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早产时服用孕酮片与肌内注射孕酮后新生儿结局的比较:一项随机对照试验。

A comparison of neonatal outcomes after taking progesterone pills and progesterone intramuscular injections in preterm labor: An RCT.

作者信息

Dalili Maryam, Barkhori-Mehni Moeeneh, Karami Robati Fatemeh

机构信息

Department of Obstetrics and Gynecology, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.

Maternal-Metal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Int J Reprod Biomed. 2023 Aug 23;21(7):531-540. doi: 10.18502/ijrm.v21i7.13888. eCollection 2023 Aug.

Abstract

BACKGROUND

Approximately two-thirds of infant mortality within the first year of life are caused by preterm labor (PL).

OBJECTIVE

This study aimed to investigate the effects of progesterone-based compounds to prevent PL.

MATERIALS AND METHODS

This randomized clinical trial study was conducted on 146 pregnant women admitted to Department of Obstetrics and Gynecology, Afzalipour hospital in Kerman University of Medical Sciences, Kerman, Iran in June 2019. The participants with PL received Tocolytic and 12 mg Betamethasone in 2 doses over 2 days to mature the fetus's lungs. Stopping PL was considered a 12-hr period without any contractions after finishing the Tocolytic. Following the successful cessation of PL, the participants were monitored for 48 hr. Subsequently, the participants were divided into 2 groups. Participants received 200 mg Lutogel capsules orally per day in group A while group B received a weekly dose of 250 mg Proluton in the form of intramuscular injection, respectively. Treatment in groups continued until the 36 wk of delivery. The participants were followed-up weekly, and if any signs of PL were detected, an obstetrician carried out a vaginal examination.

RESULTS

The incidence of PL was the same in both groups. There was no significant difference in the latent phase, average birth weight, and the neonatal intensive care unit admission frequency (p = 0.07, 0.17, 0.58, respectively) between groups.

CONCLUSION

No difference in the results obtained from theneonataloutcomes evaluated in groups. Both medications similarly led to recovering pregnancy and neonatal outcomes caused by PL. Applying the oral form with similar beneficial effects were pointed out in this study, which can be a solution to the issues caused by numerous injections that are inevitable in the injected administration of this medicine.

摘要

背景

一岁以内婴儿死亡中约三分之二是由早产(PL)引起的。

目的

本研究旨在调查基于孕酮的化合物预防早产的效果。

材料与方法

这项随机临床试验于2019年6月在伊朗克尔曼医科大学阿夫扎利普尔医院妇产科收治的146名孕妇中进行。患有早产的参与者接受了宫缩抑制剂,并在两天内分两剂注射12毫克倍他米松以使胎儿肺部成熟。停止宫缩被定义为在使用宫缩抑制剂后12小时内无任何宫缩。在成功停止早产之后,对参与者进行48小时的监测。随后,将参与者分为两组。A组参与者每天口服200毫克黄体酮凝胶胶囊,而B组参与者分别接受每周一次250毫克黄体酮的肌肉注射。两组的治疗持续到分娩36周。每周对参与者进行随访,如果检测到任何早产迹象,由产科医生进行阴道检查。

结果

两组早产的发生率相同。两组之间在潜伏期、平均出生体重和新生儿重症监护病房入院频率方面无显著差异(p值分别为0.07、0.17、0.58)。

结论

两组评估的新生儿结局结果无差异。两种药物同样导致因早产引起的妊娠恢复和新生儿结局。本研究指出了具有相似有益效果的口服剂型,这可以解决该药物注射给药中不可避免的多次注射所带来的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea3a/10505697/759783b8ff16/ijrb-21-531-g001.jpg

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