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口服米索前列醇 48 小时与宫颈高位 Foley 导管 48 小时用于过期妊娠引产:一项随机对照试验。

Oral Misoprostol for 48 hours Versus a Supra Cervical Foley Catheter for 48 Hours for Induction of Labour in Post Dated Pregnancies: A Randomized Control Trial.

机构信息

Academic Obstetrics and Gynaecology Unit, Teaching Hospital Mahamodara, Galle, Sri Lanka,

出版信息

Ceylon Med J. 2021 Jun 30;66(2):77-86. doi: 10.4038/cmj.v66i2.9468.

DOI:10.4038/cmj.v66i2.9468
PMID:35569002
Abstract

AIMS

To assess the feasibility of administration of three doses of oral misoprostol (OM) 50 µg four hourly per day for 48 hours versus the insertion of a supra cervical Foley catheter for 48 hours, in women at 40 weeks + 5 days gestation, and compare the effectiveness of the two methods for induction of labour (IOL).

METHOD

An investigator blinded, randomized controlled trial was conducted at the academic obstetric unit, Teaching Hospital Mahamodara, Galle from 13.10.2016 to 30.04.2017. Consecutive women (n=144) with singleton uncomplicated pregnancies having Modified Bishop Score (MBS) <5 at 40weeks + 5days gestation were allocated by stratified (primigravidae/ multigravidae) block randomization to receive three doses of OM 50µg four hourly per day for 48 hours or a supra cervical Foley catheter for 48 hours.

RESULTS

Compared to the Foley, OM resulted in higher rates of successful IOL (67% vs 47%, RR 1.4, 95% CI 1.1 - 2.0, p =0.029), more vaginal deliveries within 24 hours and 48 hours, shorter mean induction delivery intervals and greater mean increase in MBS in those not in labour after 48 hours. There was non-significant increased frequency of excessive uterine activity, cardiotocograph abnormalities and meconium stained liquor after OM but no differences in the rates of caesarean deliveries and maternal or neonatal morbidity or mortality between the two groups.

CONCLUSION

The administration of three doses oral misoprostol (OM) 50 µg four hourly per day for 48 hours as well as the insertion of a supra cervical Foley catheter for 48 hours were feasible for women at 40 weeks + 5 days gestation, but OM was more effective than the Foley catheter for IOL.

摘要

目的

评估在 40 周+5 天妊娠的妇女中,每天 4 小时口服米索前列醇(OM)50μg,每天 3 剂,持续 48 小时,与插入宫颈上 Foley 导管 48 小时相比,用于引产(IOL)的可行性,并比较两种方法的有效性。

方法

2016 年 10 月 13 日至 2017 年 4 月 30 日,在加勒教学医院 Mahamodara 的学术产科单位进行了一项研究者盲、随机对照试验。将 144 例具有单胎、无并发症妊娠的妇女(MBS<5)纳入研究,这些妇女在 40 周+5 天妊娠时进行了分层(初产妇/多产妇)随机分组,分别接受每天 4 小时口服 50µg OM,每天 3 剂,持续 48 小时,或宫颈上 Foley 导管,持续 48 小时。

结果

与 Foley 相比,OM 组的 IOL 成功率更高(67% vs 47%,RR 1.4,95%CI 1.1-2.0,p=0.029),24 小时和 48 小时内阴道分娩率更高,平均引产分娩间隔更短,48 小时后未临产时平均 MBS 增加更大。虽然 OM 后子宫过度活动、胎心监护异常和胎粪污染羊水的频率增加,但无统计学意义,但两组之间剖宫产率、产妇或新生儿发病率或死亡率无差异。

结论

在 40 周+5 天妊娠的妇女中,每天 4 小时口服米索前列醇(OM)50μg,每天 3 剂,持续 48 小时,与插入宫颈上 Foley 导管 48 小时一样可行,但 OM 比 Foley 导管更有效用于 IOL。

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