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产妇第二产程中安排两名助产士可有效降低严重会阴创伤风险
作者:小柯机器人 发布时间:2022/3/20 14:49:12

瑞典卡罗琳斯卡学院Malin Edqvist团队研究了两名助产士在第二产程对减少严重会阴创伤的效果。相关论文于2022年3月15日发表在《柳叶刀》杂志上。

影响肛门括约肌复合体的严重会阴创伤(SPT)是分娩后的一种严重并发症,与产妇的短期和长期发病率相关。有效的预防策略仍然缺乏。该研究旨在检验这样一种假设,即在第二产程中,为了预防SPT,如果有第二名助产士在场,影响肛门括约肌的伤害会比只有一名助产士在场时少。

研究组在瑞典五个产科单位进行了一项多中心、随机、平行对照组、无掩盖试验,在第二产程晚期,待产妇被随机分配到由一名或两名助产士协助。18-47岁的初产妇和头胎剖腹产但想尝试阴道分娩的产妇在进入第二产程时被随机分配到干预组。

进一步的纳入标准为孕周37+0,头位单胎活胎,精通瑞典语、英语、阿拉伯语或波斯语。排除标准为多胎妊娠、宫内胎儿死亡、计划剖腹产或怀孕少于37周的妇女。将符合条件的孕妇随机分组,干预组中有两名助产士,标准护理组有一名助产士。

所有的产妇和助产士都知道小组分配,但进行分析的统计学家对小组分配不知情。指导助产士实施现有的预防模式,第二名助产士在被要求时协助初级助产士的指导。助产士还被要求填写病例报告表,详细说明协助技术和会阴创伤预防技术。主要结局是患SPT的女性比例,计算其优势比(OR)和95%CI,并进行逻辑回归以校正研究机构。所有分析均根据治疗意向进行。

2018年12月10日至2020年3月21日,共有8866名女性接受了资格评估,4264名女性符合入选标准并同意参加。4264名女性中有3776名(88.5%)在进入第二产程后被随机分组。1892名妇女在第二产程中被分配到干预组(两名助产士),1884名妇女被分配到标准护理组(一名助产士)。

每组有13名女性不符合纳入标准,被排除在外。在进一步排除后,干预组有1546名妇女自然分娩,标准护理组有1513名,均被纳入主要结局的意向治疗分析。干预组中的SPT发生率为3.9%(1546例中有61例),显著低于标准护理组的5.7%(1513例中有86例),校正后的OR为0.69。

研究结果表明,在活跃的第二产程,两名助产士的出现可以降低首次自然分娩产妇的SPT风险。

附:英文原文

Title: The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus): a multicentre, randomised controlled trial in Sweden

Author: Malin Edqvist, Hannah G Dahlen, Cecilia Hggsgrd, Helena Tern, Karin ngeby, Pia Teleman, Gunilla Ajne, Christine Rubertsson

Issue&Volume: 2022-03-15

Abstract:

Background

Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.

Methods

In this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18–47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.

Findings

Between Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49–0·97).

Interpretation

The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.

DOI: 10.1016/S0140-6736(22)00188-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00188-X/fulltext

 

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
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投稿链接:http://ees.elsevier.com/thelancet