Guinn D A, Goepfert A R, Owen J, Wenstrom K D, Hauth J C
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, USA.
Am J Obstet Gynecol. 1998 Oct;179(4):874-8. doi: 10.1016/s0002-9378(98)70181-4.
This study's aim was to determine whether maintenance therapy with terbutaline administered by pump prolongs gestation in women after treatment with intravenous magnesium sulfate tocolysis for suspected preterm labor.
Consenting women with a singleton gestation and intact membranes who had uterine contractions and >1 cm cervical dilation, 80% effacement, or progressive cervical change and whose contractions were successfully arrested with intravenous magnesium were randomly assigned to receive either terbutaline or normal saline solution placebo by subcutaneous infusion pump. Pump therapy was administered with a standardized protocol. Pump therapy was discontinued and parenteral magnesium was resumed if recurrent preterm labor developed while women were on the therapeutic regimen at <34 weeks' gestation and no contraindication for tocolysis existed. If recurrent labor was arrested, pump therapy was restarted according to the original treatment group. A sample size of 48 women was required to detect a 2-week intergroup difference in mean time to delivery. Analyses were based on intent to treat.
Fifty-two women received terbutaline (n = 24) or placebo (n = 28). At random assignment the groups were similar with respect to age, race, parity, previous preterm delivery, gestational age, and cervical examination. Overall there was a 1-day difference in mean time to delivery between the groups (terbutaline 29 +/- 22 days and placebo 28 +/- 23 days, P = .78). There were no differences in the rates of preterm delivery at <34 and <37 weeks' gestation. Neonatal outcomes were similar.
Maintenance terbutaline therapy administered by pump does not prolong gestation in women successfully treated for suspected preterm labor.
本研究旨在确定对于疑似早产且经静脉硫酸镁抑制宫缩治疗后的女性，使用泵注特布他林进行维持治疗是否能延长孕周。
同意参与研究的单胎妊娠且胎膜完整、有子宫收缩且宫颈扩张>1cm、宫颈消退80%或宫颈有进展性变化，且静脉注射硫酸镁成功抑制宫缩的女性，被随机分配通过皮下输液泵接受特布他林或生理盐水安慰剂治疗。泵注治疗按照标准化方案进行。如果在妊娠<34周且不存在宫缩抑制剂使用禁忌的情况下，女性在接受治疗方案期间出现复发性早产，则停止泵注治疗并恢复静脉注射硫酸镁。如果复发性宫缩被抑制，则根据原治疗组重新开始泵注治疗。需要48名女性的样本量才能检测到两组平均分娩时间有2周的差异。分析基于意向性治疗原则。
52名女性接受了特布他林（n = 24）或安慰剂（n = 28）治疗。随机分组时，两组在年龄、种族、产次、既往早产史、孕周和宫颈检查方面相似。总体而言，两组之间的平均分娩时间相差1天（特布他林组为29±22天，安慰剂组为28±23天，P = 0.78）。在妊娠<34周和<37周时的早产率没有差异。新生儿结局相似。
对于疑似早产且治疗成功的女性，使用泵注特布他林进行维持治疗并不能延长孕周。
