King Caroline, Parker T Maxwell, Roussos-Ross Kay, Ramirez-Zamora Adolfo, Smulian John C, Okun Michael S, Wong Joshua K
Department of Obstetrics & Gynecology, University of Florida College of Medicine, Gainesville, FL, United States.
Department of Neurology, Norman Fixel Institute for Neurological Diseases, University of Florida College of Medicine, Gainesville, FL, United States.
Front Hum Neurosci. 2022 Sep 29;16:997552. doi: 10.3389/fnhum.2022.997552. eCollection 2022.
Deep brain stimulation (DBS) is increasingly used to treat the symptoms of various neurologic and psychiatric conditions. People can undergo the procedure during reproductive years but the safety of DBS in pregnancy remains relatively unknown given the paucity of published cases. We thus conducted a review of the literature to determine the state of current knowledge about DBS in pregnancy and to determine how eligibility criteria are approached in clinical trials with respect to pregnancy and the potential for pregnancy.
A literature review was conducted in EMBASE to identify articles involving DBS and pregnancy. Two reviewers independently analyzed the articles to confirm inclusion. Data extracted for analysis included conditions treated, complications at all stages of pregnancy, neonatal/pediatric outcomes, and DBS target. A second search was then conducted using www.clinicaltrials.gov. The same two reviewers then assessed whether each trial excluded pregnant individuals, lactating individuals, or persons of childbearing age planning to conceive. Also assessed was whether contraception had to be deemed adequate prior to enrollment.
The literature search returned 681 articles. Following independent analysis and agreement of two reviewers, 8 pregnancy related DBS articles were included for analysis. These articles described 27 subjects, 29 pregnancies (2 with subsequent pregnancies), and 31 infants (2 twin pregnancies). There was 1 preterm birth at 35 weeks, and 3 patients who experienced discomfort from the DBS battery (i.e., impulse generator) placement site. All 27 patients had a DBS device implanted before they became pregnant, which remained in use throughout their pregnancy. There was exclusion of pregnant individuals from 68% of 135 interventional trials involving DBS. Approximately 44% of these trials excluded persons of childbearing age not on "adequate contraception" or wishing to conceive in the coming years. Finally, 22% excluded breastfeeding persons.
The data from 29 pregnancies receiving DBS treatment during pregnancy was not associated with unexpected pregnancy or post-partum complication patterns. Many clinical trials have excluded pregnant individuals. Documentation of outcomes in larger numbers of pregnancies will help clarify the safety profile and will help guide study designs that will safely include pregnant patients.
深部脑刺激（DBS）越来越多地用于治疗各种神经和精神疾病的症状。人们在生育年龄期间可以接受该手术，但鉴于已发表的病例较少，DBS在孕期的安全性仍然相对未知。因此，我们对文献进行了综述，以确定关于孕期DBS的现有知识状况，并确定在临床试验中如何处理关于怀孕和怀孕可能性的纳入标准。
在EMBASE中进行文献综述，以识别涉及DBS和怀孕的文章。两名评审员独立分析文章以确认纳入情况。提取用于分析的数据包括治疗的疾病、孕期各阶段的并发症、新生儿/儿科结局以及DBS靶点。然后使用www.clinicaltrials.gov进行第二次检索。然后，同样的两名评审员评估每个试验是否排除了孕妇、哺乳期妇女或计划怀孕的育龄期人员。还评估了在入组前是否必须认为避孕措施充分。
文献检索返回681篇文章。经过两名评审员的独立分析和一致同意，纳入8篇与怀孕相关的DBS文章进行分析。这些文章描述了27名受试者、29次怀孕（2次后续怀孕）和31名婴儿（2次双胎怀孕）。有1例35周早产，3例患者因DBS电池（即脉冲发生器）植入部位感到不适。所有27例患者在怀孕前都植入了DBS装置，并且在整个孕期都在使用。在135项涉及DBS的干预试验中，68%排除了孕妇。这些试验中约44%排除了未采取“充分避孕措施”或希望在未来几年怀孕的育龄期人员。最后，22%排除了哺乳期妇女。
29例孕期接受DBS治疗的妊娠数据与意外怀孕或产后并发症模式无关。许多临床试验都排除了孕妇。记录更多妊娠的结局将有助于阐明安全性概况，并有助于指导安全纳入孕妇的研究设计。
