Stafford Irene A, Garite Thomas J, Maurel Kimberly, Combs C Andrew, Heyborne Kent, Porreco Richard, Nageotte Michael, Baker Susan, Gopalani Sameer, Dola Chi, How Helen, Das Anita F
Department of Obstetrics and Gynecology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.
Touro Infirmary, Louisiana State University Health Science Center, New Orleans, Louisiana.
AJP Rep. 2019 Apr;9(2):e160-e166. doi: 10.1055/s-0039-1687871. Epub 2019 Apr 30.
This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation. This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues. Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; = 0.1264) as well. Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.
这项多中心随机对照试验比较了宫颈托（CP）与期待治疗（EM）在孕周为22.0至32.0周的前置胎盘女性中延长孕周至≥36.0周的效果。 本研究于2016年11月至2018年6月进行。女性被随机分为接受Bioteque宫颈托或期待治疗。除非有指征，宫颈托在≥36.0周时取出。主要结局是分娩时的孕周，次要结局包括输血需求、产前入院次数和时长、分娩方式及新生儿结局。宫颈托组需要140名患者才能显示出妊娠延长3周；然而，由于预算问题，试验提前终止。 在33名符合条件的女性中，17名被纳入研究。虽然无统计学意义，但宫颈托组分娩时的平均孕周大于期待治疗组女性（36.5±1.23 vs. 36.0±2.0；P = 0.1673）。期待治疗组的产前入院次数和时长也更多（2.7±0.58 vs. 16.0±22.76天；P = 0.1264）。 尽管该研究不足以确定主要结局，但证明了宫颈托在前置胎盘妊娠中的安全性和可行性。
