Department of Obstetrics and Gynecology, Amsterdam UMC location, University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam Reproduction and Development Institute, Amsterdam, The Netherlands.
Ultrasound Obstet Gynecol. 2022 Jun;59(6):771-777. doi: 10.1002/uog.24821.
To evaluate the effect of cervical pessary, as a strategy to prevent preterm birth (PTB), on the outcome of subsequent pregnancy and maternal quality of life 4 years after the index twin pregnancy.
Between 2009 and 2012, the ProTWIN trial randomized women with a multiple pregnancy to pessary use vs standard care for the prevention of PTB. The trial showed no benefit in unselected women with a twin pregnancy, but showed a 60% reduction in poor perinatal outcomes in favor of the pessary group in the subgroup of women with a mid-trimester short cervix (cervical length < 38 mm). All women were invited to participate in a follow-up study 4 years after their participation in the ProTWIN trial. In this follow-up study, maternal quality of life was assessed using the EQ-5D-3L questionnaire and women were asked separate questions about subsequent pregnancies. Results were compared between women who were randomized to the pessary vs the control group in the ProTWIN trial by calculating relative risk (RR) and 95% CI. Subgroup analysis was performed for women with a mid-trimester short cervix (cervical length < 38 mm).
Of the 813 women included in the ProTWIN trial, 408 (50.2%) participated in this follow-up study, comprising 228 randomized to the pessary group and 180 to the control group in the original trial. The median interval between participation in the ProTWIN trial and participation in this follow-up study was 4.1 (interquartile range (IQR), 3.9-7.1) years. Ninety-eight (24.0%) participants tried to conceive after their participation in the ProTWIN trial. Of those, 22 (22.4%) women did not have a subsequent pregnancy (no difference between pessary and control groups), seven (7.1%) women had at least one miscarriage but no live birth, and 67 (68.4%) women had at least one live birth (35 in the pessary vs 32 in the control group; RR, 0.93 (95% CI, 0.8-1.07)). In two women, the pregnancy outcome was unknown. Preterm delivery (< 37 weeks of gestation) of the first live birth occurred in three women in the pessary vs one woman in the control group (all singleton; RR, 2.57 (95% CI, 0.28-23.44)). No differences were found between the pessary and control groups in the subgroup of women with mid-trimester short cervix, but the numbers analyzed were small. The median health state index score was 0.95 (IQR, 0.82-0.95), with no difference between the pessary and control groups.
Our findings suggest that there are no long-term effects of pessary use on the outcome of subsequent pregnancies and maternal quality of life. Data on obstetric outcome were limited due to the small numbers. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
评估宫颈托作为预防早产（PTB）的策略，对指数双胞胎妊娠后后续妊娠结局和产妇生活质量的影响。
在 2009 年至 2012 年期间，ProTWIN 试验将多胎妊娠的妇女随机分为使用宫颈托组和标准护理组，以预防 PTB。该试验显示，在未选择的双胞胎妊娠妇女中没有获益，但在中孕期短宫颈（宫颈长度<38mm）的亚组中，宫颈托组在围产期不良结局方面降低了 60%。所有妇女均被邀请在参加 ProTWIN 试验后 4 年参加随访研究。在这项随访研究中，使用 EQ-5D-3L 问卷评估产妇生活质量，并单独询问妇女关于后续妊娠的问题。通过计算相对风险（RR）和 95%置信区间（CI），比较 ProTWIN 试验中随机分配至宫颈托组和对照组的妇女的结果。对中孕期短宫颈（宫颈长度<38mm）的妇女进行亚组分析。
在 ProTWIN 试验中纳入的 813 名妇女中，408 名（50.2%）参加了这项随访研究，其中 228 名随机分配至宫颈托组，180 名随机分配至对照组。参加 ProTWIN 试验和这项随访研究之间的中位时间间隔为 4.1（四分位间距（IQR），3.9-7.1）年。98 名（24.0%）参与者在参加 ProTWIN 试验后尝试怀孕。其中，22 名（22.4%）妇女没有后续妊娠（宫颈托组和对照组之间无差异），7 名（7.1%）妇女至少有一次流产但无活产，67 名（68.4%）妇女至少有一次活产（35 名在宫颈托组，32 名在对照组；RR，0.93（95%CI，0.8-1.07））。有两名妇女的妊娠结局未知。在宫颈托组中，有 3 名妇女出现了首次活产的早产（<37 周妊娠），而对照组中只有 1 名妇女（均为单胎；RR，2.57（95%CI，0.28-23.44））。在中孕期短宫颈的亚组中，宫颈托组和对照组之间没有发现差异，但分析的数量较少。中位健康状态指数评分均为 0.95（IQR，0.82-0.95），宫颈托组和对照组之间无差异。
我们的研究结果表明，宫颈托的使用对后续妊娠结局和产妇生活质量没有长期影响。由于数量有限，关于产科结局的数据有限。© 2021 作者。由 John Wiley & Sons Ltd 代表国际妇产科超声学会出版超声在妇产科杂志。
