UNASSIGNED: To investigate the effectiveness of daily 400 mg VMP for the prolongation of pregnancy after APTL.
UNASSIGNED: This randomized clinical trial was conducted between December 19, 2018, and February 27, 2023, in 3 university-affiliated medical centers in Israel. Participants included women with singleton and twin pregnancies after APTL following tocolysis at 24 weeks 0 days to 34 weeks 0 days\' gestation. Women with a history of preterm delivery or asymptomatic cervical shortening in the current pregnancy were excluded.
UNASSIGNED: Participants were randomly allocated to receive VMP 200 mg twice a day or no treatment until 36 weeks 6 days\' gestation.
UNASSIGNED: The primary end points were mean number of days from study enrollment to delivery and the rate of SPTD prior to 37 weeks\' gestation.
UNASSIGNED: A total of 129 participants were enrolled (65 in the VMP group and 64 in the no-treatment group). Mean (SD) age was 27.6 (5.1) years. Between the VMP and no-treatment groups, there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) and the rate of SPTD (16 [25%] vs 19 [30%]; relative risk, 0.8; 95% CI, 0.5-1.5; P = .52). In twin pregnancies, including 12 and 15 pairs in the VMP and no-treatment groups, respectively, VMP prolonged pregnancy (mean [SD], 43.7 [18.1] vs 26.1 [15.2] days; P = .02), postponed the delivery week (36.5 [1.4] vs 34.7 [2.2] weeks; P = .01), shortened the length of stay in the neonatal intensive care unit (4.9 [10.6] vs 13.2 [18.5] days; P = .03) and overall hospital stay (8.3 [9.6] vs 15.1 [17.2] days; P = .03), and was associated with a higher birth weight (2444 [528] vs 2018 [430] g; P = .01).
UNASSIGNED: These findings show that VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. However, VMP demonstrated beneficial effects in twin pregnancies, warranting further investigation.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02430233.
■研究每日400mgVMP对APTL后延长妊娠的有效性。
■这项随机临床试验于2018年12月19日至2023年2月27日在以色列3所大学附属医疗中心进行。参与者包括妊娠24周0天至34周0天分娩后APTL单胎和双胎妊娠的妇女。排除在当前妊娠中有早产或无症状宫颈缩短史的妇女。
■参与者被随机分配接受VMP200mg,每天两次或不接受治疗,直到妊娠36周6天。
主要终点为从研究入组到分娩的平均天数以及妊娠37周前的SPTD发生率。
■共纳入129名参与者(VMP组65名,无治疗组64名)。平均(SD)年龄为27.6(5.1)岁。在VMP组和不治疗组之间,妊娠延长没有差异(平均值[SD],40.0[17.8]对37.4[20.3]天;P=.44)和SPTD率(16[25%]对19[30%];相对风险,0.8;95%CI,0.5-1.5;P=.52)。在双胞胎怀孕中,包括12和15对VMP和无治疗组,分别,VMP延长妊娠(平均[SD],43.7[18.1]对26.1[15.2]天;P=.02),推迟交货周(36.5[1.4]对34.7[2.2]周;P=0.01),缩短了新生儿重症监护病房的住院时间(4.9[10.6]对13.2[18.5]天;P=0.03)和总住院时间(8.3[9.6]对15.1[17.2]天;P=0.03),并与较高的出生体重相关(2444[528]vs2018[430]g;P=0.01)。
■这些发现表明,在APTL后每天两次以200mg的剂量给予VMP并不是延长妊娠或预防SPTD的有效治疗方法。然而,VMP在双胎妊娠中表现出有益作用,保证进一步调查。
■ClinicalTrials.gov标识符:NCT02430233。