Inpatient Women Research Articles

Psychotherapy on an Acute Psychiatric Ward: Preliminary Findings From a Controlled Study.

This study investigated the efficacy of psychotherapy during hospitalization on an acute psychiatric ward. A controlled trial was conducted to assess the effects of Metacognitive Reflection and Insight Therapy (MERIT) upon metacognition and psychiatric symptoms. Data from 40 inpatient women were analysed. Findings included significant interaction effects between group (intervention or control group) and time (preintervention and postintervention) in regard to the metacognitive abilities and general psychiatric symptoms. Participating in MERIT seems to improve one's ability to use reflective knowledge to cope with psychological challenges and to improve symptomatology level.

Machine learning-enabled maternal risk assessment for women with pre-eclampsia (the PIERS-ML model): a modelling study

Affecting 2-4% of pregnancies, pre-eclampsia is a leading cause of maternal death and morbidity worldwide. Using routinely available data, we aimed to develop and validate a novel machine learning-based and clinical setting-responsive time-of-disease model to rule out and rule in adverse maternal outcomes in women presenting with pre-eclampsia. We used health system, demographic, and clinical data from the day of first assessment with pre-eclampsia to predict a Delphi-derived composite outcome of maternal mortality or severe morbidity within 2 days. Machine learning methods, multiple imputation, and ten-fold cross-validation were used to fit models on a development dataset (75% of combined published data of 8843 patients from 11 low-income, middle-income, and high-income countries). Validation was undertaken on the unseen 25%, and an additional external validation was performed in 2901 inpatient women admitted with pre-eclampsia to two hospitals in south-east England. Predictive risk accuracy was determined by area-under-the-receiver-operator characteristic (AUROC), and risk categories were data-driven and defined by negative (-LR) and positive (+LR) likelihood ratios. Of 8843 participants, 590 (6·7%) developed the composite adverse maternal outcome within 2 days, 813 (9·2%) within 7 days, and 1083 (12·2%) at any time. An 18-variable random forest-based prediction model, PIERS-ML, was accurate (AUROC 0·80 [95% CI 0·76-0·84] vs the currently used logistic regression model, fullPIERS: AUROC 0·68 [0·63-0·74]) and categorised women into very low risk (-LR <0·1; eight [0·7%] of 1103 women), low risk (-LR 0·1 to 0·2; 321 [29·1%] women), moderate risk (-LR >0·2 and +LR <5·0; 676 [61·3%] women), high risk (+LR 5·0 to 10·0, 87 [7·9%] women), and very high risk (+LR >10·0; 11 [1·0%] women). Adverse maternal event rates were 0% for very low risk, 2% for low risk, 5% for moderate risk, 26% for high risk, and 91% for very high risk within 48 h. The 2901 women in the external validation dataset were accurately classified as being at very low risk (0% with outcomes), low risk (1%), moderate risk (4%), high risk (33%), or very high risk (67%). The PIERS-ML model improves identification of women with pre-eclampsia who are at lowest and greatest risk of severe adverse maternal outcomes within 2 days of assessment, and can support provision of accurate guidance to women, their families, and their maternity care providers. University of Strathclyde Diversity in Data Linkage Centre for Doctoral Training, the Fetal Medicine Foundation, The Canadian Institutes of Health Research, and the Bill & Melinda Gates Foundation.

Women’s Satisfaction with Hospital Based Intrapartum Care in a Medical College of Western Nepal

INTRODUCTION Birth satisfaction is a multi-dimensional concept comprising structure, process and outcome of care that influence postnatal adjustment. Mother’s satisfaction during the birthing process is an important indicator in evaluating quality of maternity services. The aim of the study is to find out the women’s satisfaction with hospital based intrapartum care in a medical college of western Nepal. MATERIAL AND METHODS Cross-sectional analytical study was conducted to find women’s satisfaction with hospital based intrapartum care in a medical college of western Nepal among 332 postpartum inpatient women delivered in Lumbini Medical College and Teaching Hospital, Pravas, Palpa, who were selected by using purposive sampling technique. A pretested interview schedule was used for data collection. Descriptive statistics and inferential statistics were used for data analysis. RESULTS The study findings revealed that about half of the respondents (50.9%) were satisfied with hospital based intrapartum care. The level of satisfaction was significantly associated with gravida (p=0.008), type of labor onset (p=0.007) and episiotomy status (p&lt;0.001). CONCLUSION The study findings conclude that women attending teaching hospital for delivery tend to be somewhat satisfied with hospital based intra-partum care. Adequate counseling, reassurance and supportive care of women during intrapartum period might increase their satisfaction with intrapartum care.

The Relationship Between Women's Health Literacy and Breast Cancer Concern Levels

The research was done descriptively and cross-sectionally to define the relationship between women's health literacy and their anxiety levels regarding breast cancer. 315 female patients participated in the study who are over the age of 20 and inpatient women of a training and research hospital. The interval of study was three months (May and July 2022). Researchers obtained the research data with face-to-face interview technique and they used the "Personal Information Form", "Breast Cancer Concern Scale (BCCS)", and "Health Literacy Scale (HLS)". The mean HLS and BCSS scores of women were 103.8±19 and 9.2±5.6 respectively. It has been found that women's employment status, menopause, education level and knowledge of breast self-examination (BSE) and having BSE have an impact on their level of health literacy. With correlation analysis, it was defined that there was a statistically insignificant and low level, negative relationship between the women’s total mean scores of HLS and the BCCS (r=-0.06, p&gt;0.05). As a result, it was determined that women had above moderate level of health literacy and low level of anxiety about breast cancer, and there was no relationship between health literacy level and breast cancer anxiety. The results showed that women's education level, working outside the home, menopause status, and whether they know and regularly practice BSE affect their health literacy.

Placental Endocan Expression in Woman With Preeclampsia and its Relation With Maternal and Fetal Outcomes: A Cross-section Study

Objectives: This study aimed to determine placental endocan expression in women with preeclampsia (PE) and its relation to fetal and maternal outcomes. Materials and Methods: This cross-sectional study was carried out at the Obstetrics Department/Al-Yarmouk Teaching Hospital from January 2020 to October 2020. The study included 90 pregnant inpatient women with PE. The participants were divided into 3 groups including 30 patients with severe PE, 30 non-severe PE, and 30 normotensives. After delivery, placental endocan expression was determined immunohistochemically. Results: The study showed that endocan was expressed in 44 patients’ placenta, all of them were hypertensive vs. 46 negatives for endocan (P=0.001), this expression correlated with adverse maternal outcomes including HELLP (haemolysis, elevated liver enzymes, and low platelets count) syndrome (9.1%), Placental abruption (13.6%) and increase rate of CS (63.6%), as well as adverse fetal outcomes (P=0.001). included stillbirth (13.6%), birth weight &lt;2500 g (68.2%), Apgar score in 1 min &lt;7 (63.6%) and in 5 minutes &lt;7 (31.8), admission to neonatal intensive care unit (NICU) (31.8%), and (68.2%) delivered preterm. Conclusions: This study showed a higher expression of endocan in the placenta of women with PE, and it had a positive correlation with adverse maternal and fetal outcomes.

Evolving Orientation for Graduate Nurses Who Were Educated During COVID-19

Graduate nurses displayed a difficult time integrating into bedside nursing due to the reduction or elimination of in-person clinical experience related to COVID-19 precautions. Because they had limited clinical experiences, new graduate nurses needed more educational focus, as exhibited by poor progression throughout orientation. Routine orientation procedures used previously were not meeting the needs of the graduate nurses, as exhibited by increases in orientation time and turnover rate. Nursing education and leadership on inpatient women’s health, obstetric, or neonatal units. Implementation of a new orientation toolkit, with weekly expectations for the learner. This system is accompanied by rounding on the orientees biweekly to determine their educational needs and online learning formats to supplement clinical experience. The orientation toolkit includes a color-coded system, like a stoplight, to indicate expectations for patient assignments and skills. The color-coding system indicates expectations for the patient assignments and skill checklists. This system provides transparency between the preceptor and orientee to determine if expectations have been met. The orientation toolkit and check-ins with the leadership aim to improve communication with graduate nurses. The clinical experiences are paired with online learning modules to ensure a well-rounded orientation. A survey was conducted to determine the level of nurse satisfaction with nursing orientation. Survey respondents included nurses who completed orientation before the change and now are precepting with the new education plan, nurses who completed orientation before the new education plan, and nurses who were on orientation with the new education plan. Of 29 respondents, 72.7% reported a positive change in orientation and satisfaction with orientation. In a comparison of new-nurse turnover data from January 2021 to December 2021 and January 2022 to June 2022, there was a decrease in turnover, from 52.4% to 20.9%. To increase the knowledge base of nursing education to increase nursing satisfaction and decrease turnover.

Creative arts intervention in support of women experiencing a high-risk pregnancy: A qualitative descriptive thematic analysis

BackgroundMental illness can have negative effects on both the pregnant woman and her unborn child. Studies that use the creative arts as interventions have proven to be beneficial to women's antenatal mental health and wellbeing, however, these studies are limited and emergent. Music, drawing and narrative (MDN) is an established music therapy intervention, stemming from guided imagery and music (GIM), that has the potential to support positive mental health and wellbeing. Yet, to date, there have been limited studies on the use of this form of therapy with inpatient antenatal women. AimTo describe antenatal inpatient women’s experiences of participating in a MDN session. MethodsQualitative data were collected from a sample of 12 inpatient pregnant women who participated in MDN group sessions of drawing to music. Post intervention interviews explored the mental and emotional health of participants. A thematic analysis of the transcribed interview data was performed. FindingsThrough reflection women were supported to acknowledge both the positives and difficulties of pregnancy as well as establish meaningful connections through shared experience. These thematic findings highlighted that MDN enabled this group of pregnant women to better communicate their feelings, validate emotions, engage in positive distractions, develop greater connections, improve optimism, experience calmness, and learn from others. ConclusionThis project demonstrates that MDN may offer a viable method for supporting women experiencing high risk pregnancies.

Effect of menopausal hormone therapy on COVID-19 severe outcomes in women – A population-based study of the US National COVID Cohort Collaborative (N3C) data

Whether menopausal hormone therapy (MHT) lessens the severity of COVID-19 among women is unclear. Leveraging a U.S. national COVID-19 cohort and a cross-sectional analysis, we found MHT use was marginally associated with a lower risk of mortality (odds ratio [OR] 0.73, 95 % CI 0.53–1.01) and significantly associated with a lower risk of prolonged hospital stay (0.7, 0.49–0.99) among inpatient women. When stratifying by MHT type, estrogen-only and estrogen-plus-progestin therapies had a more prominent protective effect than progestin-only therapy, although this difference did not achieve statistical significance. Women with COVID-19 can continue to use MHT. Clinical trials are needed to evaluate MHT's therapeutic effect on COVID-19, especially in terms of severity.

O14 - Creative Arts Intervention in Support of Women Experiencing a High-Risk Pregnancy

There are clearly elucidated associations between poor perinatal mental health and adverse pregnancy and birth outcomes. Non-pharmacological treatment options are under researched, emergent and few. Music, Drawing and Narrative (MDN) is seen as a beneficial therapeutic modality in other areas of health and could benefit inpatient women experiencing a high-risk pregnancy. To assess the acceptability of MDN as an art and music based therapeutic intervention for women who are admitted to hospital whilst experiencing a high-risk pregnancy. Singleton pregnant women (n=12) at 24-week gestation or more admitted to Flinders medical centre- antenatal ward, for longer than 5 consecutive days, were eligible for inclusion. Data collection spanned the period of 18 months from July 2020- 2021 and was undertaken by the project leader. Women participated in a standalone group therapeutic MDN session and were interviewed to better understand the effects of the intervention. Analysis comprised of a thematic analysis. Four emergent themes were identified. First, the impact of the MDN components on participant experience. Second, therapeutic process reflecting the journey that facilitated acknowledgment of the difficulties and positives of pregnancy. Third, Calm and relaxed as a direct result of involvement in intervention. Lastly, connection through shared experience. Consequently, MDN enabled this group of pregnant women to better express themselves, sort through emotions, find a positive distraction from real stressors, feel more connected with their baby, develop optimism, experience calmness, and connect and learn from others. MDN may offer a viable and cost-effective method for supporting women experiencing high risk pregnancies. These results support the growing body of literature that indicates creative arts interventions are beneficial to women's psychosocial health.

Psychosocial needs of inpatient women with gestational diabetes mellitus: a qualitative study

ABSTRACT Background Gestational diabetes mellitus (GDM) is one of the most common medical complications associated with pregnancy. Its treatment requires multidisciplinary cooperation, and identifying the psychosocial needs of patients is important in the management of their condition. Objective This study investigates the psychosocial needs of inpatient mothers with GDM from the joint perspectives of future mothers and healthcare providers. Methods This qualitative study used a content analysis approach. Semi-structured individual interviews focusing on the psychosocial needs of women with GDM were conducted with twelve women suffering from GDM and eight medical staff. Sampling continued until data saturation. Results According to the findings of this study, the psychosocial needs of these mothers were classified into the following categories: Support for worries related to the consequences of the disease, Interpersonal support, Infrastructural support, educational support. Conclusion The psychosocial needs of inpatient mothers with GDM were identified in this study. Attention to these needs can help enhance the mother’s satisfaction and treatment adherence, and reduce worries and anxiety during hospitalisation. Abbreviations GDM: Gestational Diabetes Mellitus; hPGH: human placental growth hormone; COREQ: Consolidated criteria for reporting qualitative research; WHO: World Health Organization; HCP: healthcare provider.

Diagnoses and procedures of inpatients with female genital mutilation/cutting in Swiss University Hospitals: a cross-sectional study

BackgroundFemale genital mutilation/cutting (FGM/C) can result in short and long-term complications, which can impact physical, psychological and sexual health. Our objective was to obtain descriptive data about the most frequent health conditions and procedures associated with FGM/C in Swiss university hospitals inpatient women and girls with a condition/diagnosis of FGM/C. Our research focused on the gynaecology and obstetrics departments.MethodsWe conducted an exploratory descriptive study to identify the health outcomes of women and girls with a coded FGM/C diagnose who had been admitted to Swiss university hospitals between 2016 and 2018. Four of the five Swiss university hospitals provided anonymized data on primary and secondary diagnoses coded with the International Classification of Diseases (ICD) and interventions coded in their medical files.ResultsBetween 2016 and 2018, 207 inpatients had a condition/diagnosis of FGM/C. The majority (96%) were admitted either to gynaecology or obstetrics divisions with few genito-urinary and psychosexual conditions coded.ConclusionsFGM/C coding capacities in Swiss university hospitals are low, and some complications of FGM/C are probably not diagnosed. Pregnancy and delivery represent key moments to identify and offer medical care to women and girls who live with FGM/C.Trial registration: This cross-sectional study (protocol number 2018-01851) was conducted in 2019, and approved by the Swiss ethics committee.

Health literacy and health promoting behaviors among inpatient women during COVID-19 pandemic

BackgroundOne of the leading health indicators during the COVID-19 crisis is health literacy and health-promoting behaviors. The present study aimed to investigate health literacy and health-promoting behaviors among women hospitalized during the COVID-19 pandemic in the southern part of Iran in 2020.MethodsThis descriptive-analytical study encompassed 465 women hospitalized and treated in none teaching hospitals affiliated with the Shiraz University of Medical Sciences. Data collection tools were the Health Literacy for Iranian Adults (HELIA) and Health Promoting Lifestyle Profile II (HPLP-II). The collected data were analyzed using descriptive and inferential statistical methods.ResultsThe mean scores of the participants’ "health literacy" and "health-promoting behaviors" were 64.41 ± 11.31 and 112.23 ± 16.09, respectively, indicating the poor level of health literacy and the average level of health-promoting behaviors. Moreover, there was a significant direct correlation between health literacy and health-promoting behaviors (P < 0.001, r = 0.471). Furthermore, all health literacy dimensions of comprehension (P < 0.001), accessibility (P < 0.001), reading skills (P < 0.001), evaluation (P = 0.002), and decision making and behavior (P = 0.003) were detected as the predictors of health-promoting behaviors. Further, statistically significant relationships were noticed between the mean score of health literacy with age (r = − 0.327, P = 0.007), level of education (F = 3.119, P = 0.002), and place of residence (t = 2.416, P = 0.004) and between health-promoting behaviors with level of education (F = 3.341, P = 0.001) and marital status (F = 2.868, P = 0.02).ConclusionAccording to the findings, health policymakers should adopt national measures for educational planning to promote health literacy and support health-promoting behaviors to encourage women to adopt a healthy lifestyle.

Effect of positioning on blood pressure measurement in pregnancy.

Blood pressure is the key vital sign to detecting hypertensive disorders in pregnancy. The importance of taking blood pressure properly was recently underscored by the publication of updated ACC/AHA guidelines for measuring blood pressure in patients. However, the recommended position of seating with arms and back supported is not always feasible to achieve clinically, especially for inpatient women who are pregnant. Therefore, it is clinically important to understand the effects of alternative patient positioning on blood pressure measurements. We conducted a review of studies which considered patient position on the effect of blood pressure in pregnancy. This review demonstrates that clinically significant differences may occur based on patient positioning. Despite the small number of primary studies that include pregnant women, notable reductions in blood pressure measurements have been observed in the left lateral recumbent position, a common position during labor or during monitoring, in comparison to measurements taken in the supported seated position. Ultimately, these differences could affect the clinical management of patients and care should be taken to document and consider the position in which the reading was taken.

Multi-Layered Catastrophic Health Spending of Inpatient Women by Broad Group of Diseases in India

Healthcare for Indian women needs prioritizing, as they continue to face social and economic discrimination over their healthcare, often with high out-of-pocket payments. The study examines the amount inpatient women have to pay for treatment of major diseases, re-classified into four groups as infectious, reproductive, non-communicable diseases (NCDs), and disabilities &amp; injuries, across the country to comprehend the extent of catastrophic health spending (CHS) they experienced. The study is based on India’s 75th round of the National Sample Survey (NSS), i.e., Household Social Consumption: Health (2017-2018), consisting of 26,938 inpatient women aged 12 and above from India's urban and rural areas. We examine the prevalence of the four categories of diseases by individual, household, community, and healthcare characteristics. Expenditure estimates were derived from cross-tabulation, followed by binary logistic regression to assess the association between covariates and inpatient expenditures for the diseases. Indian women are more likely to be hospitalized for infectious diseases (43%), but the burden of CHS (overall) is highest for disabilities and injuries (INR 24,414), followed by NCDs (INR 23,053). Duration of hospitalization and possession of health insurance by women indicate maximum variation with medical spending. Almost 97% of women have incurred out-of-pocket expenditure on hospitalization, from which we identify three layers of CHS. A substantial proportion of women (23 to 50%) experienced CHS, i.e., up to 0-10%, 11-30%, and &gt;30%, which varies distinctively by place of residence and across the six regions. Covariates like age, economic status, and healthcare are highly significant and associated with disease-wise CHS thresholds. Women in India face divergent financial hardships for healthcare. Given the heterogeneity of morbidities and socio-economic characteristics, the need for women-sensitive public health services and interventions are evident.

Emotional Infant Face Processing in Women With Major Depression and Expecting Parents With Depressive Symptoms.

Processing of emotional facial expressions is of great importance in interpersonal relationships. Aberrant engagement with facial expressions, particularly an engagement with sad faces, loss of engagement with happy faces, and enhanced memory of sadness has been found in depression. Since most studies used adult faces, we here examined if such biases also occur in processing of infant faces in those with depression or depressive symptoms. In study 1, we recruited 25 inpatient women with major depression and 25 matched controls. In study 2, we extracted a sample of expecting parents from the NorBaby study, where 29 reported elevated levels of depressive symptoms, and 29 were matched controls. In both studies, we assessed attentional bias with a dot-probe task using happy, sad and neutral infant faces, and facial memory bias with a recognition task using happy, sad, angry, afraid, surprised, disgusted and neutral infant and adult faces. Participants also completed the Ruminative Responses Scale and Becks Depression Inventory-II. In study 1, we found no group difference in either attention to or memory accuracy for emotional infant faces. Neither attention nor recognition was associated with rumination. In study 2, we found that the group with depressive symptoms disengaged more slowly than healthy controls from sad infant faces, and this was related to rumination. The results place emphasis on the importance of emotional self-relevant material when examining cognitive processing in depression. Together, these studies demonstrate that a mood-congruent attentional bias to infant faces is present in expecting parents with depressive symptoms, but not in inpatients with Major Depression Disorder who do not have younger children.

Female genital mutilation/cutting (FGM/C) coding capacities in Swiss university hospitals using the International Classification of Diseases (ICD)

BackgroundThe real prevalence and incidence of women living with or at risk of female genital mutilation/cutting (FGM/C) is unknown in Switzerland and many parts of Europe, as there are no representative surveys similar to DHS or MICS for European countries. Indirect estimates are commonly used to estimate the number of women with FGM/C in high-income countries, but may not reflect the actual FGM/C prevalence among migrants. Direct measures may provide more accurate estimates that could guide policy- and clinical decision-making. Swiss hospital data may provide a sample of patients that can be used to describe the prevalence of FGM/C in Swiss hospitals. Our study assesses the number of inpatient women and girls in Swiss university hospitals from countries with high FGM/C prevalence, and of inpatients with a coded diagnosis of FGM/C.MethodsWe conducted an exploratory descriptive study in Switzerland to assess the number of women and girls admitted to Swiss university hospitals between 2016 and 2018 from 30 FGM/C practicing countries, as well as inpatients with a coded diagnosis of FGM/C using anonymized data. We calculated indirect estimates for inpatient women and girls living with or at risk of FGM/C and compared them with the number of inpatients with a coded diagnosis of FGM/C.Results8720 women and girls from FGM/C practicing countries were admitted. 207 patients had a coded diagnosis of FGM/C, including 7 with a nationality outside the 30 targeted countries, corresponding to an overall prevalence of 2.3% (95%CI, 2.0–2.6). The number of FGM/C cases by hospital was significantly different across years (P < 0.001), with a higher proportion of cases collected in Geneva, Switzerland.ConclusionsThe comparison between indirect estimates of inpatients with or at risk of FGM/C and the low number of FGM/C cases coded, suggests low recording and coding capacities of FGM/C.Tweetable abstractThe capacity of coding primary and secondary diagnosis of FGM/C in Swiss university hospitals seems low.Protocol number: 2018–01851: SwissEthics Committee, Canton of Geneva, Switzerland.

The Role of Alcohol Dependence and Depressive Disorder in Childhood Adversities and Reproductive History Traits in Inpatient Women: a Mediation Analyses

The Role of Alcohol Dependence and Depressive Disorder in Childhood Adversities and Reproductive History Traits in Inpatient Women: a Mediation Analyses

Coronavirus disease 2019 in pregnant and non-pregnant women: a retrospective study.

Coronavirus disease 2019 in pregnant and non-pregnant women: a retrospective study.

Further evidence that endometriosis is related to tubal and ovarian cancers: A study of 271,444 inpatient women

ObjectiveTo evaluate associations between endometriosis and tubal and ovarian cancers in a large population-based study. MethodsThe Health Care Cost and Utilization Project – National Inpatient Sample databases from 2005 to 2014 were used in this study. Data on patients with a diagnosis of tubal or ovarian cancer and endometriosis (overall and subtypes including adenomyosis and pelvic endometriosis) using International Classification of Diseases, Ninth Edition, Clinical Modification codes were extracted. Logistic regression analysis was performed to evaluate associations between tubal and ovarian cancers and endometriosis. Adjustment was made for age, race, median income level, payment plan, hospital location and obesity. ResultsOf 38,800,139 women aged >18 years who were hospitalized between 2005 and 2014, 271,444 women with adenomyosis and/or pelvic endometriosis, 4289 women with tubal cancer and 133,253 women with ovarian cancer were identified. The rate of tubal cancer was three-fold higher in women with endometriosis compared with women without endometriosis (0.03 % vs 0.01 %). The odds ratio (OR) adjusted for age, race, obesity, income and insurance type was 4.02 [95 % confidence interval (CI) 3.17–5.11; p < 0.01]. The rate of tubal cancer was higher in women with adenomyosis (0.04 % vs 0.01 %; adjusted OR 4.88, 95 % CI 3.66–6.50; p < 0.01) and women with pelvic endometriosis (0.02 % vs 0.01 %; adjusted OR 2.80, 95 % CI 1.84–4.27; p < 0.01) compared with women without these conditions. Similar associations were found between ovarian cancer and pelvic endometriosis and ovarian cancer and adenomyosis. ConclusionBoth pelvic endometriosis and adenomyosis are strongly associated with tubal and ovarian cancers.

Fetal safety of nicotine replacement therapy in pregnancy: systematic review and meta-analysis.

Smoking in pregnancy causes substantial avoidable harm to mothers and offspring; nicotine replacement therapy (NRT) may prevent this, and is used to help women to quit. A recently updated Cochrane Review of randomized controlled trials (RCTs) investigating impacts of NRT in pregnancy focuses primarily on efficacy data, but also reports adverse impacts from NRT. Here we identify and summarize NRT impacts on adverse pregnancy outcomes reported in non-randomized controlled trials (non-RCTs). Systematic reviews and meta-analyses of RCTs and non-RCT studies of NRT in pregnancy, with design-specific risk of bias assessment and grading of recommendations, assessment, development and evaluations (GRADE) criteria applied to selected outcomes. Relevant Cochrane Review findings are reported alongside those from this new review. Seven RCTs were included; n=2340. Nine meta-analyses were performed; non-statistically significant estimates indicated potentially reduced risk from NRT compared with smoking for mean birth weight, low birth weight, preterm birth, intensive care admissions, neonatal death, congenital anomalies and caesarean section and potentially increased risks for miscarriage and stillbirth. GRADE assessment for mean birth weight and miscarriage outcomes indicated 'low' confidence in findings. Twenty-three non-RCTs were included; n=931 163. Eleven large studies from five routine health-care cohorts reported clinical outcomes; 12 small studies investigated mainly physiological outcomes within in-patient women given NRT. Findings from meta-analyses for congenital anomalies, stillbirth and preterm birth were underpowered and not in a consistent direction; GRADE assessment of confidence in findings was 'very low'. Routine health-care studies were of higher quality, but implications of reported findings were unclear as there was inadequate measurement and reporting of women's smoking. Available evidence from randomized controlled trials and non-randomized comparative studies does not currently provide clear evidence as to whether maternal use of nicotine replacement therapy during pregnancy is harmful to the fetus.