Pub Date : 2024-09-12DOI: 10.1016/j.ajogmf.2024.101492
Ioannis Mitrogiannis, Christos Chatzakis, Alexandros Sotiriadis, Stylianos Makrydimas, Alexandros Katrachouras, Athina Efthymiou, George Makrydimas
<p><strong>Objective: </strong>The aim of this study was to assess the effect of elective fetal reduction in uncomplicated twin pregnancies on maternal-fetal outcomes, compared to ongoing twin pregnancies.</p><p><strong>Data sources: </strong>PubMed, Scopus (until December 2023), and references of retrieved articles.</p><p><strong>Study appraisal and synthesis methods: </strong>Quality assessment of observational studies was conducted using the ROBINS-I tool. The overall quality of evidence was evaluated per GRADE. A quantitative analysis was performed for electively reduced dichorionic twins. Primary outcome was preterm birth. Secondary outcomes were gestational age at delivery, stillbirth and neonatal intensive care unit, gestational diabetes mellitus, pre-eclampsia, and pregnancy loss < 24 weeks of gestation. Summary odds ratio (ORs) with 95% confidence intervals (CIs) were calculated, and random-effects models were used for data synthesis.</p><p><strong>Results: </strong>The initial electronic search yielded 745 studies; 175 studies were further identified from reference citations. Five articles included appropriate data and were finally included in the meta-analysis. All studies were evaluated as "moderate risk of bias". Those five studies reported on dichorionic twins. Elective reduction in dichorionic twins reduces the risk for preterm birth <37 weeks (4 studies; n=1577; OR 0.14, 95% CI 0.09-0.22, moderate-quality evidence), <34 weeks (3 studies; n=1335; OR 0.22, 95% CI 0.07-0.69; low-quality evidence), <32 weeks (3 studies; n=1335; OR 0.31, 95% CI, 0.11-0.88; low-quality evidence), gestational diabetes (3 studies; n= 1410; OR 0.57, 95% CI 0.33-0.97, low-quality evidence), pregnancy-associated hypertensive disorders (2 studies; n=581; OR 0.29, 95% CI 0.10-0.83; low-quality evidence), birthweight <10<sup>th</sup> centile (2 studies; n=1163; OR 0.27, 95% CI 0.17-0.43; moderate-quality evidence), birthweight< 5<sup>th</sup> centile (2 studies; n=1163; OR 0.31, 95% CI 0.19-0.50; low-quality evidence) and increases gestational age at delivery {four studies; n= 1362; MD 2.93 weeks, 95% CI 2.08-3.77; moderate-quality evidence}. The risk for stillbirth (2 studies; n= 1311; OR 1.63, 95% CI 0.43-6.21; very low-quality evidence) or pregnancy loss< 24 weeks (3 studies; n=1436; OR 1.20, 95% CI 0.55-2.58; very low-quality evidence) were not statistically significant different.</p><p><strong>Conclusions: </strong>Compared to ongoing dichorionic twin pregnancies, dichorionic pregnancies that undergo elective selective fetal reduction are associated with lower incidences of preterm birth < 37 weeks, <34 weeks, <32 weeks, birthweight <10<sup>th</sup> centile and <5<sup>th</sup> centile, gestational diabetes, hypertensive disorders of pregnancy, and later gestational age at delivery by almost 3 weeks. These associations were often based on very low quality of evidence; so these results should be interpreted with caution and further studies should be conducte
研究目的本研究旨在评估无并发症双胎妊娠中选择性减胎术对母胎结局的影响，并与持续性双胎妊娠进行比较：数据来源：PubMed、Scopus（截至 2023 年 12 月）和检索到的文章参考文献：采用 ROBINS-I 工具对观察性研究进行质量评估。证据的总体质量按照 GRADE 进行评估。对选择性减胎的二绒毛膜双胎进行了定量分析。主要结果是早产。次要结局是分娩时的胎龄、死产和新生儿重症监护室、妊娠糖尿病、先兆子痫和妊娠期<24周的妊娠损失。研究人员计算了汇总的几率比（ORs）及 95% 的置信区间（CIs），并使用随机效应模型进行数据综合：最初的电子检索产生了 745 项研究；从参考引文中进一步确定了 175 项研究。有 5 篇文章包含了适当的数据，最终被纳入荟萃分析。所有研究均被评估为 "中度偏倚风险"。这五篇研究报告的对象是二雌双胞胎。对二绒毛膜双胎进行选择性减胎术可降低早产th百分位数（2项研究；n=1163；OR 0.27，95% CI 0.17-0.43；中等质量证据）、出生体重<5百分位数（2项研究；n=1163；OR 0.31，95% CI 0.19-0.50；低质量证据）的风险，并增加分娩时的胎龄{4项研究；n=1362；MD 2.93周，95% CI 2.08-3.77；中等质量证据}。死胎（2 项研究；n= 1311；OR 1.63，95% CI 0.43-6.21；极低质量证据）或妊娠损失< 24 周（3 项研究；n= 1436；OR 1.20，95% CI 0.55-2.58；极低质量证据）的风险在统计学上没有显著差异：结论：与二绒毛膜双胎妊娠相比，接受选择性胎儿减胎术的二绒毛膜双胎妊娠的早产<37周、妊娠期糖尿病、妊娠期高血压疾病的发生率较低，胎龄推迟近3周。这些关联往往基于质量很低的证据；因此，在解释这些结果时应谨慎，并应开展进一步的研究。
{"title":"Selective Fetal Reduction of Uncomplicated Dichorionic Twins on Parental Request Versus Ongoing Twins and Pregnancy Outcomes: A Systematic Review and Meta-analysis.","authors":"Ioannis Mitrogiannis, Christos Chatzakis, Alexandros Sotiriadis, Stylianos Makrydimas, Alexandros Katrachouras, Athina Efthymiou, George Makrydimas","doi":"10.1016/j.ajogmf.2024.101492","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101492","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to assess the effect of elective fetal reduction in uncomplicated twin pregnancies on maternal-fetal outcomes, compared to ongoing twin pregnancies.</p><p><strong>Data sources: </strong>PubMed, Scopus (until December 2023), and references of retrieved articles.</p><p><strong>Study appraisal and synthesis methods: </strong>Quality assessment of observational studies was conducted using the ROBINS-I tool. The overall quality of evidence was evaluated per GRADE. A quantitative analysis was performed for electively reduced dichorionic twins. Primary outcome was preterm birth. Secondary outcomes were gestational age at delivery, stillbirth and neonatal intensive care unit, gestational diabetes mellitus, pre-eclampsia, and pregnancy loss < 24 weeks of gestation. Summary odds ratio (ORs) with 95% confidence intervals (CIs) were calculated, and random-effects models were used for data synthesis.</p><p><strong>Results: </strong>The initial electronic search yielded 745 studies; 175 studies were further identified from reference citations. Five articles included appropriate data and were finally included in the meta-analysis. All studies were evaluated as \"moderate risk of bias\". Those five studies reported on dichorionic twins. Elective reduction in dichorionic twins reduces the risk for preterm birth <37 weeks (4 studies; n=1577; OR 0.14, 95% CI 0.09-0.22, moderate-quality evidence), <34 weeks (3 studies; n=1335; OR 0.22, 95% CI 0.07-0.69; low-quality evidence), <32 weeks (3 studies; n=1335; OR 0.31, 95% CI, 0.11-0.88; low-quality evidence), gestational diabetes (3 studies; n= 1410; OR 0.57, 95% CI 0.33-0.97, low-quality evidence), pregnancy-associated hypertensive disorders (2 studies; n=581; OR 0.29, 95% CI 0.10-0.83; low-quality evidence), birthweight <10<sup>th</sup> centile (2 studies; n=1163; OR 0.27, 95% CI 0.17-0.43; moderate-quality evidence), birthweight< 5<sup>th</sup> centile (2 studies; n=1163; OR 0.31, 95% CI 0.19-0.50; low-quality evidence) and increases gestational age at delivery {four studies; n= 1362; MD 2.93 weeks, 95% CI 2.08-3.77; moderate-quality evidence}. The risk for stillbirth (2 studies; n= 1311; OR 1.63, 95% CI 0.43-6.21; very low-quality evidence) or pregnancy loss< 24 weeks (3 studies; n=1436; OR 1.20, 95% CI 0.55-2.58; very low-quality evidence) were not statistically significant different.</p><p><strong>Conclusions: </strong>Compared to ongoing dichorionic twin pregnancies, dichorionic pregnancies that undergo elective selective fetal reduction are associated with lower incidences of preterm birth < 37 weeks, <34 weeks, <32 weeks, birthweight <10<sup>th</sup> centile and <5<sup>th</sup> centile, gestational diabetes, hypertensive disorders of pregnancy, and later gestational age at delivery by almost 3 weeks. These associations were often based on very low quality of evidence; so these results should be interpreted with caution and further studies should be conducte","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1016/j.ajogmf.2024.101485
Arthurine K Zakama, Erinma P Ukoha, Maura Jones Pullins, Edward Miller, Lisa D Levine, Abike James
{"title":"Beyond race: embracing epistemic justice in addressing antiblack racism as a cardiovascular risk factor in pregnancy.","authors":"Arthurine K Zakama, Erinma P Ukoha, Maura Jones Pullins, Edward Miller, Lisa D Levine, Abike James","doi":"10.1016/j.ajogmf.2024.101485","DOIUrl":"10.1016/j.ajogmf.2024.101485","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1016/j.ajogmf.2024.101489
Kirat Sandhu, Cara Dolin, Adina R Kern-Goldberger
{"title":"Utilizing Perinatal Patient Navigation to Address Self-Identified Social Determinants of Health in Pregnancy.","authors":"Kirat Sandhu, Cara Dolin, Adina R Kern-Goldberger","doi":"10.1016/j.ajogmf.2024.101489","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101489","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1016/j.ajogmf.2024.101483
Kandice A Kapinos, Molly Waymouth, Kristin N Ray, Jill R Demirci, Ateev Mehrotra, Kortney James, Gabriela Alvarado, Khadesia Howell, Maria DeYoreo, Lori Uscher-Pines
{"title":"Telelactation Use Patterns among a Racially and Ethnically Diverse Sample of U.S. Parents: Secondary Analysis of a Randomized Controlled Trial: Telelactation Use Patterns among a Racially and Ethnically Diverse Sample.","authors":"Kandice A Kapinos, Molly Waymouth, Kristin N Ray, Jill R Demirci, Ateev Mehrotra, Kortney James, Gabriela Alvarado, Khadesia Howell, Maria DeYoreo, Lori Uscher-Pines","doi":"10.1016/j.ajogmf.2024.101483","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101483","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1016/j.ajogmf.2024.101490
Kate Swanson, Mary E Norton, Sara L Ackerman, Ms Billie R Lianoglou, Nuriye N Sahin-Hodoglugil, Teresa N Sparks
{"title":"Patient Understanding of Prenatal Exome Sequencing.","authors":"Kate Swanson, Mary E Norton, Sara L Ackerman, Ms Billie R Lianoglou, Nuriye N Sahin-Hodoglugil, Teresa N Sparks","doi":"10.1016/j.ajogmf.2024.101490","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101490","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1016/j.ajogmf.2024.101484
{"title":"Exploring whether measuring gender in pregnancy research results in participant loss","authors":"","doi":"10.1016/j.ajogmf.2024.101484","DOIUrl":"10.1016/j.ajogmf.2024.101484","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.ajogmf.2024.101480
Vincenzo Berghella, Moti Gulersen
{"title":"We thank the authors for their interest. We agree with their proposed additional method to measure a transvaginal cervical length in the setting of a lower uterine segment contraction.","authors":"Vincenzo Berghella, Moti Gulersen","doi":"10.1016/j.ajogmf.2024.101480","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101480","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.1016/j.ajogmf.2024.101482
Neema Pithia, Ophelia Yin, Lisa A Coscia, Serban Constantinescu, Michael J Moritz, Yalda Afshar
{"title":"Differences in neonatal sepsis among immunosuppression regimens in pregnancies of transplant recipients: Neonatal sepsis differs among immunosuppression regimens in pregnancies of transplant recipients.","authors":"Neema Pithia, Ophelia Yin, Lisa A Coscia, Serban Constantinescu, Michael J Moritz, Yalda Afshar","doi":"10.1016/j.ajogmf.2024.101482","DOIUrl":"https://doi.org/10.1016/j.ajogmf.2024.101482","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142297346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.ajogmf.2024.101436
Background
Induction of labor (IOL) with mechanical methods or pharmacological agents is used in about 20% to 30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix with adequate samples.
Objective
To compare the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix.
Study Design
This is a parallel, open-label randomized controlled trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score <6) scheduled for IOL were eligible. A total of 1860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10 mg) or a 60 cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The trial was registered with the China trial registry (CTR2000038435).
Results
The vaginal birth rates were 72.8% (677/930) vs 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% confidence interval [CI] 0.98-1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs 8.2%, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs 3.8%, aRR 1.21, 95% CI 0.78-1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs 0.2%, aRR 5.39, 95% CI 1.22-23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs 97.0%, aRR 0.93, 95% CI 0.88-0.99).
Conclusions
In term pregnant women with an unfavorable cervix, IOL with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.
背景：约有20%-30%的孕妇使用机械方法或药物引产。我们专门比较了地诺前列酮与经宫颈福来导管对宫颈不佳且样本充足的足月孕妇引产的有效性和安全性：比较地诺前列酮与经宫颈福来导管用于宫颈不利的足月孕妇引产的有效性和安全性：这是一项平行、开放标签的随机对照试验，于2019年10月至2022年7月期间在中国上海的两家妇产中心进行。研究对象为足月头位单胎妊娠且宫颈不良（Bishop评分小于6分）、计划引产的女性。1,860名妇女被随机分配到使用地诺前列酮阴道插入物（10毫克）或60cc Foley导尿管进行宫颈成熟，最长24小时。主要结果是阴道分娩率和阴道分娩时间。次要结果包括分娩时间、产妇和新生儿发病率。分析从意向治疗的角度进行。该试验已在中国试验注册中心注册（CTR2000038435）：阴道分娩率分别为 72.8%（677/930）vs 69.9%（650/930）（aRR 1.04，95% CI 0.98 至 1.10，风险差异：0.03）。两组的阴道分娩时间无明显差异（亚分布危险比 1.11，95% CI 0.99-1.24）。阴道地诺前列酮更有可能并发胎心率改变的高刺激（5.8% vs. 2.8%，aRR 2.09，95% CI 1.32-3.31）和胎盘早剥（0.9% vs. 0.1%，aRR：8.04，95% CI 1.01-64.15），而 Foley 导管更有可能并发胎心率改变的高刺激。15），而 Foley 导管更可能并发疑似产内感染（5.1% 对 8.2%，aRR：0.62，95% CI 0.44-0.88）和产后感染（1.4% 对 3.7%，aRR：0.38，95% CI 0.20-0.72）。两组新生儿不良预后的综合结果无显著差异（4.5% 对 3.8%，aRR 1.21，95% CI 0.78 至 1.88），而地诺前列酮组新生儿窒息发生率更高（1.2% 对 0.2%，aRR 5.39，95% CI 1.22 至 23.92）。在一项亚组分析中，阴道地诺前列酮可使多产妇的阴道分娩率略有下降（90.6% 对 97.0%，aRR 0.93，95% CI 0.88 对 0.99）：对于宫颈不佳的足月孕妇，使用阴道地诺前列酮或福来导管引产的效果相似。使用 Foley 导管对新生儿更安全，但可能会增加产妇感染的风险。此外，多产妇应首选 Foley 导管。
{"title":"Vaginal dinoprostone vs Foley catheter for induction of labor at term with an unfavorable cervix: an open-label randomized controlled trial","authors":"","doi":"10.1016/j.ajogmf.2024.101436","DOIUrl":"10.1016/j.ajogmf.2024.101436","url":null,"abstract":"<div><h3>Background</h3><p>Induction of labor (IOL) with mechanical methods or pharmacological agents is used in about 20% to 30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix with adequate samples.</p></div><div><h3>Objective</h3><p>To compare the effectiveness and safety of dinoprostone vs transcervical Foley catheter for IOL in term pregnant women with an unfavorable cervix.</p></div><div><h3>Study Design</h3><p>This is a parallel, open-label randomized controlled trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score <6) scheduled for IOL were eligible. A total of 1860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10 mg) or a 60 cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The trial was registered with the China trial registry (CTR2000038435).</p></div><div><h3>Results</h3><p>The vaginal birth rates were 72.8% (677/930) vs 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% confidence interval [CI] 0.98-1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs 8.2%, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs 3.8%, aRR 1.21, 95% CI 0.78-1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs 0.2%, aRR 5.39, 95% CI 1.22-23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs 97.0%, aRR 0.93, 95% CI 0.88-0.99).</p></div><div><h3>Conclusions</h3><p>In term pregnant women with an unfavorable cervix, IOL with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.</p></div>","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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