Somirathne D, Goonewardene Malik, Dasanayake L
Teaching Hospital Mahamodara, Galle, Sri Lanka
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Ruhuna, Sri Lanka.
Ceylon Med J. 2017 Jun 30;62(2):77-82. doi: 10.4038/cmj.v62i2.8470.
To compare three doses of oral misoprostol 50μg four hourly versus an intra-cervical Foley catheter for 24 hours, for pre-induction cervical ripening.
Primary investigator blinded, randomised controlled trial conducted in 180 consecutive women with singleton uncomplicated pregnancies with Modified Bishop Score (MBS) 5 at 40 weeks + 6 days gestation, allocated by stratified (primigravida / multigravida) block randomization to receive three doses of oral misoprostol 50μg four hourly or an intra-cervical Foley catheter for 24 hours. MBS reassessed at 41 weeks gestation. If MBS 7, induction of labour (IOL) with amniotomy and intravenous oxytocin infusion. If MBS<7, cross over therapy with intracervical Foley catheter for misoprostol group, vaginal prostaglandin E2 for Foley group.
At commencement, no significant differences in age, parity, body mass index and MBS between the two groups. Greater proportions established labour in both primigravidae (30% vs. 9%; RR=4.4, 95% CI 1.3-14.6; p=0.01) and multigravidae (44%.vs.16%; RR=4.3; 95% CI 1.6-11.8; p=0.003) before 41 weeks of gestation in misoprostol group compared to the Foley group. Among the multigravidae, the mean increase of MBS was greater in the misoprostol group (3.1; 95% CI 2.4-4) compared to the Foley group (2.4; 95% CI 1.9-2.7, p=0.04). One primigravida and two multigravidae developed hyper stimulation after misoprostol therapy. No significant differences in the other maternal and perinatal outcomes.
Compared to an intra-cervical Foley catheter for 24 hours, three doses of oral misoprostol 50μg four hourly was more effective for cervical ripening and even resulted in IOL.
比较每四小时口服50μg米索前列醇的三种剂量与宫颈内放置Foley导管24小时用于引产术前宫颈成熟的效果。
主要研究者设盲的随机对照试验，纳入180例单胎、无并发症妊娠且妊娠40周+6天时改良Bishop评分（MBS）≤5的连续孕妇，通过分层（初产妇/经产妇）区组随机化分组，分别接受每四小时口服50μg米索前列醇的三种剂量或宫颈内放置Foley导管24小时。在妊娠41周时重新评估MBS。如果MBS≥7，则行人工破膜及静脉滴注缩宫素引产。如果MBS<7，米索前列醇组采用宫颈内放置Foley导管进行交叉治疗，Foley导管组采用阴道前列腺素E2治疗。
开始时，两组在年龄、产次、体重指数和MBS方面无显著差异。与Foley导管组相比，米索前列醇组在妊娠41周前初产妇（30%对9%；RR=4.4，95%CI 1.3 - 14.6；p=0.01）和经产妇（44%对16%；RR=4.3；95%CI 1.6 - 11.8；p=0.003）中成功引产的比例更高。在经产妇中，米索前列醇组MBS的平均增加值（3.1；95%CI 2.4 - 4）高于Foley导管组（2.4；95%CI 1.9 - 2.7，p=0.04）。1例初产妇和2例经产妇在米索前列醇治疗后出现子宫过度刺激。其他母婴结局无显著差异。
与宫颈内放置Foley导管24小时相比，每四小时口服50μg米索前列醇的三种剂量在宫颈成熟方面更有效，甚至可导致引产。
