PDF(Pubmed)
Abstract：
UNASSIGNED: Women with arrested preterm labor (APTL) are at very high risk for spontaneous preterm delivery (SPTD), the leading cause of neonatal mortality and morbidity. To date, no maintenance therapy has been found to be effective for pregnancy prolongation. A few clinical trials with considerable methodological limitations have demonstrated some efficacy for 400 mg vaginal micronized progesterone (VMP) in women with APTL.
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.
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.
摘要：
■早产（APTL）的妇女自发早产（SPTD）的风险很高，新生儿死亡和发病的主要原因。迄今为止,没有发现维持治疗对延长妊娠有效。一些具有相当大的方法学局限性的临床试验已经证明了400mg阴道微粉化孕酮（VMP）在APTL女性中的某些功效。
■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。
■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。
