Pub Date : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101578
William W. Hurd MD
{"title":"Myometrial shortening stimulates contractility: a biomechanical hypothesis for labor onset and progression","authors":"William W. Hurd MD","doi":"10.1016/j.ajogmf.2024.101578","DOIUrl":"10.1016/j.ajogmf.2024.101578","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101578"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872929","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101540
Alissa Paudel MD, Rachel A. Tinius PhD, Kimberly B. Fortner MD, Linda M. Szymanski MD, PhD, Nikki B. Zite MPH, MD, Jill M. Maples PhD
{"title":"Physician recommendations for physical activity and lifestyle changes in pregnancies with fetal growth restriction: a survey","authors":"Alissa Paudel MD, Rachel A. Tinius PhD, Kimberly B. Fortner MD, Linda M. Szymanski MD, PhD, Nikki B. Zite MPH, MD, Jill M. Maples PhD","doi":"10.1016/j.ajogmf.2024.101540","DOIUrl":"10.1016/j.ajogmf.2024.101540","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101540"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591657","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101549
A. Dhanya Mackeen MD, MPH , Maranda V. Sullivan DO , Whitney Bender MD , Daniele Di Mascio MD , Vincenzo Berghella MD
<div><div>The following review focuses on routine postoperative care after cesarean delivery (CD), including specific Enhanced Recovery After Cesarean recommendations as well as important postpartum counseling points. Following CD, there is insufficient evidence to support administration of prophylactic multi-dose antibiotics to all patients. Additional antibiotic doses are indicated for the following scenarios: patients with obesity who did not receive preoperative azithromycin, CD lasting ≥4 hours since prophylactic dose, blood loss >1500 mL, or those with an intra-amniotic infection. An oxytocin infusion for prevention of postpartum hemorrhage should be continued post-CD. While initial measures to prevent postoperative pain occur in the intraoperative period, with the consideration of 1 g intravenous (IV) acetaminophen and IV or intramuscular nonsteroidal anti-inflammatory medications (eg, 30 mg IV ketorolac), the focus postoperatively continues with this multimodal approach with scheduled acetaminophen per os (PO, 650 mg every 6 hours) and nonsteroidal agents (ketorolac 30 mg IV every 6 hours for 4 doses followed by ibuprofen 600 mg PO every 6 hours) being recommended. Short-acting opioids should be reserved for breakthrough pain. Low-risk patients should receive mechanical thromboprophylaxis until ambulation with chemoprophylaxis being reserved for patients with additional risk factors. When an indwelling bladder catheter was placed intraoperatively for scheduled CD, it should be removed immediately postoperatively. Chewing gum to aid in return of bowel function and early oral intake of solid food can occur immediately after CD and within 2 hours, respectively. For prevention of postoperative nausea and vomiting, administration of 5HT<sub>3</sub> antagonists with the addition of either a dopamine antagonist or a corticosteroid is recommended based on noncesarean data. Early ambulation after CD starting 4 hours postoperatively is encouraged and should be incentivized by pedometer. For patients that receive a dressing over the CD skin incision, limited evidence supports leaving it in place for 48 hours. Adjunct nonpharmacologic interventions for postoperative recovery discussed in this review are acupressure, acupuncture, aromatherapy, coffee, ginger, massage, reiki, and transcutaneous electrical nerve stimulation. In the low-risk patient, hospital discharge may occur as early as 24 to 28 hours if close (ie, 1–2 days) outpatient neonatal follow-up is available due to the potential for neonatal jaundice; otherwise, patients should be discharged at 48 to 72 hours postoperatively. Upon discharge, the multimodal pain control recommendations of acetaminophen and ibuprofen should be continued. If short-acting opioids are necessary, the prescribing practices should be individualized based upon the inpatient opioid requirements. Other portions of postoperative/postpartum counseling during the inpatient stay include the optimal interpregnancy interv
{"title":"Evidence-based cesarean delivery: postoperative care (part 10)","authors":"A. Dhanya Mackeen MD, MPH , Maranda V. Sullivan DO , Whitney Bender MD , Daniele Di Mascio MD , Vincenzo Berghella MD","doi":"10.1016/j.ajogmf.2024.101549","DOIUrl":"10.1016/j.ajogmf.2024.101549","url":null,"abstract":"<div><div>The following review focuses on routine postoperative care after cesarean delivery (CD), including specific Enhanced Recovery After Cesarean recommendations as well as important postpartum counseling points. Following CD, there is insufficient evidence to support administration of prophylactic multi-dose antibiotics to all patients. Additional antibiotic doses are indicated for the following scenarios: patients with obesity who did not receive preoperative azithromycin, CD lasting ≥4 hours since prophylactic dose, blood loss >1500 mL, or those with an intra-amniotic infection. An oxytocin infusion for prevention of postpartum hemorrhage should be continued post-CD. While initial measures to prevent postoperative pain occur in the intraoperative period, with the consideration of 1 g intravenous (IV) acetaminophen and IV or intramuscular nonsteroidal anti-inflammatory medications (eg, 30 mg IV ketorolac), the focus postoperatively continues with this multimodal approach with scheduled acetaminophen per os (PO, 650 mg every 6 hours) and nonsteroidal agents (ketorolac 30 mg IV every 6 hours for 4 doses followed by ibuprofen 600 mg PO every 6 hours) being recommended. Short-acting opioids should be reserved for breakthrough pain. Low-risk patients should receive mechanical thromboprophylaxis until ambulation with chemoprophylaxis being reserved for patients with additional risk factors. When an indwelling bladder catheter was placed intraoperatively for scheduled CD, it should be removed immediately postoperatively. Chewing gum to aid in return of bowel function and early oral intake of solid food can occur immediately after CD and within 2 hours, respectively. For prevention of postoperative nausea and vomiting, administration of 5HT<sub>3</sub> antagonists with the addition of either a dopamine antagonist or a corticosteroid is recommended based on noncesarean data. Early ambulation after CD starting 4 hours postoperatively is encouraged and should be incentivized by pedometer. For patients that receive a dressing over the CD skin incision, limited evidence supports leaving it in place for 48 hours. Adjunct nonpharmacologic interventions for postoperative recovery discussed in this review are acupressure, acupuncture, aromatherapy, coffee, ginger, massage, reiki, and transcutaneous electrical nerve stimulation. In the low-risk patient, hospital discharge may occur as early as 24 to 28 hours if close (ie, 1–2 days) outpatient neonatal follow-up is available due to the potential for neonatal jaundice; otherwise, patients should be discharged at 48 to 72 hours postoperatively. Upon discharge, the multimodal pain control recommendations of acetaminophen and ibuprofen should be continued. If short-acting opioids are necessary, the prescribing practices should be individualized based upon the inpatient opioid requirements. Other portions of postoperative/postpartum counseling during the inpatient stay include the optimal interpregnancy interv","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101549"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669017","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101514
Vincenzo Berghella MD , Emily S. Miller MD, MPH , Molly Stout MD, MS , Adam K. Lewkowitz MD, MPHS , Terri-Ann Bennett MD , Karin A. Fox MD, MEd , American Journal of Obstetrics & Gynecology MFM Editors
{"title":"How the history of midwifery and obstetrics still affects what you do today in pregnancy care: the American Journal of Obstetrics & Gynecology MFM starts a new “Obstetrical history” series","authors":"Vincenzo Berghella MD , Emily S. Miller MD, MPH , Molly Stout MD, MS , Adam K. Lewkowitz MD, MPHS , Terri-Ann Bennett MD , Karin A. Fox MD, MEd , American Journal of Obstetrics & Gynecology MFM Editors","doi":"10.1016/j.ajogmf.2024.101514","DOIUrl":"10.1016/j.ajogmf.2024.101514","url":null,"abstract":"","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101514"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781393","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101515
Malitha Patabendige MBBS, MD , Daniel L. Rolnik MD, PhD, FRANZCOG , Wentao Li MD, PhD , Andrew D. Weeks MD, FRCOG , Ben W. Mol MD, PhD, FRANZCOG
Induction of labor (IOL) is currently used for one in 10 pregnancies globally. Methods used for induction have shown major changes over time. Medical interventions trace their origins back to ancient civilizations, with evidence suggesting that they began over 5000 years ago in ancient Egypt. During this era, the Egyptians employed natural remedies such as castor oil and date fruits for the IOL. These early practices highlight the rich history and long-standing tradition of using natural substances in medical treatments, laying the foundation for the development of modern obstetric practices. After that, Hippocrates practiced mammary stimulation and mechanical cervical dilatation about 2500 years ago in Greece. Since then, there has been a marked change, especially over the last century, with the development of safer and more effective methods. Mechanical methods were the main method until the early 20th century, which were then substituted by pharmacological methods with more experiments in the mid to late 20th century. Nowadays, effectiveness, safety, cost, and client satisfaction are the main determinants of the methods used. This review summarizes how labor induction practices have evolved from the Egyptian era to the present-day randomized controlled trials and meta-analysis evidence, paying attention to their effectiveness, safety, and future directions.
{"title":"How labor induction methods have evolved throughout history, from the Egyptian era to the present day: evolution, effectiveness, and safety","authors":"Malitha Patabendige MBBS, MD , Daniel L. Rolnik MD, PhD, FRANZCOG , Wentao Li MD, PhD , Andrew D. Weeks MD, FRCOG , Ben W. Mol MD, PhD, FRANZCOG","doi":"10.1016/j.ajogmf.2024.101515","DOIUrl":"10.1016/j.ajogmf.2024.101515","url":null,"abstract":"<div><div>Induction of labor (IOL) is currently used for one in 10 pregnancies globally. Methods used for induction have shown major changes over time. Medical interventions trace their origins back to ancient civilizations, with evidence suggesting that they began over 5000 years ago in ancient Egypt. During this era, the Egyptians employed natural remedies such as castor oil and date fruits for the IOL. These early practices highlight the rich history and long-standing tradition of using natural substances in medical treatments, laying the foundation for the development of modern obstetric practices. After that, Hippocrates practiced mammary stimulation and mechanical cervical dilatation about 2500 years ago in Greece. Since then, there has been a marked change, especially over the last century, with the development of safer and more effective methods. Mechanical methods were the main method until the early 20th century, which were then substituted by pharmacological methods with more experiments in the mid to late 20th century. Nowadays, effectiveness, safety, cost, and client satisfaction are the main determinants of the methods used. This review summarizes how labor induction practices have evolved from the Egyptian era to the present-day randomized controlled trials and meta-analysis evidence, paying attention to their effectiveness, safety, and future directions.</div></div>","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101515"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142509575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101583
Antonio F. Saad MD, MBA , Claudia Pedroza PhD , Rachana Gavara MD , Janesh Gupta MD , Ronald J. Wapner MD , George R. Saade MD
<div><h3>Objectives</h3><div>Dilapan-S is a cervical ripening agent approved by the FDA that has been found to be just as effective as other agents and can be utilized for outpatient ripening. No large-scale studies have been conducted to compare cesarean delivery rates between Dilapan-S and other ripening methods. Our objective was to combine these trials to compare cesarean delivery rates for Dilapan-S with other cervical ripening methods, overall and in sub-groups.</div></div><div><h3>Data Sources</h3><div>The time period for this study was from January 1994 to April 2023. Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov, euclinicaltrialsregister.eu, and Scopus were searched. The study was conducted according to the Preferred Reporting Item for Systematic Reviews guidelines and was registered with PROSPERO (CRD42023423573).</div></div><div><h3>Study Eligibility Criteria</h3><div>This was a systematic review and meta-analysis of individual patient data from randomized controlled trials comparing Dilapan-S to other mechanical or pharmacologic cervical ripening methods for labor induction in singleton gestations. The main outcome measure assessed was the cesarean delivery (CD) rate in comparing Dilapan-S to alternative methods. Secondary maternal outcomes included changes in Bishop score postintervention, vaginal delivery without complications, postpartum hemorrhage, cervical ripening issues, uterine infection, and patient satisfaction. Secondary neonatal outcomes were Apgar score <7 at 5 minutes, arterial cord pH <7.1, meconium presence, NICU admission and length of stay, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, infant infection, and infant death. This study exclusively included randomized controlled trials (RCTs) involving participants who underwent labor induction during the third trimester of a singleton pregnancy. At least one group within these trials received Dilapan-S for the purpose of cervical ripening. Trials were excluded if induction occurred prior to 37 weeks of gestation or if cervical ripening was deemed unnecessary.</div></div><div><h3>Study Appraisal and Synthesis</h3><div>Two reviewers independently selected studies, assessed the risk of bias using the Cochrane Risk of Bias Tool for RCTs, and extracted the data. Prespecified subgroup analysis was performed for parity, body mass index, Bishop score, and gestational age. Pooled odds ratios (ORs) adjusted for maternal age and parity with 95% confidence intervals (CI) were calculated using frequentist and Bayesian approaches.</div></div><div><h3>Results</h3><div>Four RCTs were identified, with 1731 women included (1036 allocated to Dilapan-S; 695 to alternative cervical ripening methods). CD rates were 28% and 30% with Dilapan-S and other methods, respectively. There was no difference in maternal age and parity-adjusted CD rates between Dilapan-S and other methods (OR 1.03, 95% CI 0.8–1.3). Bayesian inference indicated a 95% pro
目的:荒废- s是一种经FDA批准的宫颈成熟剂,已被发现与其他药物一样有效,可用于门诊成熟。目前还没有大规模的研究来比较破旧s和其他成熟方法的剖宫产率。我们的目的是将这些试验结合起来,比较整体和亚组的剖宫产率。数据来源:研究时间为1994年1月至2023年4月。Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov, eucclinicaltrials register。eu和Scopus进行了检索。该研究按照系统评价的首选报告项目指南进行,并在PROSPERO注册(CRD42023423573)。研究资格标准:这是一项系统回顾和荟萃分析,来自随机对照试验的个体患者数据(IPD),比较了破旧- s和其他机械或药物宫颈成熟方法用于单胎妊娠引产。评估的主要结果指标是比较危房- s和其他方法的剖宫产率。产妇的次要结局包括干预后Bishop评分的变化、无并发症的阴道分娩、产后出血、宫颈成熟问题、子宫感染和患者满意度。新生儿的次要结局是Apgar评分研究评估和综合:两位评论者独立选择研究,使用Cochrane随机对照试验的偏倚风险评估工具评估偏倚风险,并提取数据。对胎次、BMI、Bishop评分和胎龄进行预先指定的亚组分析。使用频率和贝叶斯方法计算经母亲年龄和胎次校正后的合并优势比(ORs), 95%置信区间(CI)。结果:确定了4个随机对照试验,纳入了1731名妇女(1036名分配到破旧s;695至其他子宫颈成熟方法)。采用cdd法和其他方法分别为28%和30%。在母亲年龄和胎次调整的CD率方面,危房- s和其他方法没有差异(OR 1.03, 95% CI 0.8-1.3)。贝叶斯推断表明非劣的概率为95%(5%边际),劣于其他方法的概率为4.5%。亚组分析显示,与胎次有显著的相互作用,经危房- s治疗的多产妇女降低剖宫产率的概率为99% (RR 0.61, 95% CrI 0.4-0.9),而未产妇女获益的概率为6% (RR 1.13, 95% CrI 0.97-1.33)。≥4级的疼痛水平在危重s组显著降低(46% vs 62%;或0.5,95% ci 0.40-0.64)。宫颈成熟期间的并发症发生率(子宫张力升高、子宫心动过速、胎心不稳定等)在cst组也较低(19% vs 47%;或0.28,95% ci 0.28-0.37)。据报道,病人满意度较高的是荒废- s。结论:在降低剖宫产率方面,与其他诱导前宫颈催熟剂相比,危房- s至少具有不劣势和略微优势。产次影响疗效,多胎妇女受益最多。
{"title":"Dilapan-S vs standard methods for cervical ripening in term pregnancies: an individual patient data meta-analysis","authors":"Antonio F. Saad MD, MBA , Claudia Pedroza PhD , Rachana Gavara MD , Janesh Gupta MD , Ronald J. Wapner MD , George R. Saade MD","doi":"10.1016/j.ajogmf.2024.101583","DOIUrl":"10.1016/j.ajogmf.2024.101583","url":null,"abstract":"<div><h3>Objectives</h3><div>Dilapan-S is a cervical ripening agent approved by the FDA that has been found to be just as effective as other agents and can be utilized for outpatient ripening. No large-scale studies have been conducted to compare cesarean delivery rates between Dilapan-S and other ripening methods. Our objective was to combine these trials to compare cesarean delivery rates for Dilapan-S with other cervical ripening methods, overall and in sub-groups.</div></div><div><h3>Data Sources</h3><div>The time period for this study was from January 1994 to April 2023. Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov, euclinicaltrialsregister.eu, and Scopus were searched. The study was conducted according to the Preferred Reporting Item for Systematic Reviews guidelines and was registered with PROSPERO (CRD42023423573).</div></div><div><h3>Study Eligibility Criteria</h3><div>This was a systematic review and meta-analysis of individual patient data from randomized controlled trials comparing Dilapan-S to other mechanical or pharmacologic cervical ripening methods for labor induction in singleton gestations. The main outcome measure assessed was the cesarean delivery (CD) rate in comparing Dilapan-S to alternative methods. Secondary maternal outcomes included changes in Bishop score postintervention, vaginal delivery without complications, postpartum hemorrhage, cervical ripening issues, uterine infection, and patient satisfaction. Secondary neonatal outcomes were Apgar score <7 at 5 minutes, arterial cord pH <7.1, meconium presence, NICU admission and length of stay, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, infant infection, and infant death. This study exclusively included randomized controlled trials (RCTs) involving participants who underwent labor induction during the third trimester of a singleton pregnancy. At least one group within these trials received Dilapan-S for the purpose of cervical ripening. Trials were excluded if induction occurred prior to 37 weeks of gestation or if cervical ripening was deemed unnecessary.</div></div><div><h3>Study Appraisal and Synthesis</h3><div>Two reviewers independently selected studies, assessed the risk of bias using the Cochrane Risk of Bias Tool for RCTs, and extracted the data. Prespecified subgroup analysis was performed for parity, body mass index, Bishop score, and gestational age. Pooled odds ratios (ORs) adjusted for maternal age and parity with 95% confidence intervals (CI) were calculated using frequentist and Bayesian approaches.</div></div><div><h3>Results</h3><div>Four RCTs were identified, with 1731 women included (1036 allocated to Dilapan-S; 695 to alternative cervical ripening methods). CD rates were 28% and 30% with Dilapan-S and other methods, respectively. There was no difference in maternal age and parity-adjusted CD rates between Dilapan-S and other methods (OR 1.03, 95% CI 0.8–1.3). Bayesian inference indicated a 95% pro","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101583"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824644","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101575
Katelyn Pratt MD , Ross Lordo MD , Stella Self Ph.D. , Laura Carlson MD
<div><h3>Background</h3><div>Postpartum hypertension is an increasingly prevalent problem and optimizing its treatment is imperative in reducing maternal morbidity and improving long-term health outcomes. Despite this, data on treatment of postpartum hypertension is limited. While most available studies focus on labetalol and nifedipine ER, these medications are not frequently used for hypertension treatment in the non-obstetric setting. As we aim to establish best practices for managing postpartum hypertension, use of more commonly encountered antihypertensives should be evaluated.</div></div><div><h3>Objective</h3><div>To evaluate the use of amlodipine for the treatment of postpartum hypertension, as assessed by postpartum length of stay.</div></div><div><h3>Study Design</h3><div>In a pragmatic, randomized controlled noninferiority trial, patients were assigned to amlodipine or nifedipine ER for treatment of postpartum hypertension. The primary outcome was time from delivery until discharge with a noninferiority limit of 24 hours. A sample size of 132 was needed to achieve 80% power with a 2-tailed alpha of 0.05. Intent-to-Treat and Per Protocol analyses were performed. Prespecified secondary outcomes included the need for additional antihypertensives, side effects, medication discontinuation, breastfeeding satisfaction, and readmission rate. A post-hoc analysis of time from medication initiation until hospital discharge was also performed.</div></div><div><h3>Results</h3><div>From April 2021 to December 2022, 7618 patients were screened and 175 patients were randomized, with 132 meeting criteria for antihypertensive initiation. Baseline demographics were similar between groups. Amlodipine had a non-inferior length of stay compared to nifedipine ER (Intent-to-Treat Wilcoxon pseudo-median amlodipine=73.5 hours, nifedipine ER=72.0 hours, 95% CI -8.00 to 6.00). The remainder of analyses were performed only on the Per Protocol cohort. Time from medication initiation until hospital discharge was similar between groups (amlodipine=45.0 hours, nifedipine ER=45.5 hours, 95% CI -8.00 to 13.00). There were no differences in use of additional antihypertensives or patient-reported side effects or breastfeeding outcomes, but hypotension and tachycardia were less common with amlodipine use. Amlodipine was significantly less likely to be discontinued due to side effects (amlodipine n=0, nifedipine ER n=7 (10.1%), <em>p</em>=.02). Readmission rates were similar between groups.</div></div><div><h3>Conclusion</h3><div>Amlodipine is noninferior to nifedipine ER for postpartum hypertension treatment, as defined by median length of postpartum stay. Rates of side effects were similar between groups, but there was a statistically significant difference in medication discontinuation rates.</div><div>Clinical trial registration: Clinicaltrials.gov, <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span>, NCT04790279</div><div>El resumen está disponible
背景:产后高血压是一个日益普遍的问题,优化其治疗是降低孕产妇发病率和改善长期健康结果的必要条件。尽管如此,产后高血压的治疗数据还是有限的。虽然大多数现有的研究集中在拉贝他洛尔和硝苯地平ER,但这些药物并不经常用于非产科环境中的高血压治疗。由于我们的目标是建立管理产后高血压的最佳做法,应该评估更常见的抗高血压药物的使用。目的:评价氨氯地平对产后高血压的治疗效果,评价其产后住院时间。研究设计:在一项实用的、随机对照的非劣效性试验中,患者被分配到氨氯地平或硝苯地平ER治疗产后高血压。主要观察指标为从分娩到出院的时间,非劣效性限制为24小时。需要132个样本量才能达到80%的功效,双尾α值为0.05。进行意向治疗和每个方案分析。预先指定的次要结局包括需要额外的抗高血压药物、副作用、停药、母乳喂养满意度和再入院率。从开始用药到出院的时间也进行了事后分析。结果:2021年4月至2022年12月,共筛查7618例患者,随机纳入175例,其中132例符合降压起始标准。各组之间的基线人口统计数据相似。与硝苯地平ER相比,氨氯地平的住院时间不低于硝苯地平(意向治疗Wilcoxon伪中位数氨氯地平=73.5小时,硝苯地平ER=72.0小时,95% CI -8.00-6.00)。其余的分析仅在Per协议队列中进行。两组间从开始用药到出院的时间相似(氨氯地平=45.0小时,硝苯地平ER=45.5小时,95% CI -8.00-13.00)。在使用额外的抗高血压药物或患者报告的副作用或母乳喂养结果方面没有差异,但使用氨氯地平时低血压和心动过速较少见。氨氯地平因副作用而停药的可能性显著降低(氨氯地平n=0,硝苯地平ER n=7 (10.1%), p=0.02)。两组再入院率相似。结论:以中位产后停留时间为标准,氨氯地平治疗产后高血压的效果优于硝苯地平。两组之间的副作用发生率相似,但停药率有统计学上的显著差异。临床试验注册:Clinicaltrials.gov, www.Clinicaltrials: gov, NCT04790279。
{"title":"Amlodipine versus nifedipine ER for the management of postpartum hypertension: a noninferiority randomized controlled trial","authors":"Katelyn Pratt MD , Ross Lordo MD , Stella Self Ph.D. , Laura Carlson MD","doi":"10.1016/j.ajogmf.2024.101575","DOIUrl":"10.1016/j.ajogmf.2024.101575","url":null,"abstract":"<div><h3>Background</h3><div>Postpartum hypertension is an increasingly prevalent problem and optimizing its treatment is imperative in reducing maternal morbidity and improving long-term health outcomes. Despite this, data on treatment of postpartum hypertension is limited. While most available studies focus on labetalol and nifedipine ER, these medications are not frequently used for hypertension treatment in the non-obstetric setting. As we aim to establish best practices for managing postpartum hypertension, use of more commonly encountered antihypertensives should be evaluated.</div></div><div><h3>Objective</h3><div>To evaluate the use of amlodipine for the treatment of postpartum hypertension, as assessed by postpartum length of stay.</div></div><div><h3>Study Design</h3><div>In a pragmatic, randomized controlled noninferiority trial, patients were assigned to amlodipine or nifedipine ER for treatment of postpartum hypertension. The primary outcome was time from delivery until discharge with a noninferiority limit of 24 hours. A sample size of 132 was needed to achieve 80% power with a 2-tailed alpha of 0.05. Intent-to-Treat and Per Protocol analyses were performed. Prespecified secondary outcomes included the need for additional antihypertensives, side effects, medication discontinuation, breastfeeding satisfaction, and readmission rate. A post-hoc analysis of time from medication initiation until hospital discharge was also performed.</div></div><div><h3>Results</h3><div>From April 2021 to December 2022, 7618 patients were screened and 175 patients were randomized, with 132 meeting criteria for antihypertensive initiation. Baseline demographics were similar between groups. Amlodipine had a non-inferior length of stay compared to nifedipine ER (Intent-to-Treat Wilcoxon pseudo-median amlodipine=73.5 hours, nifedipine ER=72.0 hours, 95% CI -8.00 to 6.00). The remainder of analyses were performed only on the Per Protocol cohort. Time from medication initiation until hospital discharge was similar between groups (amlodipine=45.0 hours, nifedipine ER=45.5 hours, 95% CI -8.00 to 13.00). There were no differences in use of additional antihypertensives or patient-reported side effects or breastfeeding outcomes, but hypotension and tachycardia were less common with amlodipine use. Amlodipine was significantly less likely to be discontinued due to side effects (amlodipine n=0, nifedipine ER n=7 (10.1%), <em>p</em>=.02). Readmission rates were similar between groups.</div></div><div><h3>Conclusion</h3><div>Amlodipine is noninferior to nifedipine ER for postpartum hypertension treatment, as defined by median length of postpartum stay. Rates of side effects were similar between groups, but there was a statistically significant difference in medication discontinuation rates.</div><div>Clinical trial registration: Clinicaltrials.gov, <span><span>www.clinicaltrials.gov</span><svg><path></path></svg></span>, NCT04790279</div><div>El resumen está disponible","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101575"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814247","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 : 2025-01-01DOI: 10.1016/j.ajogmf.2024.101581
Pei Zhang MD , Yifan Fan MD , Hui Song MD , Yan Lv MD , Hao Geng PhD , Pingchuan Ma PhD , Hongyan Cui MD , Yanju Jia PhD , Xu Chen MD
Background
Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide, particularly in resource-limited settings. Enhancing maternal safety in relation to PPH requires optimizing care protocols, continuous monitoring, and timely interventions. However, integrating these methodologies into vaginal delivery practices remains underexplored.
Objective
To assess the impact and sustainability of a recently implemented Strategies and Tools to Enhance Parturient Safety (STEPS) program on PPH management.
Methods
This before-and-after study included women who delivered vaginally between January 2020 and November 2023. Clinical practices and PPH-related outcomes were compared for 2-year periods before and after STEPS implementation, initiated in January 2022. The program involved enhanced perinatal care bundles, interdisciplinary team training, and continuous monitoring using statistical process control (SPC) tools. The primary outcome was PPH incidence (≥500 mL blood loss within 24 hours).
Results
During the 4-year observation period, 24,235 women underwent vaginal deliveries. The incidence of PPH was 11.1% (1,473/13272) before STEPS and 11.8% (1,293/10963) after STEPS (aRR, 1.09; 95% CI, 1.00–1.18; P=.042). Severe PPH rates remained unchanged (aRR, 1.09; 95% CI, 0.90–1.33; P=.391). However, the proportion requiring blood transfusion significantly decreased (aRR, 0.77; 95% CI, 0.61–0.98; P=.035). Compared to preintervention period, a higher proportion of women experiencing PPH were identified as being at elevated risk prior to delivery in the postintervention period (P<.001). Notably, blood transfusion rates (P=.047) and hospital stay durations for women with PPH (P<.001) significantly declined.
Conclusions
The STEPS program effectively improved PPH management by enhancing risk identification, increasing targeted interventions, and reducing blood transfusion rates and hospital stays. These findings highlight the importance of a comprehensive approach that integrates risk assessment, monitoring, and tailored interventions for managing PPH in vaginal deliveries, particularly in resource-limited settings.
{"title":"Step forward: implementation and evaluation of STEPS program to optimize postpartum hemorrhage management in vaginal deliveries","authors":"Pei Zhang MD , Yifan Fan MD , Hui Song MD , Yan Lv MD , Hao Geng PhD , Pingchuan Ma PhD , Hongyan Cui MD , Yanju Jia PhD , Xu Chen MD","doi":"10.1016/j.ajogmf.2024.101581","DOIUrl":"10.1016/j.ajogmf.2024.101581","url":null,"abstract":"<div><h3>Background</h3><div>Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide, particularly in resource-limited settings. Enhancing maternal safety in relation to PPH requires optimizing care protocols, continuous monitoring, and timely interventions. However, integrating these methodologies into vaginal delivery practices remains underexplored.</div></div><div><h3>Objective</h3><div>To assess the impact and sustainability of a recently implemented Strategies and Tools to Enhance Parturient Safety (STEPS) program on PPH management.</div></div><div><h3>Methods</h3><div>This before-and-after study included women who delivered vaginally between January 2020 and November 2023. Clinical practices and PPH-related outcomes were compared for 2-year periods before and after STEPS implementation, initiated in January 2022. The program involved enhanced perinatal care bundles, interdisciplinary team training, and continuous monitoring using statistical process control (SPC) tools. The primary outcome was PPH incidence (≥500 mL blood loss within 24 hours).</div></div><div><h3>Results</h3><div>During the 4-year observation period, 24,235 women underwent vaginal deliveries. The incidence of PPH was 11.1% (1,473/13272) before STEPS and 11.8% (1,293/10963) after STEPS (aRR, 1.09; 95% CI, 1.00–1.18; <em>P</em>=.042). Severe PPH rates remained unchanged (aRR, 1.09; 95% CI, 0.90–1.33; <em>P</em>=.391). However, the proportion requiring blood transfusion significantly decreased (aRR, 0.77; 95% CI, 0.61–0.98; <em>P</em>=.035). Compared to preintervention period, a higher proportion of women experiencing PPH were identified as being at elevated risk prior to delivery in the postintervention period (<em>P</em><.001). Notably, blood transfusion rates (<em>P</em>=.047) and hospital stay durations for women with PPH (<em>P</em><.001) significantly declined.</div></div><div><h3>Conclusions</h3><div>The STEPS program effectively improved PPH management by enhancing risk identification, increasing targeted interventions, and reducing blood transfusion rates and hospital stays. These findings highlight the importance of a comprehensive approach that integrates risk assessment, monitoring, and tailored interventions for managing PPH in vaginal deliveries, particularly in resource-limited settings.</div></div>","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"7 1","pages":"Article 101581"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142830217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}