目的:评价双胎妊娠阴道孕酮预防早产和不良围产结局的效果。
方法:MEDLINE,EMBASE,LILACS,和CINAHL(从成立到2023年1月31日),Cochrane数据库,谷歌学者,参考书目,和会议记录。
方法:在无症状双胎妊娠妇女中比较阴道孕酮与安慰剂或无治疗的随机对照试验。
方法:根据Cochrane干预措施系统评价手册进行系统评价。主要结果是早产<34孕周。次要结局包括不良围产期结局。计算集合相对风险(RR)和95%置信区间(CI)。我们评估了每项纳入研究的偏倚风险,异质性,出版偏见,以及证据的质量,并进行亚组和敏感性分析。
结果:11项研究(3401名女性和6802名胎儿/婴儿)符合纳入标准。在所有的双胎妊娠中,阴道孕酮和安慰剂或无治疗组在早产<34周的风险上没有显着差异(RR,0.99;95%CI,0.84-1.17;高质量证据),<37周(RR,0.99;95%CI,0.92-1.06;高质量证据),和<28周(RR,1.00;95%CI,0.64-1.55;中等质量证据),和自发性早产<34孕周(RR,0.97;95%CI,0.80-1.18;高质量证据)。阴道孕酮对评估的任何围产期结局均无明显影响。亚组分析显示,没有证据表明阴道孕酮对妊娠34周以下早产的不同影响与绒毛膜相关,概念的类型,自发性早产史,阴道孕酮的每日剂量,和开始治疗时的胎龄。早产<37、<34、<32、<30和<28孕周的频率以及不良围产期结局在阴道孕酮和安慰剂组或未选择的双胎妊娠中没有显着差异(8项研究;3274名妇女和6548名胎儿/婴儿)。在经阴道超声检查宫颈长度<30mm的双胎妊娠中(6项研究;306名妇女和612名胎儿/婴儿),阴道孕酮与<28至<32孕周的早产风险显着降低相关(RRs,0.48-0.65;中等至高质量证据),新生儿死亡(RR,0.32;95%CI,0.11-0.92;中等质量证据),出生体重<1500克(RR,0.60;95%CI,0.39-0.88;高质量证据)。阴道孕酮显着降低早产发生在<28至<34孕周的风险(RRs,0.41-0.68),新生儿复合发病率和死亡率(RR,0.59;95%,0.33-0.98),出生体重<1500克(RR,0.55;95%,0.33-0.94)在经阴道超声检查宫颈长度≤25mm的双胎妊娠中(6项研究;95名妇女和190名胎儿/婴儿)。所有这些结果的证据质量都是中等的。
结论:阴道孕酮不能预防早产,它也不能改善未选择的双胎妊娠的围产期结局,但它似乎可以降低胎龄早期早产的风险,以及超声检查宫颈短的双胎妊娠的新生儿发病率和死亡率。然而,在推荐这一部分患者进行干预之前,还需要更多的证据..
To evaluate the efficacy of vaginal progesterone for the prevention of preterm birth and adverse perinatal outcomes in twin gestations.
MEDLINE, Embase, LILACS, and CINAHL (from their inception to January 31, 2023), Cochrane databases, Google Scholar, bibliographies, and conference proceedings.
Randomized controlled trials that compared vaginal progesterone to placebo or no treatment in asymptomatic women with a twin gestation.
The systematic
review was conducted according to the Cochrane Handbook for Systematic Reviews of Interventions. The primary outcome was preterm birth <34 weeks of gestation. Secondary outcomes included adverse perinatal outcomes. Pooled relative risks with 95% confidence intervals were calculated. We assessed the risk of bias in each included study, heterogeneity, publication bias, and quality of evidence, and performed subgroup and sensitivity analyses.
Eleven studies (3401 women and 6802 fetuses/infants) fulfilled the inclusion criteria. Among all twin gestations, there were no significant differences between the vaginal progesterone and placebo or no treatment groups in the risk of preterm birth <34 weeks (relative risk, 0.99; 95% confidence interval, 0.84-1.17; high-quality evidence), <37 weeks (relative risk, 0.99; 95% confidence interval, 0.92-1.06; high-quality evidence), and <28 weeks (relative risk, 1.00; 95% confidence interval, 0.64-1.55; moderate-quality evidence), and spontaneous preterm birth <34 weeks of gestation (relative risk, 0.97; 95% confidence interval, 0.80-1.18; high-quality evidence). Vaginal progesterone had no significant effect on any of the perinatal outcomes evaluated. Subgroup analyses showed that there was no evidence of a different effect of vaginal progesterone on preterm birth <34 weeks of gestation related to chorionicity, type of conception, history of spontaneous preterm birth, daily dose of vaginal progesterone, and gestational age at initiation of treatment. The frequencies of preterm birth <37, <34, <32, <30, and <28 weeks of gestation and adverse perinatal outcomes did not significantly differ between the vaginal progesterone and placebo or no treatment groups in unselected twin gestations (8 studies; 3274 women and 6548 fetuses/infants). Among twin gestations with a transvaginal sonographic cervical length <30 mm (6 studies; 306 women and 612 fetuses/infants), vaginal progesterone was associated with a significant decrease in the risk of preterm birth occurring at <28 to <32 gestational weeks (relative risks, 0.48-0.65; moderate- to high-quality evidence), neonatal death (relative risk, 0.32; 95% confidence interval, 0.11-0.92; moderate-quality evidence), and birthweight <1500 g (relative risk, 0.60; 95% confidence interval, 0.39-0.88; high-quality evidence). Vaginal progesterone significantly reduced the risk of preterm birth occurring at <28 to <34 gestational weeks (relative risks, 0.41-0.68), composite neonatal morbidity and mortality (relative risk, 0.59; 95% confidence interval, 0.33-0.98), and birthweight <1500 g (relative risk, 0.55; 95% confidence interval, 0.33-0.94) in twin gestations with a transvaginal sonographic cervical length ≤25 mm (6 studies; 95 women and 190 fetuses/infants). The quality of evidence was moderate for all these outcomes.
Vaginal progesterone does not prevent preterm birth, nor does it improve perinatal outcomes in unselected twin gestations, but it appears to reduce the risk of preterm birth occurring at early gestational ages and of neonatal morbidity and mortality in twin gestations with a sonographic short cervix. However, more evidence is needed before recommending this intervention to this subset of patients.