Maternal-Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
Maternal-Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain; Maternal and Child Health and Development Network (SAMID), Instituto Salud Carlos III, Madrid, Spain.
Am J Obstet Gynecol. 2018 Jul;219(1):99.e1-99.e16. doi: 10.1016/j.ajog.2018.04.031. Epub 2018 Apr 25.
To date, no intervention has proved effective in reducing the spontaneous preterm birth rate in singleton pregnancies following an episode of threatened preterm labor and short cervix remaining.
This study was designed to ascertain whether cervical pessaries could be useful in preventing spontaneous preterm birth in women with singleton pregnancies and a short cervix after a threatened preterm labor episode.
This open randomized controlled trial was conducted in 357 pregnant women (between 24-33 weeks) who had not delivered 48 hours after a threatened preterm labor episode and had a short cervix remaining (≤25 mm at 24-29 weeks; ≤15 mm at 30-33 weeks). Patients were randomly assigned to cervical pessary (179) or routine management (178). The primary outcome was the spontaneous preterm birth rate <34 weeks. Spontaneous preterm birth <28 and 37 weeks and neonatal morbidity and mortality were also evaluated in an intention-to-treat analysis.
No significant differences between the pessary and routine management groups were observed in the spontaneous preterm birth rate <34 weeks (19/177 [10.7%] in the pessary group vs 24/175 [13.7%] in the control group; relative risk, 0.78; 95% confidence interval, 0.45-1.38). Spontaneous preterm birth <37 weeks occurred less frequently in the pessary group (26/175 [14.7%] vs 44/175 [25.1%]; relative risk, 0.58; 95% confidence interval, 0.38-0.90; P = .01). Preterm premature rupture of membranes rate was significantly lower in pessary carriers (4/177 [2.3%] vs 14/175 [8.0%]; relative risk, 0.28; 95% confidence interval, 0.09-0.84; P = .01). The pessary group less frequently required readmission for new threatened preterm labor episodes (8/177 [4.5%] vs 35/175 [20.0%]; relative risk, 0.23; 95% confidence interval, 0.11-0.47; P < .0001). No serious adverse maternal events occurred; neonatal morbidity and mortality were similar in both groups.
Pessary use did not significantly lower the spontaneous preterm birth rate <34 weeks in women with a short cervix remaining after a threatened preterm labor episode but did significantly reduce the spontaneous preterm birth rate <37 weeks, threatened preterm labor recurrence, and the preterm premature rupture of membranes rate.
迄今为止，尚无干预措施被证明能有效降低既往有早产先兆和宫颈管缩短病史的单胎妊娠自发性早产率。
本研究旨在确定宫颈托是否可用于预防既往有早产先兆和宫颈管缩短病史的单胎妊娠自发性早产。
本开放性随机对照试验纳入了 357 例（妊娠 24-33 周）孕妇，这些孕妇在早产先兆发作后 48 小时内未分娩，且宫颈管仍较短（妊娠 24-29 周时≤25 mm；妊娠 30-33 周时≤15 mm）。患者被随机分配至宫颈托组（179 例）或常规管理组（178 例）。主要结局为自发性早产率<34 周。采用意向治疗分析评估自发性早产率<28 周和 37 周以及新生儿发病率和死亡率。
宫颈托组和常规管理组在自发性早产率<34 周方面无显著差异（宫颈托组 177 例中有 19 例[10.7%]，常规管理组 175 例中有 24 例[13.7%]；相对风险，0.78；95%置信区间，0.45-1.38）。宫颈托组自发性早产率<37 周的发生率较低（宫颈托组 175 例中有 26 例[14.7%]，常规管理组 175 例中有 44 例[25.1%]；相对风险，0.58；95%置信区间，0.38-0.90；P=0.01）。胎膜早破的发生率在宫颈托使用者中明显较低（宫颈托组 177 例中有 4 例[2.3%]，常规管理组 175 例中有 14 例[8.0%]；相对风险，0.28；95%置信区间，0.09-0.84；P=0.01）。宫颈托组因新发早产先兆再次入院的比例较低（宫颈托组 177 例中有 8 例[4.5%]，常规管理组 175 例中有 35 例[20.0%]；相对风险，0.23；95%置信区间，0.11-0.47；P<0.0001）。两组均未发生严重的母体不良事件；新生儿发病率和死亡率相似。
宫颈托的使用并未显著降低既往有早产先兆和宫颈管缩短病史的单胎妊娠自发性早产率<34 周，但显著降低了自发性早产率<37 周、早产先兆复发率和胎膜早破率。
