Abstract：
BACKGROUND: To compare neonatal, obstetrical, and maternal outcomes associated with outpatient versus inpatient management of pregnancies with preterm prelabor rupture of membranes (PPROM).
METHODS: A search of MEDLINE, EMBASE, the Cochrane Database and Central Register from January 1, 1990 to July 31, 2023 identified randomized controlled trials (RCTs) and cohort studies comparing outpatient with inpatient management for pregnant persons diagnosed with PPROM before 37 weeks\' gestation. No language restriction was applied. We applied a random effects model for meta-analysis. Trustworthiness was assessed using recently published guidance and Risk of bias using the RoB 2.0 tool for RCTs and ROBINS-I tool for cohort studies. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the certainty of evidence (COE). Outcomes of interest included perinatal mortality, neonatal morbidities, latency and gestational age at delivery, and maternal morbidities. RCTs and cohort studies were analyzed separately. This study was registered in the International Prospective Register of Systematic Reviewsr: CRD42022295275.
RESULTS: From 2825 records, two RCTs and 10 cohort studies involving 1876 patients were included in the review and meta-analysis. Outpatient management protocols varied but generally included brief initial hospitalization, strict eligibility criteria, and surveillance with laboratory and ultrasound investigations. Outpatient management showed lower rates of neonatal respiratory distress syndrome (cohort: RR 0.63 [0.52-0.77, very low COE]), longer latency to delivery (RCT: MD 7.43 days [1.14-13.72 days, moderate COE], cohort: MD 8.78 days [2.29-15.26 days, low COE]), higher gestational age at birth (cohort: MD 7.70 days [2.02-13.38 days, low COE]), lower rates of Apgar scores <7 at 5 min of life (cohort: RR 0.66 [0.50-0.89, very low COE]), and lower rates of histological chorioamnionitis (cohort: RR 0.74 [0.62-0.89, low COE]) without increased risks of adverse neonatal, obstetrical, or maternal outcomes.
CONCLUSIONS: Meta-analysis of data from RCTs and cohort studies with very low-to-moderate certainty of evidence indicates that further high-quality research is needed to evaluate the safety and potential benefits of outpatient management for selected PPROM cases, given the moderate-to-high risk of bias in the included studies.
METHODS: A search of MEDLINE, EMBASE, the Cochrane Database and Central Register from January 1, 1990 to July 31, 2023 identified randomized controlled trials (RCTs) and cohort studies comparing outpatient with inpatient management for pregnant persons diagnosed with PPROM before 37 weeks\' gestation. No language restriction was applied. We applied a random effects model for meta-analysis. Trustworthiness was assessed using recently published guidance and Risk of bias using the RoB 2.0 tool for RCTs and ROBINS-I tool for cohort studies. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the certainty of evidence (COE). Outcomes of interest included perinatal mortality, neonatal morbidities, latency and gestational age at delivery, and maternal morbidities. RCTs and cohort studies were analyzed separately. This study was registered in the International Prospective Register of Systematic Reviewsr: CRD42022295275.
RESULTS: From 2825 records, two RCTs and 10 cohort studies involving 1876 patients were included in the review and meta-analysis. Outpatient management protocols varied but generally included brief initial hospitalization, strict eligibility criteria, and surveillance with laboratory and ultrasound investigations. Outpatient management showed lower rates of neonatal respiratory distress syndrome (cohort: RR 0.63 [0.52-0.77, very low COE]), longer latency to delivery (RCT: MD 7.43 days [1.14-13.72 days, moderate COE], cohort: MD 8.78 days [2.29-15.26 days, low COE]), higher gestational age at birth (cohort: MD 7.70 days [2.02-13.38 days, low COE]), lower rates of Apgar scores <7 at 5 min of life (cohort: RR 0.66 [0.50-0.89, very low COE]), and lower rates of histological chorioamnionitis (cohort: RR 0.74 [0.62-0.89, low COE]) without increased risks of adverse neonatal, obstetrical, or maternal outcomes.
CONCLUSIONS: Meta-analysis of data from RCTs and cohort studies with very low-to-moderate certainty of evidence indicates that further high-quality research is needed to evaluate the safety and potential benefits of outpatient management for selected PPROM cases, given the moderate-to-high risk of bias in the included studies.
摘要：
背景：为了比较新生儿，产科,以及与门诊和住院的早产胎膜破裂（PPROM）妊娠管理相关的产妇结局。
方法：搜索MEDLINE，EMBASE,1990年1月1日至2023年7月31日的Cochrane数据库和中央登记册确定了随机对照试验(RCT)和队列研究,比较了妊娠37周前诊断为PPROM的孕妇的门诊和住院管理.未应用语言限制。我们应用随机效应模型进行荟萃分析。使用最近发布的指南和偏倚风险评估可信性，使用RCT的RoB2.0工具和队列研究的ROBINS-I工具。建议的分级，评估,发展,和评估(等级)方法用于评估证据的确定性(COE)。感兴趣的结果包括围产期死亡率，新生儿发病率,分娩时的潜伏期和胎龄，和产妇的发病率。RCT和队列研究分别进行分析。本研究已在国际前瞻性系统审查注册簿中注册：CRD42022295275。
结果：来自2825条记录，本综述和荟萃分析纳入了2项RCT和10项队列研究,涉及1,876例患者.门诊管理方案各不相同，但通常包括短暂的初次住院，严格的资格标准，以及实验室和超声检查的监测。门诊管理显示新生儿呼吸窘迫综合征的发生率较低（队列：RR0.63[0.52-0.77，COE非常低]），交货延迟更长(RCT：MD7.43天[1.14-13.72天，中等COE]，队列：MD8.78天[2.29-15.26天，低COE])，出生胎龄较高(队列：MD7.70天[2.02-13.38天，低COE])，生命5分钟时Apgar评分<7的发生率较低（队列：RR0.66[0.50-0.89，COE非常低]），和较低的组织学绒毛膜羊膜炎的发生率（队列：RR0.74[0.62-0.89，低COE]）没有增加不良新生儿的风险，产科,或产妇结局。
结论：对来自随机对照试验和队列研究的数据进行荟萃分析，证据的确定性非常低至中等，表明需要进一步的高质量研究来评估门诊管理的安全性和潜在益处对于选定的PPROM病例，考虑到纳入研究中偏倚的中到高风险。
方法：搜索MEDLINE，EMBASE,1990年1月1日至2023年7月31日的Cochrane数据库和中央登记册确定了随机对照试验(RCT)和队列研究,比较了妊娠37周前诊断为PPROM的孕妇的门诊和住院管理.未应用语言限制。我们应用随机效应模型进行荟萃分析。使用最近发布的指南和偏倚风险评估可信性，使用RCT的RoB2.0工具和队列研究的ROBINS-I工具。建议的分级，评估,发展,和评估(等级)方法用于评估证据的确定性(COE)。感兴趣的结果包括围产期死亡率，新生儿发病率,分娩时的潜伏期和胎龄，和产妇的发病率。RCT和队列研究分别进行分析。本研究已在国际前瞻性系统审查注册簿中注册：CRD42022295275。
结果：来自2825条记录，本综述和荟萃分析纳入了2项RCT和10项队列研究,涉及1,876例患者.门诊管理方案各不相同，但通常包括短暂的初次住院，严格的资格标准，以及实验室和超声检查的监测。门诊管理显示新生儿呼吸窘迫综合征的发生率较低（队列：RR0.63[0.52-0.77，COE非常低]），交货延迟更长(RCT：MD7.43天[1.14-13.72天，中等COE]，队列：MD8.78天[2.29-15.26天，低COE])，出生胎龄较高(队列：MD7.70天[2.02-13.38天，低COE])，生命5分钟时Apgar评分<7的发生率较低（队列：RR0.66[0.50-0.89，COE非常低]），和较低的组织学绒毛膜羊膜炎的发生率（队列：RR0.74[0.62-0.89，低COE]）没有增加不良新生儿的风险，产科,或产妇结局。
结论：对来自随机对照试验和队列研究的数据进行荟萃分析，证据的确定性非常低至中等，表明需要进一步的高质量研究来评估门诊管理的安全性和潜在益处对于选定的PPROM病例，考虑到纳入研究中偏倚的中到高风险。
