Pregnancy Category Research Articles

Investigating Cesarean Section Trends: A Study Using the Modified Robson Classification in a Tertiary Care Setting.

The cesarean section (CS) rate is steadily rising in developed and developing nations. While CS is often perceived as a life-saving intervention, it comes with associated dangers for both the presentand future pregnancies. The Robson criteria classify CS into 10 groups with further sub-divisions based on the gestational age, various pregnancy categories, prior obstetrical records, and the progress of labor and delivery. This retrospective record review was conducted at Aga Khan University Hospital in Karachi, Pakistan. A non-probability consecutive sampling method was employed to enroll all 1198 pregnant women who underwent CS delivery between July 1st and December 31st, 2022. A total of 2616 deliveries were performed during the study period; among these, 1198 (45%) were delivered by CS. Out of 10 groups of Robson Criteria, Group 5 emerged as the primary contributor to the overall CS rate, making up approximately 34.3% of cases, followed by Group 10, which contributed to28.5% of cases. Group 2 contributed 16.4% of cases in total, with subgroup 2A constituting 12% of the overall rates, and Group 1 was found to be the fourth contributing category (5.1%), succeeded by Group 6 (4.9%), Group 4 (3.9%), and Group 8 (3.4%). The Modified Robson Criteria was foundto be an effective and easy-to-comprehend tool, which assists in monitoring the indications of CS and aids in devising strategies to reduce itsrates in clinical practice.

Challenges to Contraceptive Counseling With Isotretinoin Treatment and Future Directions for Dermatologists

Accutane, also known as isotretinoin, is an oral systemic retinoid utilized in the treatment of severe, treatment-resistant acne. Isotretinoin is a pregnancy category X drug, meaning that studies have documented congenital defects in pregnant patients on isotretinoin. Known abnormalities include ear abnormalities, facial dysmorphia, cleft palate, CNS abnormalities, thymus gland abnormalities, and parathyroid hormone deficiencies. With teratogenicity well-documented with isotretinoin use, the iPLEDGE system was created to educate prescribers, pharmacists, and patients about the risks of isotretinoin use. Utilizing iPLEDGE, individuals of child bearing potential (ICBP) are required to document two negative pregnancy tests before the initiation of isotretinoin therapy with two documented forms of birth control. We conducted a literature review utilizing the terms: accutane, isotretinoin, contraception, and birth control. We found that amongst multiple articles, the most popular primary contraceptive methods in iPLEDGE were abstinence (47% of users) and combined oral contraceptives (31% of users). Individuals have attributed their lack of contraceptive use to fear of birth control health impacts and belief in the equivalent effectiveness of non-accepted methods (e.g. withdrawal and natural family planning. Despite the establishment of iPLEDGE to systematically reinforce counseling requirements, the incidence of isotretinoin-exposed pregnancies continues to persist with approximately 100-200 pregnancies annually. Given these findings, it is clear that counseling is tantamount to dispelling misconceptions regarding contraception and optimizing rates of patient compliance. Despite this importance, counseling remains a large issue for dermatologists. Only half of board-certified dermatology residents surveyed in 2023 felt comfortable providing counseling on adverse effects of combined oral contraceptives (COCs), and only 38.8% felt comfortable providing counseling directions for COCs. Solutions for this include quickly accessing a referral to primary care or OB/GYN and potentially new avenues that are more easily accessible such as the progestin-only oral contraceptive pill that was recently approved for over the counter use by the United States Food and Drug Administration.

Assessment of knowledge of the new pregnancy and lactation labeling rule among pharmacists and physicians in Saudi Arabia.

Researchers in Saudi Arabia conducted this study to determine the level of familiarity that pharmacists and physicians possess with the pregnancy and lactation labeling rules established by the Food and Drug Administration. The present study included a cross-sectional survey conducted among pharmacists and physicians working in Saudi Arabia. The sample size was determined using the Rao sample size calculator. We utilized the Statistical Package for the Social Sciences (SPSS) version 25 for our analysis. A total of 122 respondents completed the study. Among them, 72.9% were aged between 25 and 44 years, and approximately 63.9% were male. About 64% of the respondents indicated familiarity with the A, B, C, D, and X letter system of pregnancy category labeling. Over 37% stated that the new pregnancy and lactation labeling rule would continue to use the lettering system. Additionally, 83% believed that the A, B, C, D, and X risk category labeling system is a useful resource, and 82% believed that working with this risk category labeling improves patient care. The study revealed that pharmacists and physicians exhibited good knowledge of the old rule but a low level of knowledge regarding the new rule. Despite significant flaws in the old system, most preferred it. Enhancing knowledge in this area is crucial for improving risk communication and the quality of care for women of reproductive age.

Effect of high-risk pregnancy on prenatal stress level: a prospective case-control study

The study aimed to determine the effects of high-risk pregnancy on prenatal stress levels. The study was conducted with a case-control design in Turkey in September-December 2019. The sample included pregnant women diagnosed with high-risk pregnancy and were at their 36th or later gestational weeks as the case group (n = 121) and healthy pregnant women as the control group (n = 245). The Antenatal Perceived Stress Inventory (APSI) and the Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) were used to assess the stress levels of the participants in the study. It was determined that high-risk pregnancy was associated with higher rates of prenatal stress (APSI: p < 0.001, effect size = 0.388; NUPDQ: p = 0.002, effect size = 0.272) compared to the control group. The results of the linear regression analysis showed that high-risk pregnancy affected APSI (R2 = 0.043, p < 0.001) and NUPDQ (R2 = 0.033, p = 0.009) scores, but education levels, number of pregnancies, and number of abortions did not affect APSI and NUPDQ scores. According to the results of this study, high-risk pregnant women are in a risk group for stress. It is of great importance for the course of a pregnancy that healthcare professionals assess the stress levels of pregnant women in the high-risk pregnancy category and provide psychological support to pregnant women who have high stress levels or are hospitalized.

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.

P017 Planned infliximab use during pregnancy for pakistani patients with immune-mediated inflammatory disease - case series of 12 patients

Abstract Background/Aims Immune-mediated inflammatory diseases (IMIDs) affect mostly young females during their reproductive age. Therefore, a better understanding is needed about the possible disease effects in pregnancy, as well as the risks of fetal exposure to the medications used. Studies have shown that anti-TNF are considered safe and do not increase the risk of adverse events during pregnancy. Nevertheless, the data is quite limited, hence fall in FDA pregnancy category B. We wish to report a series of 12 pregnant women with IMIDs who were intentionally being treated with infliximab for the treatment of active intractable IMIDs. Methods The study included pregnant patients with IMIDs who were treated using anti-TNF between January 2021 to July 2023 at Fatima Memorial Hospital and Doctors Hospital &amp; Medical Centre, Lahore. All patients receiving infliximab were reviewed by a dedicated medical team, who maintained a detailed medical record of each visit. The patients were prospectively followed up and the neonatal outcome was also recorded. Results 12 pregnant women with IMIDs received Infliximab during this study. All these patients required &amp;gt;7.5mg of deltacortil to control their arthritis and hence decision was made to add bDMARDs. 10 patients successfully completed their pregnancies uneventfully and two additional patients are in the later stages of pregnancy. Seven patients had complete remission of their underlying IMIDs and the rest had overall good improvement but continued to have low grade active disease. All our patients presented a satisfactory response to treatment and the pregnancy progressed without any complications. Median gestational week of birth was 38 with a median birth weight of 3490 grams. Conclusion This is the first reported series from Pakistan of intentional infliximab use throughout pregnancy. Our data, combined with many other studies, suggests that anti-TNF is safe during pregnancy and its benefits in achieving control of IMIDs may outweigh the risk of foetal exposure to the drug. This is further supported by the available data suggesting the inflammatory activity as the main risk factor for unfavourable outcome. However, the benefits and risks must be discussed with the patient and management decisions should be taken on individual basis. Disclosure Z. Tayyab: None. M. Haroon: None.

Dermatologic drug safety in lactation

In 2014, the US FDA removed the Pregnancy Category Drug lettering system and enacted the “Pregnancy and Lactation Label Ruling.” This ruling required drug products to contain contact information for drug-specific exposure pregnancy registries, narrative-style sections summarizing the known effect of pregnancy, lactation counseling data, and data describing risks for females and males of reproductive potential. This new ruling has added more dialogue and discussion to the patient-provider decision-making process and requires clinicians to provide more individualized counseling based on the current medical literature. This article summarizes the recent evidence for the safety of the most common dermatological therapies for pregnant and lactating women.

Prescribing Drugs to Pregnant Women in Primary Healthcare

It is crucial for the health of both the mother and the fetus that drugs are only used during pregnancy when absolutely necessary. While appropriate drugs can be used for appropriate indications during pregnancy, it is preferably recommended not to use medication except for the necessary vitamins. In cases where the drug is to be used, the pregnancy category of the medication to be used should be known for the selection of the appropriate medication. Drugs that we regularly prescribe because they are safe should be high on our list of preferences, and if there is chronic drug use, the use of drugs must be regulated with caution and constantly reviewed for appropriateness.

Patterns, Potential Teratogenicity, and Associated Factors of Drugs Prescribed to Pregnant Women Attending Antenatal Care Units in Debre Tabor Comprehensive Specialized Hospital, Debre Tabor, Northwest Ethiopia

Background: About 80% of pregnant women use at least one medication during their pregnancy period. Many drugs that are not allowed to be used during pregnancy (from FDA Pregnancy Categories D and X) were used. Irrational use of these drugs during pregnancy may result in different birth defects, as explained by thalidomide and diethylstilbestrol’s tragedy. Knowledge of drug utilization and associated factors that affect the pattern is important to enhance rational prescribing. But information about prescription patterns and associated factors among pregnant women is scarce in the Debre Tabor area and generally in Ethiopia.Objective: This study was aimed at assessing drug prescription patterns, potential teratogenicity, and associated factors among pregnant women attending the antenatal care unit at Debre Tabor Comprehensive Specialized Hospital, Debre Tabor, Northwest Ethiopia.Methods: A retrospective cross‐sectional study design was performed on 359 pregnant women attending antenatal care units from June 01, 2022, to August 30, 2022, in the hospital. Necessary data were obtained through a questionnaire by reviewing the medical charts of the women. Analysis of the data was performed using SPSS Version 23. The association of the independent variables to medication use was assessed using multivariate logistic regression. A p value of less than 0.05 was considered significant.Results: Most of the study participants (325/359) were married (90.5%). From a total of 359 participants, 350 (97.5%) were prescribed with drugs. About 64% (385/602) of the prescribed medications were iron and vitamins. The most commonly prescribed medications are iron and folic acid combination (340/602, 56.5%), albendazole (48/602, 8%), mebendazole (37/602, 6.1%), omeprazole (33/602, 5.5%), followed by amoxicillin (32/602, 5.3%). The majority (79.3%) of the drugs were from FDA Pregnancy Categories A and B. Prescribed drug utilization was more probable in women who first visited the facility at their second (AOR = 2.91, 95% CI [1.12–6.64]) and third trimesters (AOR = 4.32, 95% CI [1.37–6.81]), had chronic illness (AOR = 7.54, 95% CI [2.34–14.68]), and live in rural areas (AOR = 2.47, 95% CI [1.56–8.43]).Conclusion: The study revealed that the prescription pattern in the hospital is in line with the WHO reference. Age, gravidity, number of ANC visits, first visit to the facility, presence of chronic illness, educational status, and residency were significantly associated with prescription drug use in pregnant mothers. But still, some pregnant women received drugs that may have teratogenicity risk (FDA Category C).

Pregnancy-related adverse events associated with statins: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS)

ABSTRACT Background Statins, previously rated as pregnancy category X agents, were contraindicated during pregnancy due to the teratogenic effects observed in animal studies. However, it is still controversial whether statins have detrimental impact on pregnant women or not, and some studies even suggest a potential benefit of statin use against pregnancy complications. The aim of this study was to explore whether maternal exposure to statins is associated with increased rates of pregnancy-related adverse events (AEs), including abortion, abortion spontaneous, preterm birth, low birth weight, stillbirth/fetal death, and fetal complications. Research design and methods Data from 1 January 2004 to 30 June 2022 were extracted through the U.S. FDA Adverse Event Reporting System (FAERS) database, to conduct disproportionality analysis and Bayesian analysis by reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) algorithms. To identify the potential risks of pregnancy-related AEs, each statin was compared to all the other drugs, all the other statins, and the reference drugs (fenofibrate and evolocumab). Results A total of 477 cases involving pregnancy-related AEs associated with stains were submitted to the FAERS database by healthcare professionals. No obvious disproportionate association of abortion, abortion spontaneous, or stillbirth/fetal death was identified for all statins during gestation. In comparison with all the other drugs, lovastatin showed an increased risk of fetal complications (ROR = 2.45, 95% CI, 1.22–4.95; IC025 = 0.63), and pravastatin demonstrated increased risks of preterm birth (ROR = 4.89, 95% CI, 3.65–6.54; IC025 = 1.69) and low birth weight (ROR = 9.60, 95% CI, 5.56–16.56; IC025 = 1.88). Similar results were found when compared lovastatin or pravastatin with fenofibrate. Furthermore, statins were associated with higher proportion of fetal complications and preterm birth when comparing with evolocumab. Conclusions Statins did not increase the risk of pregnancy-related AEs, including abortion, abortion spontaneous, or stillbirth/fetal death. However, we did find significant disproportionality signals for preterm birth and low birth weight associated with pravastatin, and lovastatin was related to a higher proportion of fetal complications. The results in this study may provide evidence on the safety of statins during pregnancy, which need to be verified in further investigations.

Dermatologic Drug Safety in Pregnancy

In 2014, the US FDA removed the Pregnancy Category Drug lettering system and enacted the “Pregnancy and Lactation Label Ruling.” This ruling required drug products to contain contact information for drug-specific exposure pregnancy registries, narrative-style sections summarizing the known effect of pregnancy, lactation counseling data, and data describing risks for females and males of reproductive potential. This new ruling has added more dialogue and discussion to the patient-provider decision-making process and equires clinicians to provide more individualized counseling based on the current medical literature. This article summarizes the recent evidence for the safety of the most common dermatological therapies for pregnant and lactating women.

2D-QSAR modeling for risk assessment of pharmacotherapy applied during pregnancy.

The risk evaluation for pharmacological therapy during pregnancy is critical for maternal and fetal health. The initial risk assessment stage, the risk measurement, begins with pregnancy-labeling categories (A, B, C, D, and X) for pharmaceuticals defined by the US Food and Drug Administration (FDA). Recently, in silico methods have been preferred in toxicology studies to eliminate ethical issues before conducting clinical toxicology studies and animal experiments. Quantitative structure-activity relationship (QSAR) modeling is one of the in silico methodologies. The research focuses on creating a QSAR model that predicts the five FDA pregnancy categories of medications. Our dataset included 868 pharmaceuticals containing nearly every pharmacological group collected from the FDA. 2D-molecular descriptors were calculated using PaDEL software. Twenty-four QSAR models were developed, and the best four models were discussed. The results of the models were compared according to sensitivity, accuracy, F-score, specificity, ROC values, and Matthews correlation coefficient. Considering the statistical results, Random Forest is the best model for determining the pregnancy risk category of drugs. The accuracy of the model was 76.49% for internal and 93.58% for external validation. According to the kappa statistics, there is an average agreement of 0.583 for internal and a perfect agreement of 0.893 for external validation. Since the error rates of the model are very close to 0, the model is highly accurate. Consequently, our novel QSAR model gives guidance on the safe use of pharmaceuticals during pregnancy without requiring animal tests or clinical trials on pregnant women.

Analyzing trends in treatment of acne vulgaris in pregnancy: a retrospective study.

Analyzing trends in treatment of acne vulgaris in pregnancy: a retrospective study.

Exploring body dissatisfaction in pregnancy and the association with gestational weight gain, obesity, and weight stigma

ObjectiveBody dissatisfaction in pregnancy has been associated with negative psychological maternal outcomes, including increased risk of postpartum depression. This study aimed to explore weight-related factors that influence body dissatisfaction in pregnancy, including gestational weight gain (GWG), weight stigma, obesity, and weight loss attempts before pregnancy. DesignSecondary analysis of a larger cross-sectional study. SettingOnline survey administered via Qualtrics. Participants≥12 weeks pregnant, ≥18 years of age, having a singleton pregnancy and residing in Canada. Measurements and FindingsA battery of questionnaires were completed, including the Body Image in Pregnancy Scale (BIPS) sub-scale. The BIPS scores were compared based on experiences of weight stigma in pregnancy, perception towards their GWG, weight loss attempts before pregnancy, obesity, and GWG category classified as excessive or not referring to Institute of Medicine (2009) guidelines. Significant differences were entered into a linear regression model with BIPS scores as the dependent variable. Significance was accepted as p<0.05. A total of 182 participants completed the survey. There were no differences in BIPS scores based on GWG category (p = 0.160), or obesity (p = 0.230). Poorer BIPS scores were reported by those who felt they had gained ‘too much’ pregnancy weight than ‘appropriate’ (p<0.001), and among those who were trying to lose weight before pregnancy compared to those who were not (p = 0.002). Poorer BIPS scores were also reported by individuals who indicated they had experienced weight stigma during pregnancy compared to those who had not (p<0.001). Regression results showed that significant variables were perceptions towards GWG (p = 0.003) and experiencing weight stigma in pregnancy (p = 0.011). Key Conclusions and Implications for PracticePerceptions towards GWG and experiencing weight stigma can influence body dissatisfaction in pregnancy. Given the detrimental physical and psychological consequences of body dissatisfaction, effective strategies to reduce prenatal weight stigma are needed, such as training maternal healthcare providers to offer sensitive preconception and prenatal weight counselling.

Determination and risk assessment of pharmaceutical residues in the urban water cycle in Selangor Darul Ehsan, Malaysia.

The environmental fate of non-steroidal anti-inflammatory drugs (NSAIDs) in the urban water cycle is still uncertain and their status is mainly assessed based on specific water components and information on human risk assessments. This study (a) explores the environmental fate of NSAIDs (ibuprofen, IBU; naproxen, NAP; ketoprofen, KET; diazepam, DIA; and diclofenac, DIC) in the urban water cycle, including wastewater, river, and treated water via gas chromatography-mass spectrophotometry (GCMS), (b) assesses the efficiency of reducing the targeted NSAIDs in sewage treatment plant (STP) using analysis of variance (ANOVA), and (c) evaluates the ecological risk assessment of these drugs in the urban water cycle via teratogenic index (TI) and risk quotient (RQ). The primary receptor of contaminants comes from urban areas, as a high concentration of NSAIDs is detected (ranging from 5.87 × 103 to 7.18 × 104 ng/L). The percentage of NSAIDs removal in STP ranged from 25.6% to 92.3%. The NAP and KET were still detected at trace levels in treated water, indicating the persistent presence in the water cycle. The TI values for NAP and DIA (influent and effluent) were more than 1, showing a risk of a teratogenic effect. The IBU, KET, and DIC had values of less than 1, indicating the risk of lethal embryo effects. The NAP and DIA can be classified as Human Pregnancy Category C (2.1 > TI ≥ 0.76). This work proved that these drugs exist in the current urban water cycle, which could induce adverse effects on humans and the environment (RQ in high and low-risk categories). Therefore, they should be minimized, if not eliminated, from the primary sources of the pollutant (i.e., STPs). These pollutants should be considered a priority to be monitored, given focus to, and listed in the guideline due to their persistent presence in the urban water cycle.

Evaluation of the Drug Utilization Pattern among Pregnant Women in a Tertiary Care Teaching Hospital

A retrospective study was conducted in a tertiary care teaching hospital to evaluate the drug utilization pattern in pregnant women. A total of 876 pregnant women were enrolled in the study. Parameters such as demography, gravidity, comorbid illness, neonatal outcome, drugs prescribed and their utilization details were collected. The mean age of the study population was found to be 29.4±4.4 y (mean±standard deviation). Majority of them underwent caesarean section (68.2 %) compared to normal vaginal delivery (31.8 %). Most of the neonates were healthy (94.3 %) whereas 0.8 % of the neonates expired during the postnatal period. Diabetes mellitus (33.6 %) was the most common comorbidity, followed by hypertension (28.3 %) and thyroid disorders (18.3 %). Folic acid (15.7 %) and calcium (15.2 %) were the most prescribed drugs, followed by ferrous fumarate (7.1 %), vitamin B12 (5.3 %) and vitamin B6 (3.4 %). In terms of defined daily dose/100 bed d, levothyroxine (369.3) was the most frequently utilized drug, followed by digoxin (53.6), dydrogesterone (27.4) and salbutamol (20.5). Estradiol was only the food and drug administration pregnancy category X drug prescribed, as estradiol supplement as this was required to improve pregnancy rates after in vitro fertilization.

Hubungan Antara Paritas Dengan Tingkat Kecemasan Ibu Hamil Di Griya Arin, Yogyakarta

Approximately 10% of pregnant women experience depression and this condition is higher in developing countries, reaching 15.6% during pregnancy and 19.8% after delivery. Mothers who experience anxiety during pregnancy will affect the intrauterine environment and fetal development. The majority of Primigravida mothers do not have experience and how to handle pregnancy until the delivery process goes smoothly, causing anxiety when compared to multigravidas. The purpose of this study was to determine the relationship between parity and anxiety levels. To determine the relationship between parity and the anxiety level of pregnant women with TM II and III. The type of research used is an analytic survey with a cross sectional approach. The population in this study were all pregnant women with TM II and III at Griya Arin using a purposive random sampling technique with a total of 30 respondents. The data analysis used was the Spearman rho correlation nonparametric statistical test.The parity of most pregnant women in the multigravida pregnancy category was 60% (18 people), while the anxiety level of most pregnant women was in the moderate category, namely 73.3% (22 people). There is a parity relationship with the level of anxiety in pregnant women at Griya Arin Yogyakarta with a p-value of 0.039 and an odds ratio of 1.000 . There is a relationship between parity and the level of anxiety in pregnant women at Griya Arin Yogyakarta.

Effect of tramadol hydrochloride on neural tube development in 48-hr chick embryos: Argyrophilic nucleolar organizing region and genetic analysis study.

Tramadol hydrochloride or tramadol is an opioid analgesic that acts on the central nervous system. The pregnancy category of tramadol is determined as "C" according to the Food and Drug Administration. There are no adequate and well-controlled studies in pregnant women. In this study, we aimed to reveal the effects of tramadol on neural tube (midline) closure by analyzing morphologically, histologically and genetically in chick embryos. Ninety White Leghorn species, fertile and 0-day-old specific pathogen-free eggs (60 ± 5g) were used in the study. Eggs were divided into a total of six groups (control, sham, and drug groups). Four different doses of tramadol (1, 2.5, 5, and 7.5mg/egg) were administered subblastodermically at the 28th hour of the incubation. All eggs were opened at the 48th hour of incubation and evaluated. Embryos in the control group according to Hamburger-Hamilton classification were compatible with stages 13 and 14. In the groups treated with tramadol, it was determined that the embryos had neural tube closure defects (such as neck, tail regions) and some embryos showed developmental retardation due to the increase in the drug dose. In the statistical analysis performed, a significant difference was found between the control group and the group receiving the highest dose of tramadol in terms of crown-rump length and number of somites (p< .05). The brain and reproductive expression gene expression was upregulated in embryos at each of tramadol doses compared to control group. It was determined that tramadol causes neural tube closure defects in embryos depending on the dose.

Abstract 11600: Characteristics and Outcomes of Statin Use During Pregnancy: A US Real-World Experience

Introduction: Statins traditionally have been contraindicated during pregnancy because of a theoretical risk of teratogenicity. However, emerging evidence to suggest relative safety and potential harm in contraindicating statins in high cardiovascular (CV)-risk pregnancies have led the FDA in 2021 to remove the “Pregnancy Category X” label. This has placed a heavy burden on physician-patient (pt) shared decision making in that statins “should be discontinued in most pregnant patients or consider the ongoing therapeutic needs of the individual pt, particularly those at very high risk for CV events during pregnancy”. Methods: The objective of this study was to describe the current real-world characteristics of pts prescribed a statin during pregnancy and pregnancy outcomes in a large US healthcare system. Pregnant pts taking a statin were identified by a search of the electronic medical records (eMR) of Intermountain Healthcare, a system of 24 hospitals and 215 clinics in Utah, Idaho, and Nevada, between 1997 and 2021, and pregnancy outcomes determined electronically. Statin pts were matched 1:10 by age (+/- 1 y) with non-statin pts. Characteristics and outcomes were determined, and adjusted odds ratios (aOR) were calculated. Results: A total of 63 statin-user pregnancies were matched to 630 controls. Stain pts had more co-morbidities and higher baseline lipids (Table 1). Adverse pregnancy outcomes were more frequent in statin users (Table 2A). However, statin use did not contribute significantly to multivariable risk prediction of miscarriage or congenital anomalies although possibly it did to eclampsia/preeclampsia (Table 2B). Conclusions: In a current real-world US experience, pts prescribed statins during pregnancy had more comorbidities and more adverse outcomes, including fetal anomalies. However, after adjustment, statin use did not contribute to multivariable risk prediction of miscarriage or congenital anomalies.

Karakteristik Gestasional Dan Klinis Ibu Hamil Dengan Resiko Di Wilayah Kerja Puskesmas Banjar 1

High-risk pregnancy is one of the conditions that can indirectly or directly harm the condition of the mother and baby, which can be prevented if the risk in pregnancy is detected early. In reality, pregnant women who are at high risk or low risk rarely make regular antenatal care visits, so the information they have about risky pregnancies and the importance of antenatal visits is still lacking. The schedule of visit examinations for high-risk pregnant women is carried out more regularly and regularly in accordance with the nature of the risk factors that exist in pregnant women and supporting examinations that need to be carried out. This study aims to look at gestational and clinical characteristics in pregnant women at risk. Research is a descriptive quantitative research with a cohort study and a retrospective approach. This descriptive research was used to examine the incidence of pregnancy at risk at the Banjar I Health Center by utilizing the maternal cohort register in the last 1 (one) year. The results showed that the low-risk pregnancy category was 80.7% (343/425) while the high-risk category was 19.29% (82/425). Gestational characteristics in pregnant women with low risk, healthy reproductive age of 88.34% (303), distance of less than 2 years 55.10 % (189) with an average age of 38.9 weeks while the high risk group with an unhealthy reproductive age of 68.29 % (56), distance of more than 2 years 80.49% (66) with an average age of 39.02 weeks. Clinical characteristics in low-risk pregnant women are average weight 58.8 kg, height 159.5 cm, blood pressure 112.56, risk score for pregnant women 2.3 and LILA 27.3 cm. In high-risk pregnant women with an average weight of 60 kg, height 172.2 cm, blood pressure 114.4, risk score of pregnant women 7.3, and LILA 27.9 cm. The results of this study can be used as input for midwives in order to provide the right IEC and carry out early detection in every pregnancy.