Evaluating The Safety And Effectiveness Of Gastric Electrical Stimulation

Journal of Clinical Obstetrics and Gynecology Research Evaluating The Safety And Effectiveness Of Gastric Electrical Stimulation (GES) In Patients With Severe Gastroparesis During Pregnancy. *Corresponding Author: Dr. Siriwardana HP Priyantha. Department of Surgery, Mid and South Essex NHS Foundation Trust, Broomfield Hospital, Essex, UK, CM1 7ET. Email: [email protected]. Received: 02-Dec-2025, Manuscript No. JOCOGR - 5294 ; Editor Assigned: 03-Dec-2025 ; Reviewed: 22-Dec-2025, QC No. JOCOGR - 5294 ; Published: 27-Feb-2026.DOI: 10.52338/jocogr.2026.5294. Citation: Dr. Siriwardana HP Priyantha. Evaluating The Safety And Effectiveness Of Gastric Electrical Stimulation (GES) In Patients With Severe Gastroparesis During Pregnancy. Journal of Clinical Obstetrics and Gynecology Research. 2026 February; 15(1). doi: 10.52338/jocogr.2026.5294. Copyright © 2026 Dr. Siriwardana HP Priyantha. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ISSN 2766-2756 Research Article Alan Askari 1 , HP Priyantha Siriwardana 2 , Ali Kordzadeh 2 , Esturo Yazaki 2 , Sritharan Kadirkamanathan 2 1. Department of General Surgery, Bedfordshire Hospitals NHS Foundation Trust, Lewsey Rod, Luton, Bedfordshire, LU4 0DZ. 2. Department of Surgery, Mid and South Essex NHS Foundation Trust, Broomfield Hospital, Essex, UK, CM1 7ET. www.directivepublications.org Abstract Introduction: Gastroparesis presents a significant challenge in pregnancy, affecting maternal and foetal health. This paper examines the safety and efficacy of Gastric Electrical Stimulation (GES) as a therapeutic modality in pregnant patients with gastroparesis. Materials & Methods: A retrospective analysis was conducted on pregnant patients with in-situ GES identified from our gastroparesis patient database. We evaluated the safety and efficacy of GES during pregnancy, focusing on Quality of Life (QoL) improvements and symptom control. Key metrics included QoL SF36 scores, and the severity of nausea, vomiting, pain, satiety, and bloating. Hospital stay lengths, admission frequency, and the need for feeding support were also assessed both pre- and post-operatively. Results: The study included twelve pregnant women with in-situ GES. The median age at surgery was 29 years (Interquartile Range [IQR]: 26-31 years), with 58% of the patients having diabetes-induced gastroparesis. Robotic GES insertion was performed in 75% of cases. Post- operatively, significant improvements were observed in nausea score (reduced from 4 to 1), vomiting score (from 4 to 0), pain score (from 4 to 1), satiety score (from 4 to 0), and bloating score (from 4 to 0). SF36 scores improved significantly, increasing from a median pre-operative score of 261 (IQR: 178-65) to 1,783 (IQR: 765-3,527, p<0.001). Additionally, 58% of patients transitioned from assisted to independent feeding. Conclusion: Gastric Electrical Stimulation appears to be a safe and effective treatment modality for gastroparesis in pregnant patients, significantly improving symptoms and QoL. Further extensive research is warranted to validate these findings and explore the broader implications of GES in the management of pregnancy-associated gastroparesis. Keywords: pregnancy, gastroparesis, Gastric Electrical Stimulator (GES). INTRODUCTION Gastroparesis is a chronic neuromuscular disorder character- ised by delayed gastric emptying in the absence of mechan- ical obstruction. It presents with debilitating gastrointestinal symptoms such as nausea, vomiting, early satiety, bloating, and epigastric discomfort—each of which significantly impairs quality of life and nutritional status 1 . Although gastroparesis affects individuals of all genders, its prevalence is notably higher among women, particularly during their reproductive years 2 . This increased incidence among women of childbear- ing age renders the intersection of gastroparesis and preg- nancy both clinically significant and complex. Managing gastroparesis during pregnancy presents distinct challenges. Pharmacological options commonly used to treat gastroparesis—such as dopamine receptor antagonists, mac- rolide antibiotics, and serotonin receptor agonists—are as- sociated with potential teratogenic risks and have not been extensively validated in pregnant populations. Non-pharma- cological strategies, including dietary modifications and be- havioural interventions, may provide some symptom relief but their efficacy is variable 3 . These limitations are further compounded by the physiological changes of pregnancy, such as altered gastrointestinal motility and hormonal influ- ences, which can exacerbate symptoms and complicate man- agement 4 . Gastric Electrical Stimulation (GES) has emerged as a prom- ising therapeutic option for refractory gastroparesis. It has demonstrated efficacy in improving gastric motility and re- ducing symptoms such as nausea and vomiting. 5 However,

Directive Publications Dr. Siriwardana HP Priyantha the safety and effectiveness of GES in pregnancy remain poor- ly characterised, with limited data available. A small case se- ries by Soliman and colleagues published in 2023 represents one of the few contributions examining maternal and foetal outcomes in this context 6 . Given the sparse and fragmented nature of existing research, this study aims to retrospectively evaluate the safety and clin- ical effectiveness of GES in pregnant patients with severe gas- troparesis. We explore symptom control, nutritional support requirements, and maternal-foetal outcomes, with the broad- er objective of informing best clinical practices and guiding future research in this underexplored domain. MATERIALS & METHODS Study Design and Population This retrospective study was conducted on a cohort of preg- nant patients (with proven Gastroparesis) who had previously undergone Gastric Electrical Stimulation (GES) implantation. We included patients from December 2000 to June 2021, identified from our comprehensive gastroparesis patient da- tabase. The study aimed to evaluate the safety and efficacy of GES during pregnancy, with a specific focus on Quality of Life (QoL) improvements and symptom control.

Data Collection Prospective data were collected on all patients undergoing GES insertion within the specified timeframe. This included detailed patient demographics, disease aetiology, and a com- prehensive record of symptoms such as nausea, vomiting, bloating, early satiety and abdominal pain. The severity of these symptoms was quantitatively assessed using a Likert scale both pre and post GES insertion. Additionally, the SF-36 questionnaire, a standardised tool for measuring health-re- lated quality of life, was completed by patients prior to GES insertion and then at regular intervals of 6 to 18 months post-surgery.

Outcome Measures The primary outcome measures were changes in the QoL, as reflected in the SF-36 scores, and the severity of gastropare- sis-related symptoms. We also meticulously recorded patient weight before and after GES insertion to monitor any signifi- cant changes. Hospital records were reviewed to gather data on the number of hospital admissions and the duration of hospital stays attributed to gastroparesis symptoms, both be- fore and after the insertion of the GES device.

Additional Data Analysis Information regarding the patients’ feeding regimes was also collated. This included details on the type of feeding support required, such as enteral feeding or total parenteral nutrition, and any changes in these requirements following GES inser- tion. The analysis of these data aimed to provide a compre- hensive understanding of the impact of GES on the manage- ment of gastroparesis in pregnant patients, assessing both the physical health outcomes and the overall improvement in the patients' quality of life. Statistical Analysis Different methods were employed for the statistical evalua- tion of outcomes based on the nature of the data. Parametric data were analysed using the Student's t-test, which is suit- able for comparing means of two groups. For non-paramet- ric data, which do not assume a normal distribution, the Wil- coxon test was utilized to assess the differences. This test is particularly useful for comparing the median values of two related samples. In the case of binomial data, mar’s test was applied. This test is specifically designed for paired nominal data to determine if there are differences in the proportions between two related groups. All statistical analyses were performed using the latest version of IBM® SPSS® Statistics (v28.0), a comprehensive software package widely used for data management and statistical analysis in social science and medical research. RESULTS The cohort for this study comprised twelve women with GES in situ (Table 1) who became pregnant (14 pregnancies in 12 patients; n=10 had 1 pregnancy and two patients had two pregnancies each). The median age at the time of GES inser- tion was 29 years (IQR: 26-31 years). Most of these patients, 58.3%, were diagnosed with diabetic gastroparesis. The oper- ative approach for GES insertion was predominantly robotic, utilised in 75% of the cases. Table 1. Demographics of patients with a Gastric Electrical Stimulator (GES) in situ for refractor gastroparesis who be- came pregnant during their treatment. n % Age at GES insertion <30 years 30+ years 7 5 58.3% 41.7% Gastroparesis Type Diabetic Idiopathic 7 5 58.3% 41.7% Number of Pregnancies 1 2 10 2 83.3% 16.7% Operative Approach Open Robotic 3 9 25.0% 75.0% Post-surgical evaluations revealed marked improvements across several metrics (Table 2). The nausea score experi- enced a substantial reduction, decreasing from an average of 4 to 0.5 (p=0.004). There was a notable decrease in the vomit- Page - 2Open Access, Volume 15 , 2026

Dr. Siriwardana HP Priyantha Directive Publications ing score, which dropped from 3.4 to 1.0 (p=0.011), and the pain score similarly improved from 1.8 to 0.3 (p=0.039). Improve- ments were also seen in the satiety and bloating scores, with decreases from 2.4 to 0.7 (p=0.026) and from 2.7 to 0.4 (p=0.010), respectively. The number of hospital admissions post GES insertion showed a non-significant reduction from an average (mean or median) of 2.8 to 0.0 (p=0.066). Regarding the SF-36 Quality of Life Score, there was a significant increase, indicating an enhanced quality of life post-surgery; the score rose from a median of 261 pre-operatively to 1783 post-operatively. Table 2. Comparison in weight and mean symptom scores pre and post surgery (higher symptom scores correlate with worse symptoms). Mean Pre GES Post GES p Weight (kg) 64.7 69.7 0.655 Nausea Hours Per Day 15.2 3.7 0.048 Nausea Score 4.0 0.5 0.004 Vomiting Episodes Per Day 4.4 2.8 0.102 Vomiting Score 3.4 1.0 0.011 Pain Score 1.8 0.3 0.039 Satiety Score 2.4 0.7 0.026 Bloating Score 2.7 0.4 0.010 Days in Hospital 21.1 0.0 0.038 Page - 3Open Access, Volume 15 , 2026 The average body weight of the patients saw a non-significant increase from 64.7 kg before GES insertion to 69.7 kg after the procedure (p=0.655). The number of nausea hours per day was significantly reduced from 15.2 to 3.7 (p=0.048). Further- more, the length of hospital stay due to gastroparesis symp- toms showed a significant decline, with patients not requiring hospitalisation post GES insertion compared to an average of 21.1 days before the procedure (p=0.038). Importantly, all the women carried their pregnancies to full term with no compli- cations encountered by the mother or the child. DISCUSSION The salient outcomes of our study demonstrate that the use of GES in pregnant patients with gastroparesis is both safe and effective. All pregnancies in the study culminated in live births without any maternal or foetal mortalities, and nota- bly, there were no device-related complications. This suggests that GES can be a viable treatment for managing gastropa- resis symptoms during pregnancy, potentially improving the quality of life for expectant mothers suffering from this con- dition. The challenge of diagnosing and managing gastroparesis is considerable, compounded by its poor understanding of its pathophysiology and the limited efficacy of existing treat- ments. The literature on this subject, particularly during pregnancy, is notably scant. Our study enriches the sparse data available, methodically documenting the pregnancy out- comes of women undergoing GES treatment for gastropare- sis. This research marks a pioneering step, especially when considered against the backdrop of the only other known case series—a collection of 12 patients from France reported by Soliman 6 . Addressing severe gastroparesis therapeutically is particular- ly arduous, mainly as resultant of the fact that the pathophys- iology of gastroparesis remains poorly understood 2 . Current medical interventions frequently fall short of providing sig- nificant relief 1 , this is even more acute for pregnant patients. Over the last fifty years, substantial efforts have been direct- ed towards pioneering treatments that can normalise gastric myoelectrical activity. GES, especially the high-frequency/ low-energy variant with brief pulses, has shown promise, not only in symptom management but also in enhancing patient well-being 7 . The efficacy of GES is thought to reach beyond the alleviation of symptoms; it may also activate ghrelin secretion 8,9 , which plays a critical role in satiety and gastrointestinal motility. This mechanism could elucidate the observed improvements in gastric emptying in some and patient satiety. Compre- hensive reviews and extended studies have affirmed GES's significant influence on the gastric emptying of both liquids and solids, with long-term safety and sustained control over symptoms 10–12 . These insights also shed light on the additional advantages of GES, such as enhanced body mass index, se- rum albumin concentration, and blood sugar regulation 13,14 . Our findings reveal no notable increase in pregnancy-asso- ciated maternal complications within the cohort, bolstering the view of GES as a viable treatment during pregnancy. Fur- thermore, the manifestation of gastrointestinal symptoms frequently mirrored physiological changes in pregnancy, ren- dering it difficult to distinguish between symptoms caused by gastroparesis and those typically experienced during gesta- tion. Maintaining GES throughout pregnancy has thus been validated as a judicious strategy to manage chronic vomiting symptoms, corroborating its safety for both the mother and the unborn child.

Dr. Siriwardana HP Priyantha Directive Publications CONCLUSION In summary despite the retrospective nature of our study and the inherent potential for recall bias, it offers invaluable in- sights into the management of gastroparesis in the context of pregnancy. It lays the groundwork for future inquiries and re- assures the medical community about the applicability of GES for pregnant individuals. To fortify these preliminary findings and refine gastroparesis treatment protocols during preg- nancy, further research with more extensive patient groups is imperative.

Ethics Ethical approval has been obtained from and the study has been registered with the Mid & South Essex NHS Foundation Trust’s Research Department Registration number GSURG223 Conflict of Interest All authors declare no conflict of interests Author Contributions The authors have contributed to this study in the following ways: Study Design: Alan Askari, Priyantha Siriwardana Sritharan Kadirkamanathan Data Acquisition: Alan Askari, Priyantha Siriwardana, Ali Kordzadeh, Esturo Yazaki Data Analysis & Interpretation: Alan Askari, Priyantha Siri- wardana,, Sritharan Kadirkamanathan Manuscript Preparation: Alan Askari, Priyantha Siriward- ana, Ali Kordzadeh Manuscript Editing: Sritharan Kadirkamanathan, Priyantha Siriwardana. REFERENCES 1. Grover, M., Farrugia, G. & Stanghellini, V. Gastroparesis: a turning point in understanding and treatment. Gut 68, 2238–2250 (2019). 2. Camilleri, M. & Sanders, K. M. Gastroparesis. Gastroenterology 162, 68-87.e1 (2022). 3. Eseonu, D. et al. Dietary Interventions for Gastroparesis: A Systematic Review. Adv Nutr 13, 1715–1724 (2022). 4. Moosavi, S., Min, Y. W., Wong, M. & Rezaie, A. Gastroparesis in pregnancy. Am J Obstet Gynecol 228, 382–394 (2023). 5. Shanker, A., Bashashati, M. & Rezaie, A. Gastric Electrical Stimulation for Treatment of Refractory Gastroparesis: the Current Approach to Management. Curr Gastroenterol Rep 23, 2 (2021). 6. Soliman, H., Schalla, M. A., Coffin, B. & Gourcerol, G. Gastric electrical stimulation is safe during pregnancy and delivery: Results from a French cohort. Neurogastroenterol Motil 35, e14657 (2023). 7. Medical Advisory Secretariat. Gastric electrical stimulation: an evidence-based analysis. Ont Health Technol Assess Ser 6, 1–79 (2006). 8. Gallas, S. & Fetissov, S. O. Ghrelin, appetite and gastric electrical stimulation. Peptides 32, 2283–2289 (2011). 9. Gallas, S. et al. Gastric electrical stimulation increases ghrelin production and inhibits catecholaminergic brainstem neurons in rats. Eur J Neurosci 33, 276–284 (2011). 10. Marowski, S. et al. Both gastric electrical stimulation and pyloric surgery offer long-term symptom improvement in patients with gastroparesis. Surg Endosc 35, 4794– 4804 (2021). 11. Lal, N., Livemore, S., Dunne, D. & Khan, I. Gastric Electrical Stimulation with the Enterra System: A Systematic Review. Gastroenterol Res Pract 2015, 762972 (2015). 12. Gourcerol, G. et al. Gastric electrical stimulation versus per-oral pyloromyotomy for the treatment of nausea and vomiting associated with gastroparesis: An observational study of two cohorts. Neurogastroenterol Motil 35, e14565 (2023). 13. Setya, A., Nair, P. & Cheng, S. X. Gastric electrical stimulation: An emerging therapy for children with intractable gastroparesis. World J Gastroenterol 25, 6880–6889 (2019). 14. Abell, T. et al. Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate, and long-term follow-up. JPEN J Parenter Enteral Nutr 27, 277–281 (2003). Page - 4Open Access, Volume 15 , 2026

This is an automatically generated text version. For the formatted version of record, download the PDF →