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False-Positive Human Immunodeficiency Virus-1 Test Results With Rapid Seroreversion After Third-Trimester Tdap Booster Vaccination. 接种第三胎百白破强化疫苗后血清迅速恢复的假阳性人类免疫缺陷病毒-1 检测结果。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-13 DOI: 10.1097/AOG.0000000000005726
Karl O A Yu, Seth R Glassman, Heather M Link

Background: False-positive and false-negative results in human immunodeficiency virus (HIV) testing are expected at some frequency. False-positive results have been reported in association with various conditions, including pregnancy, autoimmune disease, and infection. We present an atypical case of a pregnant patient receiving false-positive HIV results for both screening and antibody confirmatory tests after a recent routine vaccination.

Case: A 34-year-old woman, G4P1021, with a negative first-trimester HIV test result received a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) booster at 35 2/7 weeks of gestation. Test results at 36 2/7 weeks of gestation were positive in both HIV-1/2 antigen-antibody screening and a confirmatory HIV-1 antibody differentiation immunoassay, but follow-up test results at 36 5/7 weeks and later were negative. Repeat testing and erythrocyte typing confirmed that this was not a result of laboratory error or specimen mishandling. HIV antiretroviral therapy was started and was later discontinued. A scheduled primary cesarean delivery performed at 39 1/7 weeks of gestation due to breech presentation was uncomplicated.

Conclusions: False-positive results in HIV screen and confirmation testing were associated with receipt of a Tdap vaccine booster 7 days prior. This test result pattern is similar to that seen very rarely in previous cases, and the rapid seroreversion to negative suggests an acute immunologic trigger leading to a falsely reactive antibody. Clinicians should be aware of the potential for false-positive HIV test results in patients who recently received vaccination or with other immune triggers and retest at a short interval if suspected.

背景:在人类免疫缺陷病毒(HIV)检测中,假阳性和假阴性结果会经常出现。据报道,假阳性结果与各种情况有关,包括怀孕、自身免疫性疾病和感染。我们报告了一个非典型病例,一名怀孕患者在最近接种常规疫苗后,在筛查和抗体确证试验中均出现了艾滋病病毒假阳性结果:病例:一名 34 岁的女性(G4P1021)在妊娠 35 2/7 周时接受了破伤风类毒素、白喉类毒素和无细胞百日咳(Tdap)强化免疫接种,第一次妊娠 HIV 检测结果为阴性。妊娠 36 2/7 周时,HIV-1/2 抗原-抗体筛查和确证 HIV-1 抗体分化免疫测定的检测结果均为阳性,但 36 5/7 周及以后的后续检测结果均为阴性。重复检测和红细胞分型证实,这不是实验室失误或样本处理不当造成的。患者开始接受艾滋病毒抗逆转录病毒治疗,后来又停止了治疗。在妊娠 39 1/7 周时,因臀先露而进行了一次原定的剖宫产,过程并不复杂:结论:HIV 筛查和确认检测的假阳性结果与 7 天前接种过百白破疫苗加强剂有关。这种检测结果模式与以往病例中极少见的模式相似,血清迅速转阴表明是急性免疫触发导致了假阳性反应。临床医生应注意近期接种过疫苗或有其他免疫诱因的患者可能会出现艾滋病检测结果假阳性的情况,如果怀疑会出现这种情况,应在短时间内重新检测。
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引用次数: 0
Management of Vulvovaginal Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. 外阴史蒂文斯-约翰逊综合征和中毒性表皮坏死松解症的处理方法。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-12 DOI: 10.1097/AOG.0000000000005725
Erin E Ross, Rachel C Knapp, Marcia A Ciccone, Warren L Garner, T Justin Gillenwater, Haig A Yenikomshian

Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) is an autoimmune process resulting in painful epidermal sloughing that can involve the vulva and vagina. Current guideline recommendations are based on expert opinion and may not reflect modern management of SJS/TEN in burn centers. We performed a retrospective chart review of 34 female patients treated for SJS/TEN at our burn center from 2015 to 2023. Cases frequently involved the vulva (83.3%) and vagina (56.0%), though pelvic examination often was limited. For eight patients with confirmed vulvovaginal lesions, there were no direct sequelae of SJS/TEN requiring intervention. In the modern era of SJS/TEN management in burn centers, interventions such as steroids may not be needed.

史蒂文斯-约翰逊综合征和中毒性表皮坏死(SJS/TEN)是一种自身免疫过程,会导致表皮脱落,外阴和阴道也会受到感染。目前的指南建议基于专家意见,可能无法反映烧伤中心对 SJS/TEN 的现代管理。我们对 2015 年至 2023 年期间在烧伤中心接受 SJS/TEN 治疗的 34 名女性患者进行了回顾性病历审查。病例经常涉及外阴(83.3%)和阴道(56.0%),但盆腔检查往往有限。8例确诊为外阴阴道病变的患者没有出现需要干预的SJS/TEN直接后遗症。在烧伤中心进行SJS/TEN治疗的现代,可能不需要类固醇等干预措施。
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引用次数: 0
Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial. 坦索罗辛与子宫切除术后自然排气时间:随机对照试验。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-12 DOI: 10.1097/AOG.0000000000005724
Martina Gabra, Christine Hall, Lelan McCann, Jeenal Shah, Ismael Jones, Aaron Masjedi, Stephanie Runke, Chiu-Hsieh Hsu, Andrea Aguirre

Objective: To evaluate whether a single preoperative dose of tamsulosin reduces the time to postoperative void and time to discharge in patients who are undergoing minimally invasive hysterectomy.

Methods: This single-center, block-randomized, placebo-controlled, double-blind superiority trial evaluated the effect of 0.4 mg tamsulosin compared with placebo on the time to void after hysterectomy. Patients who underwent outpatient minimally invasive hysterectomy were randomized to a single dose of tamsulosin or placebo 1 hour before surgery. All participants underwent a standardized backfill void trial to eliminate discrepancies in bladder volume that would otherwise affect the time to void. For our primary aim, we planned to enroll 150 participants to show a 30-minute reduction in the time to postoperative void (80% power, α<0.05). The secondary aim was to compare the time to discharge from the postanesthesia care unit.

Results: From June 2021 through January 2023, 344 patients were screened, and 150 were included in the final data analysis: 77 in the tamsulosin group and 73 in the placebo group. The time to spontaneous void was not different between the tamsulosin and placebo groups (106 minutes vs 100 minutes, P=.5). In addition, there was no statistical difference in time to discharge from the postanesthesia care unit (144 minutes vs 156 minutes, P=.4). Demographics and surgical details were not different between each group.

Conclusion: A single dose of tamsulosin preoperatively does not lead to a decrease in postoperative time to void or time to discharge in patients undergoing minimally invasive hysterectomy for benign conditions.

Clinical trial registration: ClinicalTrials.gov, NCT04859660.

目的评估术前单次服用坦索罗辛是否能缩短微创子宫切除术患者的术后排空时间和出院时间:这项单中心、整群随机、安慰剂对照、双盲优效试验评估了 0.4 毫克坦索罗辛与安慰剂相比对子宫切除术后排空时间的影响。接受门诊微创子宫切除术的患者在术前 1 小时随机接受单剂量坦索罗辛或安慰剂治疗。所有参与者都接受了标准化的后填排尿试验,以消除膀胱容量差异对排尿时间的影响。对于我们的主要目标,我们计划招募 150 名参与者,以显示术后排尿时间缩短了 30 分钟(80% 功率,α 结果:从 2021 年 6 月到 2023 年 1 月,共筛选出 344 名患者,其中 150 人被纳入最终数据分析:坦索罗辛组 77 人,安慰剂组 73 人。坦索罗辛组和安慰剂组的自主排尿时间没有差异(106 分钟 vs 100 分钟,P=.5)。此外,从麻醉后护理病房出院的时间也没有统计学差异(144 分钟 vs 156 分钟,P=.4)。各组的人口统计学和手术细节没有差异:结论:术前服用单剂量坦索罗辛不会导致因良性疾病接受微创子宫切除术的患者术后排空时间或出院时间缩短:临床试验注册:ClinicalTrials.gov,NCT04859660。
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引用次数: 0
Effects of Antihypertensive Therapy During Pregnancy on Postpartum Blood Pressure Control. 孕期降压治疗对产后血压控制的影响
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-12 DOI: 10.1097/AOG.0000000000005715
Samantha L Martin, Hui-Chien Kuo, Kim Boggess, Lorraine Dugoff, Baha Sibai, Kirsten Lawrence, Brenna L Hughes, Joseph Bell, Kjersti Aagaard, Kelly S Gibson, David M Haas, Lauren Plante, Torri D Metz, Brian M Casey, Sean Esplin, Sherri Longo, Matthew Hoffman, George R Saade, Janelle Foroutan, Methodius G Tuuli, Michelle Y Owens, Hyagriv N Simhan, Heather A Frey, Todd Rosen, Anna Palatnik, Susan Baker, Phyllis August, Uma M Reddy, Wendy Kinzler, Emily J Su, Iris Krishna, Nicki Nguyen, Mary E Norton, Daniel Skupski, Yasser Y El-Sayed, Dotun Ogunyemi, Zorina S Galis, Namasivayam Ambalavanan, Suzanne Oparil, Ronald Librizzi, Leonardo Pereira, Everett F Magann, Mounira Habli, Shauna Williams, Giancarlo Mari, Gabriella Pridjian, David S McKenna, Marc Parrish, Eugene Chang, Sarah Osmundson, JoAnne Quinones, Erika Werner, Jeff M Szychowski, Alan T N Tita

Objective: To compare differences in postpartum blood pressure (BP) control (BP below 140/90 mm Hg) for participants with hypertension randomized to receive antihypertensive treatment compared with no treatment during pregnancy.

Methods: This study was a planned secondary analysis of a multicenter, open-label, randomized controlled trial (The CHAP [Chronic Hypertension and Pregnancy] trial). Pregnant participants with mild chronic hypertension (BP below 160/105 mm Hg) were randomized into two groups: active (antihypertensive treatment) or control (no treatment unless severe hypertension, BP 160/105 mm Hg or higher). Study outcomes were BP control below 140/90 mm Hg (primary) and medication nonadherence based on a composite score threshold (secondary) at the 6-week postpartum follow-up visit. Participants without follow-up BP measurements were excluded from analysis of the BP control outcome. Participants without health care professional-prescribed antihypertensives at delivery were excluded from the analysis of the adherence outcome. Multivariable logistic regression was used to adjust for potential confounders.

Results: Of 2,408 participants, 1,684 (864 active, 820 control) were included in the analysis. A greater percentage of participants in the active group achieved BP control (56.7% vs 51.5%; adjusted odds ratio [aOR] 1.22, 95% CI, 1.00-1.48) than in the control group. Postpartum antihypertensive prescription was higher in the active group (81.7% vs 58.4%, P<.001), and nonadherence did not differ significantly between groups (aOR 0.81, 95% CI, 0.64-1.03).

Conclusion: Antihypertensive treatment of mild chronic hypertension during pregnancy was associated with better BP control below 140/90 mm Hg in the immediate postpartum period.

目的比较随机接受降压治疗的高血压患者与孕期未接受治疗的患者在产后血压控制(血压低于 140/90 mm Hg)方面的差异:本研究是对一项多中心、开放标签、随机对照试验(CHAP[慢性高血压与妊娠]试验)的二次分析。患有轻度慢性高血压(血压低于 160/105 mm Hg)的孕妇被随机分为两组:积极组(抗高血压治疗)或对照组(除非严重高血压,血压为 160/105 mm Hg 或更高)。研究结果为血压控制在 140/90 mm Hg 以下(主要结果)和产后 6 周随访时根据综合评分阈值得出的药物治疗不依从性(次要结果)。在分析血压控制结果时,未进行随访血压测量的参与者被排除在外。在分析依从性结果时,不包括分娩时没有医护人员开具降压药处方的参与者。多变量逻辑回归用于调整潜在的混杂因素:在 2,408 名参与者中,1,684 人(864 名积极参与者,820 名对照组参与者)被纳入分析。与对照组相比,积极治疗组达到血压控制的比例更高(56.7% vs 51.5%;调整后的几率比 [aOR] 1.22,95% CI,1.00-1.48)。积极治疗组的产后抗高血压处方率更高(81.7% 对 58.4%):妊娠期轻度慢性高血压的降压治疗与产后血压更好地控制在 140/90 mm Hg 以下有关。
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引用次数: 0
Navigating the Legal Landscape of Reproductive Rights and Medical Training After LePage v. Mobile Infirmary Clinic. LePage 诉 Mobile Infirmary Clinic 案之后,生殖权利和医疗培训的法律前景。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-12 DOI: 10.1097/AOG.0000000000005728
Alexandra Herweck, Ariana M Traub, Lisa M Shandley
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引用次数: 0
Compliance Rate With Triage Test and Treatment for Participants Screening Positive in Cervical Cancer Screening Programs: A Systematic Review and Meta-analysis. 宫颈癌筛查计划中筛查阳性参与者的分诊测试和治疗依从率:系统回顾与元分析》。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-12 DOI: 10.1097/AOG.0000000000005723
Minmin Wang, Mailikezhati Maimaitiming, Yanxin Bi, Yinzi Jin

Objective: To assess the rates of adherence to triage testing after positive screening results and referral to treatment for precancerous lesions in global cervical cancer screening programs.

Data sources: We searched three electronic databases (Medline, EMBASE, and Web of Science) for articles published in the English language from January 1, 2018, to December 31, 2023. We included studies reporting the compliance rate of triage testing and precancer treatment in cervical cancer screening programs. ClinicalTrials.gov was reviewed, and no more studies were identified.

Methods of study selection: The combined search strategies identified 1,673 titles, of which 858 titles and abstracts were screened and 113 full-text articles were assessed for eligibility. A total of 33 studies met the inclusion criteria and were included in the meta-analysis.

Tabulation, integration, and results: Thirty-three studies were included in the systematic review and meta-analysis. The average compliance rate for women screening positive was 77.1% for triage testing and 69.4% for referral to treatment. Compliance varied by country income level, screening guideline approach, and target population.

Conclusion: The current compliance rate was lower than the 90% target set by the World Health Organization's global strategy to eliminate cervical cancer. Inadequate follow-up of participants screening positive revealed a gap between the screening program and clinical care.

目的评估全球宫颈癌筛查项目中筛查结果呈阳性后坚持分流检测以及癌前病变转诊治疗的比例:我们检索了三个电子数据库(Medline、EMBASE 和 Web of Science)中自 2018 年 1 月 1 日至 2023 年 12 月 31 日以英文发表的文章。我们纳入了报告宫颈癌筛查项目中分流检测和癌前病变治疗达标率的研究。对ClinicalTrials.gov进行了审查,没有发现更多的研究:综合搜索策略确定了 1,673 篇标题,筛选了其中 858 篇标题和摘要,并对 113 篇全文进行了资格评估。共有 33 项研究符合纳入标准并被纳入荟萃分析:有 33 项研究被纳入系统综述和荟萃分析。筛查结果呈阳性的妇女接受分流检测的平均依从率为 77.1%,接受转诊治疗的平均依从率为 69.4%。不同国家的收入水平、筛查指南方法和目标人群的符合率各不相同:目前的符合率低于世界卫生组织消除宫颈癌全球战略设定的 90% 的目标。对筛查结果呈阳性的参与者的随访不足表明筛查计划与临床治疗之间存在差距。
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引用次数: 0
Rh D Immune Globulin Administration After Abortion or Pregnancy Loss at Less Than 12 Weeks of Gestation. 妊娠不足 12 周的流产或妊娠失败后注射 Rh D 免疫球蛋白。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-10 DOI: 10.1097/AOG.0000000000005733

This Clinical Practice Update provides revised guidance on Rh testing and Rh D immune globulin administration for individuals undergoing abortion or experiencing pregnancy loss at less than 12 0/7 weeks of gestation. This document updates Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation (Obstet Gynecol 2020;136:e31-47); Practice Bulletin No. 200, Early Pregnancy Loss (Obstet Gynecol 2018;132:e197-207); and Practice Bulletin No. 181, Prevention of Rh D Alloimmunization (Obstet Gynecol 2017;130:e57-70).

本《临床实践更新》为妊娠不足 12 0/7 周时进行人工流产或妊娠流产的患者提供了 Rh 检测和 Rh D 免疫球蛋白注射的修订指南。本文件更新了第225号实践公告《妊娠70天以内的药物流产》(Obstet Gynecol 2020;136:e31-47)、第200号实践公告《早期妊娠丢失》(Obstet Gynecol 2018;132:e197-207)和第181号实践公告《Rh D同种免疫的预防》(Obstet Gynecol 2017;130:e57-70)。
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引用次数: 0
Association Between Metformin Use in Early Gestational or Type 2 Diabetes in Pregnancy and Preterm Preeclampsia. 妊娠早期或妊娠 2 型糖尿病患者服用二甲双胍与先兆子痫之间的关系。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-05 DOI: 10.1097/AOG.0000000000005720
Maya Patel, Ashley N Battarbee, Jerrie S Refuerzo, Noelia Zork, Kacey Eichelberger, Gladys A Ramos, Gayle Olson, Celeste Durnwald, Mark B Landon, Kjersti M Aagaard, Kedra Wallace, Christina Scifres, Todd Rosen, Wadia Mulla, Amy Valent, Sherri Longo, Kim A Boggess

Objective: To estimate the association between maternal metformin use for the treatment of early gestational or pre-existing type 2 diabetes and preterm preeclampsia.

Methods: This is a planned secondary analysis of the MOMPOD study (Medical Optimization of Management of Overt Type 2 Diabetes in Pregnancy), a randomized trial comparing the effect of adding metformin with insulin treatment on composite neonatal outcome in singleton pregnancies with early gestational or type 2 diabetes. Participants were randomized at 11-23 weeks of gestation to 1,000 mg metformin twice daily or placebo until delivery. A subset of participants had maternal blood collected at 24-30 weeks of gestation, and serum soluble endoglin, apolipoprotein B, vascular cell adhesion molecule-1, soluble fms-like tyrosine kinase 1, placental growth factor, high-sensitivity C-reactive protein, adiponectin, and vascular endothelial growth factor levels were measured. Our primary outcome was preterm preeclampsia, defined as preeclampsia requiring delivery before 37 weeks of gestation. Secondary outcomes included preterm preeclampsia requiring delivery before 34 weeks of gestation and differences in serum biomarkers. Multivariable regression analysis was used to estimate the associations between metformin use and primary or secondary study outcomes.

Results: Of 831 participants, 119 (14.3%) developed preeclampsia requiring delivery before 37 weeks of gestation: 57 of 416 (13.7%) in the placebo group and 62 of 415 (14.9%) in the metformin group. Thirty-seven (4.4%) developed preeclampsia requiring delivery before 34 weeks of gestation: 15 (3.6%) receiving placebo and 22 (5.3%) receiving metformin. Compared with placebo, metformin was not associated with a significant difference in the occurrence of preeclampsia before 37 weeks of gestation (adjusted odds ratio [aOR] 1.04, 95% CI, 0.70-1.56) or before 34 weeks (aOR 1.43, 95% CI, 0.73-2.81). Similarly, there was no association between maternal metformin use and serum biomarker levels.

Conclusion: Among parturients with early gestational or pre-existing type 2 diabetes, the addition of metformin to insulin was not associated with lower odds of preterm preeclampsia or with serum biomarkers associated with cardiovascular disease risk.

目的估计孕产妇使用二甲双胍治疗妊娠早期或既往2型糖尿病与早产子痫前期之间的关系:这是 MOMPOD 研究(妊娠合并 2 型糖尿病的医学优化管理)的一项计划性二次分析,该研究是一项随机试验,比较在妊娠早期或 2 型糖尿病患者的单胎妊娠中添加二甲双胍和胰岛素治疗对新生儿综合结局的影响。参与者在妊娠 11-23 周时被随机分配到每日两次、每次 1000 毫克的二甲双胍或安慰剂中,直至分娩。一部分参与者在妊娠 24-30 周时采集了母体血液,并测定了血清可溶性内皮素、脂蛋白 B、血管细胞粘附分子-1、可溶性 fms 样酪氨酸激酶 1、胎盘生长因子、高敏 C 反应蛋白、脂肪连素和血管内皮生长因子的水平。我们的主要结果是早产子痫前期,即需要在妊娠 37 周前分娩的子痫前期。次要结果包括需要在妊娠 34 周前分娩的先兆子痫和血清生物标志物的差异。多变量回归分析用于估计二甲双胍的使用与主要或次要研究结果之间的关联:在 831 名参与者中,有 119 人(14.3%)在妊娠 37 周前患上需要分娩的子痫前期:安慰剂组416人中有57人(13.7%)出现子痫前期,二甲双胍组415人中有62人(14.9%)出现子痫前期。37例(4.4%)先兆子痫患者需要在妊娠34周前分娩:其中 15 人(3.6%)服用安慰剂,22 人(5.3%)服用二甲双胍。与安慰剂相比,二甲双胍与妊娠 37 周前(调整后比值比 [aOR] 1.04,95% CI,0.70-1.56)或 34 周前(调整后比值比 1.43,95% CI,0.73-2.81)发生子痫前期的差异不大。同样,产妇服用二甲双胍与血清生物标志物水平之间也没有关联:结论:在妊娠早期或已存在2型糖尿病的产妇中,在胰岛素基础上加用二甲双胍与降低先兆子痫发生几率或与心血管疾病风险相关的血清生物标志物无关。
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引用次数: 0
Glycemic Control and Risk of Congenital Malformations in Women With Type 1 Diabetes. 1 型糖尿病女性患者的血糖控制与先天性畸形风险。
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-05 DOI: 10.1097/AOG.0000000000005722
Ida Holte Thorius, Janne Petersen, Lise Lotte N Husemoen, Amra C Alibegovic, Mari-Anne Gall, Peter Damm, Elisabeth R Mathiesen

Objective: To investigate the association between maternal glycemic control and the risk of congenital malformations in offspring of women with type 1 diabetes and to examine whether there is a hemoglobin A1C (Hb A1C) threshold value at which the risk for malformations increases significantly.

Methods: Analyses were performed on data from a multinational, observational cohort of 1,908 liveborn offspring of women with type 1 diabetes recruited in early pregnancy from 17 countries between 2013 and 2018. Offspring with malformations were identified according to European Surveillance of Congenital Anomalies version 1.4 and categorized as having one or more major malformations or minor malformations exclusively. The association between first-trimester Hb A1C levels and the risk of congenital malformations was investigated with splines in crude and adjusted logistic regression models.

Results: In total, 11.9% of the offspring (n=227) of women with type 1 diabetes had congenital malformations, including 2.1% (n=40) with at least one severe malformation. Women giving birth to offspring with malformations had a higher prevalence of psychiatric disorders (13.2% vs 7.2%, P<.01), thyroid disorders (33.0% vs 26.7%, P<.05), and folic acid supplementation (87.1% vs 77.7%, P<.01). The Hb A1C levels in the first trimester were similar (median 6.8% [interquartile range 6.3-7.6%] vs 6.7% [6.2-7.6%], P=.13) compared with women giving birth to offspring without malformations. The spline analysis illustrated a curvilinear association between Hb A1C levels and the risk of malformations with no clear threshold values. Higher first-trimester Hb A1C levels were associated with an increased risk of malformations (crude odds ratio [OR] 1.13, 95% CI, 1.01-1.27, adjusted odds ratio [aOR] 1.29, 95% CI, 1.10-1.51) and major malformations (crude OR 1.49, 95% CI, 1.23-1.81, aOR 1.57, 95% CI, 1.15-2.09).

Conclusion: An increased risk for congenital malformations was curvilinearly associated with higher Hb A1C levels in early pregnancy among women with type 1 diabetes without any threshold values identified.

Clinical trial registration: ClinicalTrials.gov, NCT01892319.

目的研究母体血糖控制与1型糖尿病女性后代先天性畸形风险之间的关系,并探讨是否存在一个血红蛋白A1C(Hb A1C)阈值,在该阈值处畸形风险会显著增加:对2013年至2018年期间从17个国家招募的1908名1型糖尿病女性早孕期活产后代的多国观察性队列数据进行了分析。根据欧洲先天性畸形监测1.4版确定了患有畸形的后代,并将其分为患有一种或多种主要畸形或仅患有轻微畸形。在粗略和调整后的逻辑回归模型中,使用劈叉法研究了第一胎血红蛋白 A1C 水平与先天性畸形风险之间的关系:1型糖尿病妇女的后代(样本数=227)中,共有11.9%患有先天性畸形,其中2.1%(样本数=40)至少患有一种严重畸形。生下畸形后代的妇女患精神疾病的比例更高(13.2% 对 7.2%,PC结论:在1型糖尿病妇女中,先天性畸形风险的增加与妊娠早期较高的血红蛋白A1C水平呈曲线关系,但未确定任何临界值:临床试验注册:ClinicalTrials.gov,NCT01892319。
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引用次数: 0
Panniculus Retractor Use for Visualization of Fetal Anatomy: A Randomized Controlled Trial. 使用环形牵引器观察胎儿解剖:随机对照试验
IF 5.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-25 DOI: 10.1097/AOG.0000000000005689
Melissa L Wise, Marvin Okon, Katelyn N Pratt, Andrew S Lane, Laura M Carlson, Kacey Y Eichelberger, Amy H Crockett, Lu Zhang, Daniel N Pasko

Objective: To evaluate whether use of a panniculus retractor device for pregnant patients with body mass index (BMI) 40 or higher and a panniculus improves the completion rate of the fetal anatomic examination.

Methods: This was a randomized trial in which eligible patients with BMI 40 or higher and a panniculus were randomized to undergo their detailed fetal anatomic examination with a panniculus retractor device in place compared with usual care. The primary outcome was the completion rate of 16 prespecified views from the anatomic examination. Secondary outcomes included completion rate of all 64 views from our institution's detailed anatomic examination, duration of examination, major fetal anomaly detection rate, depth from the skin to amniotic cavity before and after retractor placement, patient and ultrasonographer satisfaction, and prespecified adverse events. We assumed a baseline completion rate of 23% for the primary outcome and targeted a twofold improvement with 80% power and two-sided α of 0.05, which resulted in a sample size of 132 participants. The goal enrollment was increased to 150 participants to account for potential dropout. Statistical tests included the Student's t test, χ 2 , and relative risks (RRs) as appropriate.

Results: From March to July of 2023, 150 participants completed the study: 74 in the retractor group and 76 in the usual care group. Baseline characteristics were similar between groups except for panniculus grade. The completion rate of 16 prespecified views was 25.7% (19/74) in the retractor group and 31.6% (24/76) in the control group (RR 0.81, 95% CI, 0.49-1.35). There were no significant differences between groups for any of the secondary outcomes. Patient satisfaction and ultrasonographer satisfaction were similar between groups.

Conclusion: Use of a panniculus retractor device during the fetal anatomic examination for patients with BMI 40 or higher and a panniculus was well tolerated by patients and ultrasonographers but did not improve the completion rate of 16 prespecified fetal anatomic views.

Clinical trial registration: ClinicalTrials.gov , NCT05764408.

目的评估对体重指数(BMI)大于或等于 40 且有脐带绕颈的孕妇使用脐带牵引器是否能提高胎儿解剖检查的完成率:这是一项随机试验,与常规护理相比,符合条件的体重指数(BMI)为 40 或以上且有脐带的患者被随机分配到安装了脐带牵引装置的医院接受详细的胎儿解剖检查。主要结果是解剖检查中 16 个预先指定视图的完成率。次要结果包括本机构详细解剖检查中所有 64 个切面的完成率、检查持续时间、主要胎儿异常检出率、放置牵引器前后皮肤到羊膜腔的深度、患者和超声技师的满意度以及预先指定的不良事件。我们假设主要结果的基线完成率为 23%,目标是在功率为 80% 且双侧 α 为 0.05 的情况下提高两倍,因此样本量为 132 人。考虑到可能出现的辍学情况,目标注册人数增加到 150 人。统计检验包括学生 t 检验、χ2 和适当的相对风险 (RR):从 2023 年 3 月到 7 月,150 名参与者完成了研究:牵引器组 74 人,常规护理组 76 人。各组之间的基线特征相似,但泛酸等级除外。牵引器组 16 个预设视图的完成率为 25.7%(19/74),对照组为 31.6%(24/76)(RR 0.81,95% CI,0.49-1.35)。各组间的次要结果无明显差异。两组患者的满意度和超声波医师的满意度相似:结论:对于体重指数(BMI)40或更高且有绒毛膜的患者,在胎儿解剖检查过程中使用绒毛膜牵开器对患者和超声技师的耐受性良好,但并未提高16个预先指定的胎儿解剖视图的完成率:临床试验注册:ClinicalTrials.gov,NCT05764408。
{"title":"Panniculus Retractor Use for Visualization of Fetal Anatomy: A Randomized Controlled Trial.","authors":"Melissa L Wise, Marvin Okon, Katelyn N Pratt, Andrew S Lane, Laura M Carlson, Kacey Y Eichelberger, Amy H Crockett, Lu Zhang, Daniel N Pasko","doi":"10.1097/AOG.0000000000005689","DOIUrl":"10.1097/AOG.0000000000005689","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate whether use of a panniculus retractor device for pregnant patients with body mass index (BMI) 40 or higher and a panniculus improves the completion rate of the fetal anatomic examination.</p><p><strong>Methods: </strong>This was a randomized trial in which eligible patients with BMI 40 or higher and a panniculus were randomized to undergo their detailed fetal anatomic examination with a panniculus retractor device in place compared with usual care. The primary outcome was the completion rate of 16 prespecified views from the anatomic examination. Secondary outcomes included completion rate of all 64 views from our institution's detailed anatomic examination, duration of examination, major fetal anomaly detection rate, depth from the skin to amniotic cavity before and after retractor placement, patient and ultrasonographer satisfaction, and prespecified adverse events. We assumed a baseline completion rate of 23% for the primary outcome and targeted a twofold improvement with 80% power and two-sided α of 0.05, which resulted in a sample size of 132 participants. The goal enrollment was increased to 150 participants to account for potential dropout. Statistical tests included the Student's t test, χ 2 , and relative risks (RRs) as appropriate.</p><p><strong>Results: </strong>From March to July of 2023, 150 participants completed the study: 74 in the retractor group and 76 in the usual care group. Baseline characteristics were similar between groups except for panniculus grade. The completion rate of 16 prespecified views was 25.7% (19/74) in the retractor group and 31.6% (24/76) in the control group (RR 0.81, 95% CI, 0.49-1.35). There were no significant differences between groups for any of the secondary outcomes. Patient satisfaction and ultrasonographer satisfaction were similar between groups.</p><p><strong>Conclusion: </strong>Use of a panniculus retractor device during the fetal anatomic examination for patients with BMI 40 or higher and a panniculus was well tolerated by patients and ultrasonographers but did not improve the completion rate of 16 prespecified fetal anatomic views.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov , NCT05764408.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141760105","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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Obstetrics and gynecology
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