枸橼酸西地那非能否降低分娩期急诊剖宫产及胎儿窘迫的发生率？一项随机双盲临床试验。

Dose Sildenafil Citrate Reduce the Incidence of Emergency Cesarean Section and Fetal Distress During Labor? A Randomized Double-Blinded Clinical Trial.

作者信息

Sharami Seyedeh Hajar, Milani Forozan, Kabodmehri Roya, Naghdipour Misa, Mahmoudi Isaabadi Azade, Haghparast Ghadim-Limudahi Zahra

机构信息

Reproductive Health Research Center, Department of Obstetrics and Gynecology, School of Medicine, Al-Zahra Hospital, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

J Reprod Infertil. 2024 Jan-Mar;25(1):46-55. doi: 10.18502/jri.v25i1.15198.

DOI:10.18502/jri.v25i1.15198

PMID:39157279

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11330200/

Abstract

BACKGROUND

Fetal distress (FD) is one of the most frequent causes of emergency cesarean section (CS) due to the insufficient uteroplacental blood supply during labor. There is a theory that Sildenafil citrate (SC) may improve the uteroplacental blood supply and decrease fetal hypoxia and FD.

METHODS

In a randomized double-blinded clinical trial, a total of 208 low-risk subjects who met our stringent inclusion criteria were randomly assigned into two groups: the Sildenafil citrate group (n=104) and the placebo group (n=104). These participants were referred to our referral gynecology and obstetrics department for delivery between July 2022 to September 2022. The SC group received oral SC at a dose of 50 every 6 , up to a maximum of three times. The final maternal-fetal-neonatal results were recorded and all data were analyzed using SPSS version 23.

RESULTS

The mean age of mothers was 28.98±5.6 years and 120 cases were primigravid (57.7%). Out of a total of 208 pregnant subjects, 168 subjects delivered through normal vaginal delivery (80.8%) and 40 cases underwent emergency CS (19.2%). The number of NVD in Sildenafil group was significantly more than placebo group (87.5% . 74%) and SC decreased the rate of emergency CS to 87.5% (RR=2.46%, 95%CI 1.19-5.08). Also, SC decreased the rate of FD to 53.8% (RR=2.83%, 95%CI of 1-8.24).

CONCLUSION

The results showed that SC can effectively decrease the rate of emergency CS and FD during labor.

摘要

背景

胎儿窘迫（FD）是分娩期间因子宫胎盘血供不足导致紧急剖宫产（CS）的最常见原因之一。有一种理论认为，枸橼酸西地那非（SC）可能改善子宫胎盘血供并减少胎儿缺氧和胎儿窘迫。

方法

在一项随机双盲临床试验中，共有208名符合我们严格纳入标准的低风险受试者被随机分为两组：枸橼酸西地那非组（n = 104）和安慰剂组（n = 104）。这些参与者于2022年7月至2022年9月被转介到我们的妇产科转诊部门进行分娩。SC组每6小时口服50毫克SC，最多服用三次。记录最终的母婴及新生儿结局，并使用SPSS 23版对所有数据进行分析。

结果

母亲的平均年龄为28.98±5.6岁，初产妇120例（57.7%）。在总共208名怀孕受试者中，168名受试者通过正常阴道分娩（80.8%），40例接受了紧急剖宫产（19.2%）。西地那非组正常阴道分娩的数量明显多于安慰剂组（87.5%对74%），SC将紧急剖宫产率降至87.5%（RR = 2.46%，95%CI 1.19 - 5.08）。此外，SC将胎儿窘迫率降至53.8%（RR = 2.83%，95%CI 1 - 8.24）。