{"title":"局部使用硫酸镁对产程和分娩体验的影响:随机对照试验。","authors":"Sahar Rouhzendeh, Sanaz Mousavi, Mojgan Mirghafourvand, Sakineh Mohammad-Alizadeh-Charandabi","doi":"10.1186/s12884-024-06831-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Magnesium sulfate is used topically to reduce the duration of labor in some regions of the country. However, there is insufficient evidence about its effectiveness. This study aimed to determine whether topical magnesium sulfate reduces labor duration and improves childbirth experience (primary outcomes).</p><p><strong>Methods: </strong>In this randomized controlled trial, the participants were 98 women with low-risk, singleton, and full-term pregnancies admitted to a teaching hospital in Iran. They were randomly assigned to the intervention group (receiving 50% magnesium sulfate) or the control group (receiving distilled water) stratified by parity and onset of labor. The participants, interventionists, and data collectors were blinded. During the vaginal examination at the beginning of the active phase of labor, 10 mL of magnesium sulfate or distilled water was poured on the cervix of the uterus. Data collection was performed by the researcher with continuous monitoring up to two hours post-delivery and follow-up at 4-5 weeks postpartum. The Childbirth Experience Questionnaire 2.0 was used to examine childbirth experience. We performed a modified intention-to-treat analysis, excluding those whose outcome of interest could not be assessed. Independent-samples t-tests were used to compare the groups in terms of the mean of the primary outcomes.</p><p><strong>Results: </strong>Participant recruitment took place between December 2021 and December 2022. Thirty-three percent were primiparous and 37% had induced labor. Three women in the intervention group and seven in the control group underwent emergency cesarean sections. All 49 women assigned to each group were included in the analysis of labor duration outcome, while one and two women were excluded from the analysis of childbirth experience score due to loss to follow-up. In the intervention group, compared to the control group, the mean duration of the intervention until delivery was significantly shorter (1.59 vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]) and the childbirth experience score was higher (3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]).</p><p><strong>Conclusions: </strong>According to the results of this trial, pouring 10 mL of 50% magnesium sulfate on the cervix at the beginning of the active phase of labor probably reduces labor duration and improves the childbirth experience.</p><p><strong>Trial registration: </strong>Ethics Committee of Tabriz University of Medical Sciences: IR.TBZMED.REC. 1400.726. Iranian Registry of Clinical Trials: IRCT20100414003706N40 Registration date: 21/11/2021 ( https://en.irct.ir/trial/58323 ).</p>","PeriodicalId":9033,"journal":{"name":"BMC Pregnancy and Childbirth","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523604/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of topical magnesium sulfate on labor duration and childbirth experience: a randomized controlled trial.\",\"authors\":\"Sahar Rouhzendeh, Sanaz Mousavi, Mojgan Mirghafourvand, Sakineh Mohammad-Alizadeh-Charandabi\",\"doi\":\"10.1186/s12884-024-06831-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Magnesium sulfate is used topically to reduce the duration of labor in some regions of the country. However, there is insufficient evidence about its effectiveness. This study aimed to determine whether topical magnesium sulfate reduces labor duration and improves childbirth experience (primary outcomes).</p><p><strong>Methods: </strong>In this randomized controlled trial, the participants were 98 women with low-risk, singleton, and full-term pregnancies admitted to a teaching hospital in Iran. They were randomly assigned to the intervention group (receiving 50% magnesium sulfate) or the control group (receiving distilled water) stratified by parity and onset of labor. The participants, interventionists, and data collectors were blinded. During the vaginal examination at the beginning of the active phase of labor, 10 mL of magnesium sulfate or distilled water was poured on the cervix of the uterus. Data collection was performed by the researcher with continuous monitoring up to two hours post-delivery and follow-up at 4-5 weeks postpartum. The Childbirth Experience Questionnaire 2.0 was used to examine childbirth experience. We performed a modified intention-to-treat analysis, excluding those whose outcome of interest could not be assessed. Independent-samples t-tests were used to compare the groups in terms of the mean of the primary outcomes.</p><p><strong>Results: </strong>Participant recruitment took place between December 2021 and December 2022. Thirty-three percent were primiparous and 37% had induced labor. Three women in the intervention group and seven in the control group underwent emergency cesarean sections. All 49 women assigned to each group were included in the analysis of labor duration outcome, while one and two women were excluded from the analysis of childbirth experience score due to loss to follow-up. In the intervention group, compared to the control group, the mean duration of the intervention until delivery was significantly shorter (1.59 vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]) and the childbirth experience score was higher (3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]).</p><p><strong>Conclusions: </strong>According to the results of this trial, pouring 10 mL of 50% magnesium sulfate on the cervix at the beginning of the active phase of labor probably reduces labor duration and improves the childbirth experience.</p><p><strong>Trial registration: </strong>Ethics Committee of Tabriz University of Medical Sciences: IR.TBZMED.REC. 1400.726. 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引用次数: 0
摘要
背景:在该国的一些地区,硫酸镁被局部用于缩短分娩时间。然而,有关其有效性的证据不足。本研究旨在确定局部使用硫酸镁是否能缩短产程并改善分娩体验(主要结果):在这项随机对照试验中,参与者是伊朗一家教学医院收治的 98 名低风险单胎足月妊娠妇女。她们被随机分配到干预组(接受 50%硫酸镁治疗)或对照组(接受蒸馏水治疗),并按胎次和分娩时间进行分层。参与者、干预者和数据收集者均为盲人。在分娩活跃期开始时进行阴道检查,将 10 毫升硫酸镁或蒸馏水倒在子宫颈上。数据收集由研究人员进行,持续监测至分娩后两小时,并在产后 4-5 周进行随访。分娩体验问卷 2.0 用于调查分娩体验。我们进行了修改后的意向治疗分析,排除了无法评估相关结果的产妇。采用独立样本 t 检验比较各组主要结果的平均值:参与者招募于 2021 年 12 月至 2022 年 12 月进行。33%为初产妇,37%为引产。干预组和对照组分别有 3 名和 7 名产妇接受了紧急剖宫产手术。干预组和对照组分别有3名和7名产妇接受了紧急剖宫产手术。每组的49名产妇均纳入了产程结果分析,但有1名和2名产妇因失去随访而被排除在分娩体验评分分析之外。与对照组相比,干预组的平均分娩持续时间明显缩短(1.59 h vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]),分娩体验评分更高(3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]):试验登记:大不里士医科大学伦理委员会:试验注册:大不里士医科大学伦理委员会:IR.TBZMED.REC.1400.726.伊朗临床试验登记处:IRCT20100414003706N40 注册日期:2021 年 11 月 21 日 ( https://en.irct.ir/trial/58323 )。
Effect of topical magnesium sulfate on labor duration and childbirth experience: a randomized controlled trial.
Background: Magnesium sulfate is used topically to reduce the duration of labor in some regions of the country. However, there is insufficient evidence about its effectiveness. This study aimed to determine whether topical magnesium sulfate reduces labor duration and improves childbirth experience (primary outcomes).
Methods: In this randomized controlled trial, the participants were 98 women with low-risk, singleton, and full-term pregnancies admitted to a teaching hospital in Iran. They were randomly assigned to the intervention group (receiving 50% magnesium sulfate) or the control group (receiving distilled water) stratified by parity and onset of labor. The participants, interventionists, and data collectors were blinded. During the vaginal examination at the beginning of the active phase of labor, 10 mL of magnesium sulfate or distilled water was poured on the cervix of the uterus. Data collection was performed by the researcher with continuous monitoring up to two hours post-delivery and follow-up at 4-5 weeks postpartum. The Childbirth Experience Questionnaire 2.0 was used to examine childbirth experience. We performed a modified intention-to-treat analysis, excluding those whose outcome of interest could not be assessed. Independent-samples t-tests were used to compare the groups in terms of the mean of the primary outcomes.
Results: Participant recruitment took place between December 2021 and December 2022. Thirty-three percent were primiparous and 37% had induced labor. Three women in the intervention group and seven in the control group underwent emergency cesarean sections. All 49 women assigned to each group were included in the analysis of labor duration outcome, while one and two women were excluded from the analysis of childbirth experience score due to loss to follow-up. In the intervention group, compared to the control group, the mean duration of the intervention until delivery was significantly shorter (1.59 vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]) and the childbirth experience score was higher (3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]).
Conclusions: According to the results of this trial, pouring 10 mL of 50% magnesium sulfate on the cervix at the beginning of the active phase of labor probably reduces labor duration and improves the childbirth experience.
Trial registration: Ethics Committee of Tabriz University of Medical Sciences: IR.TBZMED.REC. 1400.726. Iranian Registry of Clinical Trials: IRCT20100414003706N40 Registration date: 21/11/2021 ( https://en.irct.ir/trial/58323 ).
期刊介绍:
BMC Pregnancy & Childbirth is an open access, peer-reviewed journal that considers articles on all aspects of pregnancy and childbirth. The journal welcomes submissions on the biomedical aspects of pregnancy, breastfeeding, labor, maternal health, maternity care, trends and sociological aspects of pregnancy and childbirth.