Physiological Changes Of Pregnancy Research Articles

Role of Granisetron in Reducing Spinal Anesthesia Induced Hypotension during Cesarean Section

Abstract Background Spinal anesthesia is the preferred method for elective cesarean sections due to considerable risks regarding airway management associated with physiological changes of pregnancy. Although it has been considered as a safe technique, spinal anesthesia has many side effects, including hypotension, bradycardia, nausea, and vomiting. Factors influencing the level and the intensity of block include the injected drug, the level of injection, the needle type, the patient position, and patient characteristics, such as age, height, weight, pregnancy, and spinal anatomy. Objective To evaluate the efficacy of different doses of granisetron, a 5-HT3 receptor inhibitors, on reducing the incidence of hypotension after subarachnoid block for cesarean section. Patients and Methods After obtaining approval from the Research Ethical Committee of Faculty of Medicine, Ain Shams University, and written informed consent this study was conducted in the operating theatres of Ain Shams University Hospitals. Results In our study we compared the effect of different doses of granisetron in reducing the hypotension occurring as a result of spinal anesthesia in parturients undergoing elective LSCS. The result of the study showed that compared to placebo group, there was a reduction in the degree of hypotension in group who was pre-medicated with IV grainsetron, and this reduction was more with increasing the dose of granisetron. Conclusion IV granisetron can be used as a pre-medication to reduce spinal anesthesia induced hypotension in parturients undergoing elective lower section cesarean section.

Cardiac Physiology and Pathophysiology in Pregnancy.

Cardiovascular disease is the leading indirect cause of maternal morbidity and mortality, accounting for nearly one third of maternal deaths during pregnancy. The burden of cardiovascular disease in pregnancy is increasing, as are the incidence of maternal morbidity and mortality. Normal physiologic adaptations to pregnancy, including increased cardiac output and plasma volume, may unmask cardiac conditions, exacerbate previously existing conditions or create de novo complications. It is important for care providers to understand the normal physiologic changes of pregnancy and how they may impact the care of patients with cardiovascular disease. This review outlines the physiologic adaptions during pregnancy and their pathologic implications for some of the more common cardiovascular conditions in pregnancy.

Fertility and Pregnancy after Bariatric Surgery: Challenges and Solutions

Abstract Introduction Obesity is increasing worldwide, and bariatric surgery (BS) is increasingly employed for weight management in women of reproductive age. An interplay between pregnancy and BS is very likely. A review of the challenges faced and solutions needed is warranted. Materials and Methods A narrative, nonsystematic review of the international literature from a single online database (PubMed) was performed on July 23, 2023. All articles were included. The retrieved relevant literature is narrated in a concise thematic account. Results BS carries major metabolic, mechanical, and vascular benefits, possibly accompanied by nutritional, vitamins, minerals, and micronutrient deficiencies, which might be clinical or subclinical. A few of the frequently reported postbariatric nutritional jeopardies could be augmented by the physiological changes of pregnancy, which need a different approach to management. Nutritional deficiencies during pregnancy could carry both maternal and fetal short- and long-term risks. Fetal risks may range from miscarriage to low birth weight, neural tube defects, congenital anomalies, cognitive impairment, and internal organ dysplasia. Postbariatric status is, by default, a high-risk pregnancy category, given the altered biochemical, vasomotor, and mechanical indices of any lady treated with BS. Postgastric bypass hypoglycemia (PGBH) is a relatively common phenomenon during pregnancy, and it usually calls for multidisciplinary action to control. A dedicated monitoring protocol before, during, and after pregnancy has been suggested in several guidelines to guard against the potentially devastating consequences to both mother and fetus. Conclusions Weight reduction after BS enhances fertility. The optimum timing for ladies treated with BS to get pregnant is not very well established yet. However, various societies have provided multidisciplinary management guidance of management prior to and during pregnancy. Many nutritional supplements that are not routinely prescribed during pregnancy will be essential for those treated with BS. Further studies are still warranted to ensure the safe interim between BS and conception as well as the safety of various doses of medications used for postbariatric individuals, for instance, medications used for PGBH.

Pregnancy with Non-cirrhotic Portal Hypertension: A Case Report

Pregnancy with non cirrhotic portal hypertension is an uncommon condition. Due to physiological changes in pregnancy, the patients with portal hypertension may exaggerate and produce life threatening complicationslike variceal haemorrhage and increased incidents of adverse maternal and fetal outcomes. Pregnancy also predisposes the patient to develop hepatic decompensation. So, management of such cases requires a multi-disciplinary approach. In this case report,21-year-old primigravida presented with known case of non cirrhotic portal hypertension at her 33 weeks of pregnancy with huge splenomegaly and history of hematemesis.The pregnancy ran uneventfully, and she underwent elective LSCS at 38+ weeks and gave birth of a live female baby, weighing 3kg was delivered. Post operative recovery was uneventful. The patient was discharged on the 4th post operative day. We want to focus upon different aspects of pregnancy with portal hypertensionto prevent complications and manage the case. J Rang Med Col. March 2024; Vol. 9, No. 1: 86-88

6287016 The physiological changes in pregnancy, a hazard?

6287016 The physiological changes in pregnancy, a hazard?

Cardiac evaluation in pregnant patients with dyspnea and palpitations

BackgroundSymptoms of underlying cardiac disease in pregnancy can often be mistaken for common complaints due to normal physiologic changes in pregnancy. Echocardiographic evaluation of patients with symptoms of palpitations and dyspnea can detect structural changes and identify high-risk features. ObjectiveThe study's objective was to examine transthoracic echocardiograms (TTEs) of perinatal individuals completed for palpitations or dyspnea to determine the frequency of identifying structural changes. Study DesignWe performed a retrospective cohort study of all perinatal individuals with a TTE at a single academic center between October 1, 2017, and May 1, 2022. The indication for the echocardiogram, demographics, and clinical characteristics were recorded. TTEs with any abnormal findings noted in the TTE report were reviewed and categorized into findings of congenital heart disease, valvular disease, pericardial effusion, evidence of ischemia/wall motion abnormalities, abnormal diastolic/systolic function, and other. ResultsOf our sample of 539 TTEs completed on 478 different individuals who were pregnant or in the 12-week post-partum period, 96 (17.8%) had an indication of palpitations and 32 (5.9%) were listed dyspnea as the indication. Abnormal findings were seen in 21.9% of patients with palpitations and in 34.4% of those with dyspnea. In the patients with palpitations who had abnormal findings, 33.3% had congenital heart disease, 33.3% had mild valvular disease including mitral valve prolapse, 19.0% had a pericardial effusion, and 14.3% had evidence of ischemia/wall motion defects. Abnormal TTE findings in the dyspnea cohort included ischemia/wall motion defects (27.3%), mild valvular disease or mitral valve prolapse (36.4%), and abnormal systolic/diastolic function (36.4%). ConclusionMany of the TTEs completed for patients with dyspnea or palpitations identified no structural abnormalities, however, in about one in three to one in four patients underlying structural heart disease was identified. While some of these abnormalities were unlikely to change delivery plans like mild valvular disease or small effusions, others such as ischemia, congenital abnormalities, and abnormal systolic/diastolic function were likely to have implications for pregnancy and post-partum management.

A detailed review of critical illness related to pregnancy

Critical illness during pregnancy refers to severe medical conditions that can endanger the health and life of the pregnant woman and the developing fetus. Using critical illness during pregnancy as a topic for a review article can provide valuable insights into the challenges, management strategies, and outcomes associated with high-risk pregnancies. Pregnancy is a unique and complex physiological state that can challenge obstetricians and intensivists. Despite the advances in prenatal care, certain critical pregnancy illnesses are associated with significant feto-maternal morbidity and mortality. Maternal complications arise from abnormalities in physiological changes of pregnancy. This section highlights the common yet severe pregnancy complexities, pathophysiology, clinical manifestations, diagnosis, and management in critical care settings to optimize maternal and fetal outcomes. Some of the frequently encountered critical pregnancy illnesses are preeclampsia, eclampsia, HELLP syndrome, amniotic fluid embolism, peripartum cardiomyopathy, placental abruption, postpartum hemorrhage, and ectopic pregnancy. Each condition is discussed separately, further insinuating the need for timely diagnosis and treatment. This article also reviews the current treatment strategies, including blood pressure management, supportive care, and surgical intervention in obstetric hemorrhage and rupture. Critical care in pregnancy warrants profound vigilance and an adept, intensive, multidisciplinary approach, as prompt recognition and intervention decrease mortality and carry lifelong implications for both the mother and child.

Anesthetic recommendations for maternal and fetal safety in nonobstetric surgery: a balancing act.

Nonobstetric surgery during pregnancy is associated with maternal and fetal risks. Several physiologic changes create unique challenges for anesthesiologists. This review highlights physiologic changes of pregnancy and presents clinical recommendations based on recent literature to guide anesthetic management for the pregnant patient undergoing nonobstetric surgery. Nearly every anesthetic technique has been safely used in pregnant patients. Although it is difficult to eliminate confounding factors, exposure to anesthetics could endanger fetal brain development. Perioperative fetal monitoring decisions require an obstetric consult based on anticipated maternal and fetal concerns. Given the limitations of fasting guidelines, bedside gastric ultrasound is useful in assessing aspiration risk in pregnant patients. Although there is concern about appropriateness of sugammadex for neuromuscular blockade reversal due its binding to progesterone, preliminary literature supports its safety. These recommendations will equip anesthesiologists to provide safe care for the pregnant patient and fetus undergoing nonobstetric surgery.

Validation of a noninvasive cardiac output monitor in maternal cardiac disease: comparison of NICOM and transthoracic echocardiogram

The physiological changes to the cardiovascular system during pregnancy are considerable and are more pronounced in those with cardiac disease. In the general population, noninvasive hemodynamic monitoring is a valid alternative to pulmonary artery catheterization, which poses risk in the pregnant population. There is limited data on noninvasive cardiac output monitoring in pregnancy as an alternative to pulmonary artery catheterization. We sought to compare transthoracic echocardiography with a noninvasive cardiac output monitor (NICOM, Cheetah Medical) in pregnant patients with and without cardiac disease. This was a prospective, open-label validation study that compared 2-dimensional transthoracic echocardiography with NICOM estimations of cardiac output in each trimester of pregnancy and the postpartum period. Participants with and without cardiac disease with a singleton gestation were included. NICOM estimations of cardiac output were derived from thoracic bioreactance and compared with 2-dimensional transthoracic echocardiography for both precision and accuracy. A mean percentage difference of ±30% between the 2 devices was considered acceptable agreement between the 2 measurement techniques. A total of 58 subjects were enrolled; 36 did not have cardiac disease and 22 had cardiac disease. Heart rate measurements between the 2 devices were strongly correlated in both groups, whereas stroke volume and cardiac output measurements showed weak correlation. When comparing the techniques, the NICOM device overestimated cardiac output in the control group in all trimesters and the postpartum period (mean percentage differences were 50.3%, 52.7%, 48.1%, and 51.0% in the first, second, and third trimesters and the postpartum period, respectively). In the group with cardiac disease, the mean percentage differences were 31.9%, 29.7%, 19.6%, and 35.2% for the respective timepoints. The NICOM device consistently overestimated cardiac output when compared with 2-dimensional transthoracic echocardiography at all timepoints in the control group and in the first trimester and postpartum period for the cardiovascular disease group. The physiological changes of pregnancy, specifically the mean chest circumference and total body water, may alter the accuracy of the cardiac output measurement by the NICOM device as they are currently estimated. Although NICOM has been validated for use in the critical care setting, there is insufficient data to support its use in pregnancy.

The Role of Antioxidants in Improving Pregnancy Outcomes

Pregnancy is a physiologically demanding phase marked by profound changes that elevate oxidative stress levels, posing potential risks to maternal and fetal health. Oxidative stress, resulting from an imbalance between reactive oxygen species (ROS) production and antioxidant defense mechanisms, has been implicated in various pregnancy complications. Antioxidants, renowned for their ability to counteract ROS and mitigate cellular damage, have emerged as a potential intervention to ameliorate adverse outcomes during pregnancy. The paper highlights the physiological changes in pregnancy that contribute to heightened oxidative stress, emphasizing the link between oxidative stress and complications such as pre-eclampsia, gestational diabetes, preterm birth, and intrauterine growth restriction. This paper emphasizes the imperative for robust, well-designed clinical trials to elucidate the optimal timing, dosages, and formulations of antioxidants in pregnancy. It calls for a comprehensive approach to establish clear guidelines and recommendations for antioxidant supplementation. In conclusion, this review underscores the potential of antioxidants as a promising intervention to mitigate oxidative stress-related pregnancy complications. However, the inconclusive nature of current evidence necessitates further rigorous research endeavors. Through this exploration, it accentuates the urgency for standardized protocols, ethical considerations, and extensive clinical studies to unlock the full potential of antioxidants in improving maternal and fetal health outcomes during pregnancy. Keywords: Antioxidants, Pregnancy, Maternal Health, Fetal Health, Oxidative Stress, Reactive Oxygen Species (ROS), Preeclampsia, Gestational Diabetes, Fetal Development

Successful Resuscitation of a Young Maternal Cardiac Arrest with Twin Pregnancy: A Case Report

Cardiopulmonary arrest in pregnancy is one of the most dreadful situations for clinicians. Along with physiological changes in pregnancy, the time constraint to save both lives makes this situation impeccably difficult to manage. Here, we present a case of successful resuscitation of a young mother with twin pregnancies who was diagnosed with pre-eclampsia and was under antihypertensive therapy for 4 days. Evidently, a multidisciplinary approach, rapid response and timely intervention can alleviate both the maternal and neonatal mortality rate in pregnancies landing up on cardiopulmonary resuscitation (CPR).

Striking the Balance: Bipolar Disorder in the Perinatal Period.

The authors reviewed the literature, published between 2018 and 2023, on treating bipolar disorder in the perinatal period in order to summarize current treatment perspectives. Mood episodes occur during pregnancy and there are high rates of both initial onset and recurrence in the postpartum period. Bipolar disorder itself is associated with higher risks of adverse pregnancy outcomes, including gestational hypertension, hemorrhage, cesarean delivery, and small for gestational age infants. A general principle of perinatal treatment includes maintaining psychiatric stability of the pregnant person while reducing medication exposure risk to the fetus. A variety of factors can compromise psychiatric stability, including rapid discontinuation of stabilizing medications, decreased efficacy due to physiologic changes of pregnancy, and exacerbation of underlying psychiatric illness. Psychosocial interventions include optimizing sleep, increasing support, and reducing stress. The American College of Obstetricians and Gynecologists recommends against discontinuing or withholding medications solely due to pregnancy or lactation status. Individualized treatment involves a discussion of the risks of undertreated bipolar disorder weighed against the risks of individual medication choice based on available evidence regarding congenital malformations, adverse neonatal and obstetrical events, and neurodevelopmental outcomes. Valproate is not a first-line treatment due to higher risks. Data are lacking on safety for many newer medications. The authors review current safety data regarding lithium, lamotrigine, and antipsychotics, which are the most commonly used treatments for managing bipolar disorder in the perinatal period. Due to physiologic changes during pregnancy, frequent therapeutic drug monitoring and dose adjustments are required.

Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics.

The treatment of cancer during pregnancy remains challenging with knowledge gaps in drug dosage, safety, and efficacy due to the under-representation of this population in clinical trials. Our aim was to investigate physiological changes reported in both pregnancy and cancer populations into a PBPK modeling framework that allows for a more accurate estimation of PK changes in pregnant patients with cancer. Paclitaxel and docetaxel were selected to validate a population model using clinical data from pregnant patients with cancer. The validated population model was subsequently used to predict the PK of acalabrutinib in pregnant patients with cancer. The Simcyp pregnancy population model reasonably predicted the PK of docetaxel in pregnant patients with cancer, while a modified model that included a 2.5-fold increase in CYP2C8 abundance, consistent with the increased expression during pregnancy, was needed to reasonably predict the PK of paclitaxel in pregnant patients with cancer. Changes in protein binding levels of patients with cancer had a minimal impact on the predicted clearance of paclitaxel and docetaxel. PBPK modeling predicted approximately 60% lower AUC and Cmax for acalabrutinib in pregnant versus non-pregnant patients with cancer. Our results suggest that PBPK modeling is a promising approach to investigate the effects of pregnancy and cancer on the PK of oncology drugs and potentially inform dosing for pregnant patients with cancer. Further evaluation and refinement of the population model are needed for pregnant patients with cancer with additional compounds and clinical PK data.

Fertility and pregnancy in adrenal insufficiency.

Despite the availability of adrenal hormone replacement therapy, patients with adrenal insufficiency can be affected by reduced fertility and parity. Patients with well-managed adrenal insufficiency are expected to have uneventful pregnancies and favourable outcomes, but an increased risk of maternal and neonatal complications has been reported in some cases. Many physiological changes occur to the hypothalamic-pituitary-adrenal (HPA) axis during pregnancy, often making a new diagnosis and management of adrenal insufficiency challenging. The management of adrenal insufficiency also needs to reflect the physiologic changes of pregnancy, often requiring increased doses of glucocorticoid as pregnancy progresses and in some circumstances mineralocorticoid replacement (in primary adrenal insufficiency patients only), especially in the third trimester. To date, there are no prospective data guiding management of adrenal insufficiency in pregnancy. In this review, we focus on the impact of adrenal insufficiency on fertility and parity based on the aetiology of adrenal insufficiency and provide a practical approach to the management of patients with adrenal insufficiency before and during pregnancy.

FRI629 A Mysterious Case Of Mother's Battle With Diabetic Ketoacidosis During Pregnancy

Abstract Disclosure: P.D. Sittirat: None. S.J. Choi: None. A. Gutierrez: None. M. Bashyam: None. Introduction: Changes in hormone regulatory mechanisms during pregnancy can increase the likelihood of diabetic ketoacidosis (DKA) in pregnant individuals. Despite the increased risk, the likelihood of DKA in pregnant individuals with diabetes mellitus is still low at around 0.5-3%. Management involves aggressive treatment following standard DKA protocols. We delve into a mysterious case of DKA in the second trimester of pregnancy. Case Presentation: A 31-year-old G1P0 woman at 24 weeks gestation with no past medical history presented with nausea, constipation associated with back and abdominal pain. Admission labs were significant for blood glucose 369 mg/dL, CO2 11 meq/L, anion gap 19 mEq/L, white blood cell 17.2 K/uL, HbA1c 9.5%, and serum ketones 3.9 mmol/L. Within 12 hours of admission into the intensive care unit for DKA, the patient was at 5-6 cm cervical dilation without signs of fetal distress. The newborn was delivered prematurely with complications of retinopathy and patent ductus arteriosus. Mother's lab studies showed negative for anti-GAD antibody, insulinoma associated 2 autoantibodies, islet cell antibody, and zinc transporter 8 antibody. C-peptide was low at 0.9 ng/mL (normal range 1.1 to 5.5 ng/mL). The patient was maintained on subcutaneous insulin which eventually tapered off at 2 months post-partum due to hypoglycemia. At 4 and 11-month follow-ups, her HbA1C was 5.8% and 5.5%, respectively. Her blood glucose was well controlled with a regular diet. She did get post-prandial spikes with a high carbohydrate diet. Discussion: Physiological changes in pregnancy make pregnant individuals more susceptible to DKA. Even so, the likelihood of DKA in pregnancy is rare. It is even rarer to have a new diagnosis of diabetes leading to DKA in pregnancy just before evaluation at the standard 28 weeks like the events precipitated in this case. DKA in pregnancy puts both the mother and fetus at risk for long-term complications. The maternal mortality rate in pregnancy with DKA is 5% to 15%, while the fetal mortality rate is 30% to 90%. The patient’s demographic background of being a young Caucasian, thin woman who presented with a new onset DKA and had a low C-peptide was more consistent with type 1 diabetes; however, all her antibodies were normal. It’s questionable if this patient has autoantibody negative new onset type 1 diabetes and is currently in remission. It's worth to mention that she had a history of mild Covid-19 infection at 8 weeks gestation but this new onset DKA developed at 24 weeks gestation. The chance of gestational diabetes was low due to low c-peptide on presentation. Annual follow-up of the patient is necessary to monitor her HbA1C while she is off diabetes medications. Presentation: Friday, June 16, 2023

An obstetric-specific surgical Apgar score predicts maternal morbidity from cesarean hysterectomy for placenta accreta spectrum.

Placenta accreta spectrum (PAS) is a continuum of placental conditions characterized by significant maternal and neonatal morbidity. Tools to accurately predict postoperative morbidity have been lacking due to the hemodynamic changes of pregnancy. The surgical Apgar score (SAS) is a 10-point scale that assesses heart rate, mean arterial pressure, and estimated blood loss. The SAS has been validated to predict morbidity such as blood transfusion and reoperation. We created an obstetric-specific SAS (ObSAS) scale for physiologic changes of pregnancy (two-fold increase in blood loss, 10% increased heart rate, and 5% decreased mean arterial pressure) and analyzed 110 cases of PAS who underwent cesarean hysterectomy. An ObSAS of 0-4 (poorest score) was significantly associated with increased risk of intensive care unit (ICU) admission (odds ratio [OR] 40.6, 95% confidence interval [CI] 7.9-742.9), transfusion >4 units (26/26 patients), and greater surgical morbidity (OR 22.7, 95% CI 4.4-415.0). ObSAS of 9-10 resulted in no ICU admissions (0/12), fewer blood transfusions (OR 0.1, 95% CI 0.1-0.4). and less surgical morbidity (OR 0.09, 95% CI 0.01-0.37). Given the overall surgical morbidity associated with PAS cesarean hysterectomy, the ObSAS score is a powerful tool with excellent predictive capabilities for ICU admission, blood transfusion, and surgical morbidity, allowing for resource allocation, prophylactic interventions, and optimal patient outcomes.

ST-Segment Elevation Myocardial Infarction (STEMI) of Atherosclerotic Etiology in a Pregnant Woman

During pregnancy, it is not expected for pregnant women to experience a heart attack, considering their age group and the incidence of comorbidities in this population. However, we should always be mindful of relevant precautions because, although rare, a heart attack can indeed occur in pregnant women. The classic symptom of a heart attack is chest pain, and it is not uncommon to face diagnostic challenges since numerous more common conditions during pregnancy can mimic this symptom, such as reflux, anxiety, and musculoskeletal pain. If a pregnant woman experiences any episode of chest pain during pregnancy, clinical evaluation is necessary, bearing in mind that although rare, it is among the possible types of heart attacks. The treatment of a heart attack during pregnancy is extremely complex due to the scarcity of clinical data, challenges in drug management, and the physiological changes of pregnancy, as well as the stress of child birth leading to an increase in cardiac effort. Adequate prenatal care and support from referral hospital scan make a difference. In this report, we present a case of a pregnant patient with ST-segment Elevation Myocardial Infarction (STEMI).

The Effect of Volume Preload versus Ephedrine Infusion for Prevention of Hypotension due to Spinal Anesthesia for Cesarean Section

Abstract Background Spinal anesthesia is the preferred method for elective cesarean sections due to considerable risks regarding airway management associated with physiological changes of pregnancy. We hypothesized that using ephedrine to maintain maternal blood pressure during spinal anesthesia for cesarean delivery provides better hemodynamic stability with subsequent better maternal and neonatal outcomes compared to volume preload. Aim of the Work We compared volume preload and ephedrine infusion to guard against the hypotensive effect of spinal anesthesia during cesarean delivery. Patients and Methods After obtaining approval from the Research Ethical Committee of Faculty of Medicine, Ain Shams University, and written informed consent this study was conducted in the operating theaters of Ain Shams University Hospitals. This study was a randomized Controlled Clinical Trial. Adult parturients undergoing cesarean section under spinal anesthesia randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: Group (A) received Volume Preload, group (B) received Ephedrine Infusion. Results The results of the study showed that compared with volume preload, ephedrine maintained maternal blood pressure and uterine artery blood flow. Further, it was associated with lower numbers of hypotension and hypertension episodes and less frequency of bradycardia and tachycardia during cesarean delivery. Conclusion Furthermore, the numbers of boluses of vasopressors used during spinal anesthesia were lower in ephedrine compared with volume preload.

Physiological Changes in Mother During Pregnancy that Impact on the Pharmacokinetics and Pharmacodynamic of Drug: Literature Review

Physiological changes occurring during pregnancy can affect drug pharmacodynamics and pharmacokinetics, leading to decreased or increased drug disposition. This research uses a systematic review method or literature review. The analysis was carried out by collecting data that met the requirements and filtering based on the suitability of the article title with the research objectives to obtain relevant articles after going through the filtering stage to data extraction. The results showed that physiological changes in pregnancy induce major changes in the pharmacokinetic properties of many drugs. These changes affect the distribution, absorption, metabolism, and excretion of drugs, and thus may affect their pharmacodynamic properties during pregnancy.

Protected from harm, harmed by protection: ethical consequences of the exclusion of pregnant participants from clinical trials

Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it’s own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children.