7.0 - 10]，p = 0.248。破膜至首次阴道检查的间隔时间分别为5.9±2.3小时和3.6±1.0小时，p < 0.001；8小时组和4小时组的阴道检查次数分别为2[1 - 2.5]次和3[2, 3]次，p < 0.001。8小时组首次阴道检查更不太可能按计划进行，更有可能因有向下用力的冲动以及胎心监护结果不令人放心而进行（p < 0.001）。8小时组自然阴道分娩的可能性显著更高，器械助产阴道分娩的可能性更低，但剖宫产率无显著差异（p = 0.017）。
与4小时相比，8小时进行常规首次阴道检查在分娩时间方面非劣效，但尽管阴道检查次数较少，却并未提高产妇满意度。自然阴道分娩率的增加和器械助产阴道分娩率的降低值得进行更有说服力的初步评估。
