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阴道使用月见草油与米索前列醇对初产妇宫颈准备效果的比较研究:一项双盲临床试验

Comparative Study of the Effect of Vaginal use of Primrose Oil with Misoprostol on Cervical Preparation of Prim Gravid Women: A Double-blind Clinical Trial.

作者信息

Shahraki Azar Danesh, Mirhoseini Sara, Movahedi Minoo, Hajihashemy Maryam, Haghollahi Fedyeh

机构信息

Department of Obstetrics and Gynecology, Shahid Beheshti Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Obstetrics and Gynecology, School of Medicine, Isfahan University of Medical Science, Isfahan, Iran.

出版信息

Adv Biomed Res. 2023 Mar 28;12:78. doi: 10.4103/abr.abr_30_22. eCollection 2023.

Abstract

BACKGROUND

This study compares the effect of vaginal administration of evening primrose oil with misoprostol on cervical preparation in prim gravid women at ≥40 weeks gestation.

MATERIALS AND METHODS

This was a double-blind randomized clinical trial conducted in Isfahan, Iran during 2019-2020 on 110 prim gravid pregnant women with a gestational age of 40 weeks and more and cephalic presentation of the fetus with the obstetrical indication for pregnancy termination. After obstetric examinations to rule out cephalo pelvic disproportion and calculation of the Bishop score by the researcher, patients were randomized to receive 25 μg misoprostol tablets ( = 55) or 1000 mg evening primrose oil Pearls ( = 55) administrated vaginally by a midwife. We compared Bishop's score before and after the intervention, time of cervical ripening, a dose of intervention for cervical ripening, need to induce labor, the interval between cervical preparation and induction of labor, duration of oxytocin use, need for cesarean section, and its cause, Apgar score at 5 and 10 minutes, neonatal birth weight.

RESULTS

Mean baseline Bishop Score was not significant between the groups ( = 0.45); after the intervention, it was significantly higher in the primrose oil group ( < .001). Significantly fewer patients required cesarean sections in the primrose oil group ( = 0.03). The other outcomes were. not significant between the groups ( > 0.05).

CONCLUSION

Misoprostol and primrose oil administration appear to positively affect cervical readiness. Primrose oil resulted in significantly better Bishop Scores and fewer cesarean sections compared to misoprostol in pregnancy 40 weeks and more.

摘要

背景

本研究比较了在妊娠≥40周的初产妇中,阴道给予月见草油与米索前列醇对宫颈准备的效果。

材料与方法

这是一项双盲随机临床试验,于2019年至2020年在伊朗伊斯法罕对110名妊娠40周及以上、胎儿头先露且有产科终止妊娠指征的初产妇进行。在进行产科检查以排除头盆不称并由研究人员计算Bishop评分后,患者被随机分为接受25μg米索前列醇片(n = 55)或1000mg月见草油软胶囊(n = 55),由助产士经阴道给药。我们比较了干预前后的Bishop评分、宫颈成熟时间、宫颈成熟的干预剂量、引产需求、宫颈准备与引产之间的间隔、缩宫素使用时间、剖宫产需求及其原因、5分钟和10分钟时的Apgar评分、新生儿出生体重。

结果

两组间平均基线Bishop评分无显著差异(P = 0.45);干预后,月见草油组显著更高(P <.001)。月见草油组剖宫产的患者明显更少(P = 0.03)。其他结果在两组间无显著差异(P > 0.05)。

结论

米索前列醇和月见草油给药似乎对宫颈准备有积极影响。在妊娠40周及以上时,与米索前列醇相比,月见草油导致Bishop评分显著更好,剖宫产更少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8a7/10186053/56b8916dbfee/ABR-12-78-g001.jpg

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