Department of Obstetrics and Gynaecology, Delta State University Teaching Hospital, Otefe, Oghara, Delta State, Nigeria.
Niger J Clin Pract. 2023 Jul;26(7):871-880. doi: 10.4103/njcp.njcp_251_22.
Cervical ripening is one of the most important determinants of the outcome of induction of labor. The findings of studies on the most efficacious inflatable catheter balloon volume for pre-induction cervical ripening have been inconclusive.
To compare the efficacy of the use of different intracervical Foley catheter balloon volumes (30-, 50-, and 60-mL) on cervical ripening.
This study was a triple-blind randomized controlled trial. Two hundred and sixteen women with a Bishop score ≤5 at term were randomly assigned into three groups (1:1:1) to receive an intracervical single size eighteen Foley balloon catheter inflated either with 30-mL (control arm) or 50-mL and 60-mL (intervention arm) of sterile saline which was retained for a duration of 12 h. The primary outcome measures were the mean change in Bishop score and achieving a Bishop score of ≥6 at the twelfth-hour post-Foley catheter balloon insertion.
In the total study population and among nulliparous women, the 50-mL and 60-mL balloons compared with the 30-mL Foley catheter balloon achieved a statistically significantly greater mean change in Bishop scores at the twelfth hour\post-insertion (P = 0.005 and P = 0.001), while the 60-mL balloon compared with the 30-mL and 50-mL balloons achieved statistically significant higher mean change in Bishop scores among multiparous women (P = 0.047 and P = 0.003) and cervical dilatation irrespective of parity (P = 0.003 and P = 0.002), at the twelfth-hour post-insertion. The larger catheter balloons were also associated with a statistically significant greater chance of having an induction to delivery interval of <12 h in nulliparous women P = 0.003.
The findings of this study showed that the larger single Foley catheter balloon volumes (50-mL and 60-mL) aside from being well tolerated and acceptable have the ability to induce faster changes in Bishop score, produce higher cervical dilation, and thus likely reduce significantly the total labor induction process compared to the 30-mL single catheter balloon volume irrespective of parity.
宫颈成熟度是影响引产结局的最重要决定因素之一。关于最有效的充气式导管球囊用于引产前宫颈成熟度的研究结果尚无定论。
比较不同宫腔内 Foley 导管球囊体积（30ml、50ml 和 60ml）用于宫颈成熟的效果。
本研究为三盲随机对照试验。216 名足月且 Bishop 评分≤5 的妇女被随机分为三组（1:1:1），分别接受宫腔内单个 18Fr Foley 导管球囊，分别注入 30ml（对照组）、50ml 和 60ml（干预组）无菌生理盐水，保留 12 小时。主要结局指标为 Bishop 评分的平均变化和 Foley 导管球囊插入后 12 小时达到≥6 的 Bishop 评分。
在总研究人群和初产妇中，与 30ml Foley 导管球囊相比，50ml 和 60ml 球囊在 Foley 导管球囊插入后 12 小时的 Bishop 评分平均变化更大（P=0.005 和 P=0.001），而与 30ml 和 50ml 球囊相比，60ml 球囊在经产妇中 Bishop 评分的平均变化更大（P=0.047 和 P=0.003）和宫颈扩张（无论经产与否）（P=0.003 和 P=0.002），在 Foley 导管球囊插入后 12 小时。较大的导管球囊还与初产妇的诱导分娩间隔<12 小时的可能性显著增加相关（P=0.003）。
本研究结果表明，较大的单个 Foley 导管球囊体积（50ml 和 60ml）除了耐受性好、可接受外，还具有更快地改变 Bishop 评分的能力，产生更高的宫颈扩张度，从而可能显著缩短与 30ml 单导管球囊体积相比的总分娩诱导过程，无论产次如何。
