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瑞典过期引产研究(SWEPIS)中女性的分娩经历:一项多中心、随机对照试验。

Women's childbirth experiences in the Swedish Post-term Induction Study (SWEPIS): a multicentre, randomised, controlled trial.

作者信息

Nilvér Helena, Wessberg Anna, Dencker Anna, Hagberg Henrik, Wennerholm Ulla-Britt, Fadl Helena, Wesström Jan, Sengpiel Verena, Lundgren Ingela, Bergh Christina, Wikström Anna-Karin, Saltvedt Sissel, Elden Helen

机构信息

Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden

Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden.

出版信息

BMJ Open. 2021 Apr 7;11(4):e042340. doi: 10.1136/bmjopen-2020-042340.

Abstract

OBJECTIVE

To compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.

DESIGN

A register-based, multicentre, randomised, controlled, superiority trial.

SETTING

Women were recruited at 14 hospitals in Sweden, 2016-2018.

PARTICIPANTS

Women with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.

INTERVENTIONS

The women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).

OUTCOME MEASURES

As main outcome, women's childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1-10) within 3 days after delivery at the remaining eleven hospitals.

RESULTS

The total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: (2.8 vs 2.7, p=0.09), (3.3 vs 3.2, p=0.06) and (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22).

CONCLUSIONS

There were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.

TRIAL REGISTRATION NUMBER

ISRCTN26113652.

摘要

目的

在瑞典过期引产研究中,比较随机分配至41周引产或期待治疗至42周的女性的分娩体验。

设计

一项基于登记的多中心随机对照优效性试验。

设置

2016年至2018年期间,在瑞典的14家医院招募女性。

参与者

在妊娠41周时招募单胎妊娠且无并发症的女性。

干预措施

将女性随机分配至41周引产(引产组,n = 1381)或期待治疗至42周(期待治疗组,n = 1379)。

结局指标

作为主要结局,在三家医院产后3个月时,使用分娩体验问卷第2版(CEQ2)对656名女性的分娩体验进行测量。作为探索性结局,在其余11家医院分娩后3天内,使用视觉模拟量表(VAS 1 - 10)对1457名女性的总体分娩体验进行测量。

结果

总应答率为77%(2113/2760)。两组(引产组,n = 354;期待治疗组,n = 302)在以下子量表中,用CEQ2测量的分娩体验无显著差异:(2.8对2.7,p = 0.09)、(3.3对3.2,p = 0.06)和(3.6对3.5,p = 0.38),或在CEQ2总分中(3.3对3.2,p = 0.07)。引产组女性在子量表中得分更高(3.6对3.4,p = 0.02),尽管效应量较小(0.19)。根据VAS测量的总体分娩体验无显著差异(8.0(n = 735)对8.1(n = 735),p = 0.22)。

结论

随机分配至41周引产或期待治疗至42周的女性,根据CEQ2或用VAS评估的总体分娩体验,其分娩体验无差异。总体而言,女性对其分娩体验评价较高。

试验注册号

ISRCTN26113652。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/45dd/8031013/af96c01aa80c/bmjopen-2020-042340f01.jpg

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