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1.
BJA Educ ; 24(9): 305-308, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39234154
2.
BJA Educ ; 24(9): 335-342, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39234158
3.
Article in English | MEDLINE | ID: mdl-39242356

ABSTRACT

BACKGROUND: Women in leadership in obstetrics and gynaecology in Australia and Aotearoa New Zealand have historically been underrepresented, despite forming a significant portion of the workforce. This study extends prior research from 2017, examining shifts in gender representation, attitudes, and perceived leadership barriers within the specialty. AIMS: The study aims to evaluate changes in gender diversity among leadership positions in the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and accredited training hospitals since 2017. Additionally, it seeks to understand current attitudes toward leadership and identify perceived barriers among RANZCOG consultants and trainees. MATERIALS AND METHODS: A cross-sectional approach was employed, utilising publicly available information, a survey distributed to RANZCOG members, and data from accredited training hospitals. Gender representation in leadership positions was analysed, and survey responses were collected from consultants and trainees to evaluate attitudes and perceived barriers. RESULTS: The study reveals an increase in women's representation in RANZCOG leadership, particularly on the council and in clinical leadership positions. While the proportion of women trainees remained stable, there was a noteworthy increase in women specialists. Survey responses revealed shared perceptions on leadership qualities but diverged on barriers, with more women expressing concerns about skillsets, caring responsibilities, and mentorship support. CONCLUSIONS: The findings underscore substantial progress in achieving gender equity in obstetrics and gynaecology leadership roles, attributed to RANZCOG initiatives, societal changes, and improved policies. Ongoing efforts, including structured mentorship and flexible arrangements, are recommended to sustain and further enhance gender representation and address specific barriers identified by women in the specialty.

4.
Cureus ; 16(8): e67211, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39295684

ABSTRACT

There is conflicting information in the medical literature regarding hemolysis, elevated liver enzymes, low platelet count syndrome (HELLP) and preeclampsia and whether they are subsets of a single disease or distinct complications of pregnancy. In numerous places, HELLP is described as a severe form or later stage of preeclampsia. However, a detailed medical literature search utilizing NCBI, PubMed, and Elicit: The AI Research Assistant clearly demonstrates that HELLP and preeclampsia are distinct diseases. While they share similarities, each one has unique diagnostic criteria, pathophysiology, and treatment. We believe that these entities should be taught as separate entities to medical students and residents because this will result in better patient care. Medical educational theories, including constructivism, demonstrate that initial learning experiences heavily influence future learning. The joining of HELLP and preeclampsia in medical school teaching materials is detrimental to students' and trainees' long-term understanding of these two serious complications of pregnancy.

5.
Article in English | MEDLINE | ID: mdl-39304317

ABSTRACT

BACKGROUND: Obstetric ultrasound is an important tool, aiding in screening, diagnosis, and surveillance throughout pregnancy. AIMS: To explore obstetric doctors', midwives', and sonographers' experiences and views of obstetric ultrasound in Victoria, Australia. To investigate the increasing role of obstetric ultrasound for clinical management, and the adequacy of resources and training for appropriate use of ultrasound in clinical management. MATERIALS AND METHODS: This cross-sectional study forms part of a multi-national CROss-Country Ultrasound Study (CROCUS) exploring the views of consumers and health professionals from high-, middle- and low-income countries. Qualitative studies conducted in several countries informed the construction of a quantitative survey. These quantitative surveys were distributed to 16 hospitals across regional and metropolitan Victoria, Australia. Descriptive statistics were analysed from the responses. RESULTS: There were 354 questionnaires returned from 106 doctors, 222 midwives, and 26 sonographers. Overall, 72% of respondents held concerns about the potential loss of focus on clinical skills with increasing ultrasound use. Midwives were more concerned about the contribution of ultrasound to medicalisation of pregnancy than were doctors (P < 0.001). Many respondents noted that geographical factors (71%), rather than income levels (53%) influenced access to obstetric ultrasound. Over 90% of doctors and midwives believed additional training for their respective professions in ultrasound would enhance its reach and effectiveness. CONCLUSIONS: Our survey findings confirm that clinicians place high levels of trust in the diagnostic findings of obstetric ultrasound antenatal care in Australia. Access to routine ultrasound could be improved for women in rural and lower-income areas.

6.
J Perioper Pract ; : 17504589241278472, 2024 Sep 20.
Article in English | MEDLINE | ID: mdl-39305059

ABSTRACT

BACKGROUND: Females undergoing laparoscopic gynaecological surgeries have a high incidence of postoperative nausea and vomiting. Apart from the established risk factors, hormonal, psychological, genetic and ethnic factors may also contribute to postoperative nausea and vomiting. This study aimed to evaluate the relationship between preoperative anxiety and serum oestrogen level with postoperative nausea and vomiting in patients undergoing diagnostic laparoscopy - hysteroscopy for infertility. METHODS: In total, 100 female patients, between the ages of 20-40 years, undergoing diagnostic laparoscopy - hysteroscopy for infertility were recruited for this study. Preoperative anxiety level was assessed using Depression, Anxiety and Stress Scale-21 (DASS-21) Questionnaire. Serum oestrogen samples were taken before anaesthesia. Postoperative nausea and vomiting grading was rated with 0-3 Likert-type scale. An association of anxiety and oestrogen levels to postoperative nausea and vomiting was done. RESULTS: The analysis between median DASS 21 scores to postoperative nausea and vomiting grading showed no association between DASS 21 scores and postoperative nausea and vomiting grades. Comparing the mean oestrogen levels in patients among each grade of postoperative nausea and vomiting showed no significant difference in the mean oestrogen levels. CONCLUSION: Our study did not find evidence of a significant association between serum oestrogen levels, preoperative anxiety, and postoperative nausea and vomiting.

7.
BMJ Open ; 14(9): e082424, 2024 Sep 10.
Article in English | MEDLINE | ID: mdl-39260849

ABSTRACT

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) are one of the leading causes of maternal morbidity and mortality. The risk of developing cardiovascular diseases following HDP is high. Arterial stiffness is a prognostic indicator for cardiovascular disease in the general population, and it is elevated during pregnancy in women with HDP. No systematic reviews have been conducted to determine if arterial stiffness remains elevated beyond puerperium in these women with HDP. METHODS AND ANALYSIS: We will conduct a systematic literature search in the following electronic databases: Medline, PubMed, Embase, Cochrane Library, Google Scholar, Web of Science and CINAHL. The review will consider studies that investigate arterial stiffness in women who had HPD and are between 43 days and 10 years postdelivery and under 60 years of age. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. Estimates of mean ± SD for arterial stiffness indices (cfPWV, AIx and AIx@75) for the women in the included studies will be obtained. For studies where the estimates were reported as the median and IQR, approximate estimates of mean ± SD will be calculated by using the low and high end of the range, median and sample size. Data from the individual studies will be pooled by use of a random-effects model. The risk of bias assessment will be assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Quality Assessment Scale as appropriate. Sources of heterogeneity will be explored by sensitivity and subgroup analyses. ETHICS AND DISSEMINATION: No ethics approval is required as only published data will be used in this study. The research study's outcomes will be shared through scientific conferences and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023461867.


Subject(s)
Hypertension, Pregnancy-Induced , Postpartum Period , Vascular Stiffness , Female , Humans , Pregnancy , Hypertension, Pregnancy-Induced/diagnosis , Hypertension, Pregnancy-Induced/physiopathology , Research Design , Systematic Reviews as Topic , Vascular Stiffness/physiology
8.
Sci Prog ; 107(3): 368504241278476, 2024.
Article in English | MEDLINE | ID: mdl-39285783

ABSTRACT

This review article discusses neonatal lupus syndrome (NLS), an immune-mediated disease caused by maternal antibodies. Maternal antibodies in the fetal circulation are mostly but not always protective. NLS is a disease caused by pathogenic maternal autoantibodies in the fetal circulation. The passive immunization of the fetus by NLS-causing maternal antibodies may occur in the absence of a previously known maternal systemic autoimmune rheumatic disease (SARD). Screening for NLS-related antibodies in patients with related SARD or those in whom there is a risk of NLS including first-degree relatives should occur before pregnancy. This screening is best performed as part of a collaborative relationship between obstetrics and rheumatology. Pregnancy preparations in those with SARD include transitioning to pregnancy-safe medications. The symptoms of NLS range from minor skin rashes to fetal demise from heart block. Fetal screening allows for maternal therapeutic interventions that may be beneficial, as well as the use of fetal pacemakers in the more severe cases that include cardiac NLS.


Subject(s)
Lupus Erythematosus, Systemic , Humans , Lupus Erythematosus, Systemic/immunology , Lupus Erythematosus, Systemic/congenital , Lupus Erythematosus, Systemic/diagnosis , Pregnancy , Infant, Newborn , Female , Autoantibodies/immunology , Autoantibodies/blood , Pregnancy Complications/immunology
9.
Cureus ; 16(8): e67385, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39310397

ABSTRACT

Intrahepatic cholestasis of pregnancy (ICP) is a prevalent and reversible liver disorder that occurs during pregnancy. It is primarily characterized by itching, especially on the palms and soles, and elevated levels of transaminases and bile acids. Some patients may also exhibit hyperbilirubinemia. This condition generally has a good maternal prognosis. The patient, in this case, presented with severe itching, elevated liver enzymes and bile acids, and an ultrasound indicated placenta previa. Uniquely, she experienced an episode of seizure and high blood pressure following surgery. This case report underscores the need for vigilant monitoring of patients with ICP, not only during pregnancy due to the risk of adverse perinatal outcomes but also for antenatal and postpartum complications.

10.
J Clin Invest ; 2024 Sep 19.
Article in English | MEDLINE | ID: mdl-39312740

ABSTRACT

Tumor-associated macrophages (TAMs) and myeloid-derived suppressor cells (MDSCs) play a critical role in resistance to immunotherapy. In this study, we identified epidermal growth factor-like 6 (Egfl6) as a new regulator of myeloid cell functions. Our analyses indicated that Egfl6, via binding with ß3 integrins and activation of p38 and SYK signaling, acts as a chemotactic factor for myeloid cells migration and promotes their differentiation towards an immunosuppressive state. In syngeneic mouse models of ovarian cancer (OvCa), tumor expression of Egfl6 increased the intra-tumoral accumulation of polymorphonuclear (PMN) MDSCs and TAMs and their expression of immunosuppressive factors, including CXCL2, IL-10 and PD-L1. Consistent with this, in an immune 'hot' tumor model, Egfl6 expression eliminated response to a-PD-L1 therapy, while Egfl6 neutralizing antibody decreased the accumulation of tumor-infiltrating CD206+ TAMs and PMN-MDSCs and restored the efficacy of a-PD-L1 therapy. Supporting a role in human tumors, in human OvCa tissue samples, areas of high EGFL6 expression co-localized with myeloid cell infiltration. scRNAseq analyses revealed a correlation between EGFL6 and immune cell expression of immunosuppressive factors. Our data provide mechanistic insights into the onco-immunologic functions of EGFL6 in mediating tumor immune suppression and identified EGFL6 as a potential novel therapeutic target to enhance immunotherapy in OvCa patients.

11.
J Cancer Educ ; 2024 Sep 24.
Article in English | MEDLINE | ID: mdl-39313627

ABSTRACT

Obstetrics and Gynecology (Ob/Gyn) residents will encounter, screen for, and diagnose gynecologic malignancies. This survey assessed residents' confidence in providing NCCN Guidelines-based care to Gynecologic Oncology patients of differing racial/ethnic backgrounds and insurance statuses while accounting for residents' backgrounds. An anonymous, novel Qualtrics survey was disseminated to current US Ob/Gyn residents, with multiple-choice questions about subject demographics and Likert scale questions about their readiness to care for diverse patients. Differences in responses between racial groups were analyzed using the Kruskal-Wallis Rank Sum test. Differences in responses between ethnic groups were evaluated using the Wilcoxon Rank Sum test. Regardless of their backgrounds, residents feel "somewhat prepared" to care for diverse patients. There was no statistical between ethnic groups regarding confidence in caring for racial minorities or insurance types. Similarly, there was no statistical difference between racial groups regarding caring for racial minorities, but a difference did exist for insurance types (p = 0.027). No significant racial/ethnic differences were found in opinions on trial enrollment or chemotherapy delays, though most residents agreed that racial/ethnic minorities face delays in chemotherapy. Finally, resident ethnicity and race both impacted resident perceptions of difficulties for Medicaid and minority patients in obtaining non-operative gynecologic care (p = 0.044; p = 0.017) and scheduling outpatient appointments (p = 0.016; p = 0.032). Ob/Gyn residents feel prepared to provide NCCN Guidelines-based care to socioeconomically diverse patients with gynecologic malignancies, though differences exist when accounting for residents' racial/ethnic backgrounds. These results reflect the importance of emphasizing on culturally competent care in residency, particularly for patients with cancer.

12.
J Obstet Gynaecol Can ; : 102659, 2024 Sep 09.
Article in English | MEDLINE | ID: mdl-39260619

ABSTRACT

BACKGROUND: Guidelines recommending deferred cord clamping (DCC), delaying cord clamping for at least 30 seconds post-birth, have shown significant benefits in preterm singleton births. However, evidence supporting DCC in twins is scarce due to limited trial data, leading to practice variations. OBJECTIVE: This study aims to assess current reported DCC practices for twin pregnancies in tertiary hospitals across Canada. METHODS: A web-based survey was distributed to neonatologists and obstetrician investigators associated with the Canadian Neonatal and Preterm Birth Networks (CNN/CPTBN) operating maternity and neonatal units. RESULTS: Site response rate was 93% (28/30 sites), with 83% (25/30) for neonatologists and 56% (17/30) for obstetricians. The majority had a local protocol for twin pregnancies (obstetricians 13/17, neonatologists 21/25). While all centers practiced DCC in dichorionic-diamnionic twins, a difference was noted for mono-di twins, with 56% of neonatologists and 65% of obstetricians performing DCC. During cesarean delivery, most obstetricians (76.5%) placed the firstborn on the mother's thighs. Neonatologists varied in their practices, with 32% placing the baby on the mother's abdomen, 32% on the mother's thighs, and 28% holding the baby at the height of the perineum. Divergent opinions were observed regarding contraindications, including risks of postpartum hemorrhage and velamentous cord insertion. CONCLUSION: DCC is reported to be practiced in most twin deliveries among CNN/CPTBN centers. However, there are wide variations in practice, especially concerning the characteristics of the twins in which DCC is performed. Future research should investigate optimal cord clamping management in twins to standardize practices and maximize benefits. CONTEXTE: Les directives recommandant le clampage retardé du cordon (CRC), qui consiste à retarder le clampage du cordon d'au moins 30 secondes après la naissance, ont montré des bénéfices significatifs chez le prématuré d'une grossesse monofœtale. Cependant, les données probantes appuyant le CRC en contexte de jumeaux sont rares en raison du nombre limité de données d'essais, ce qui entraîne des variations dans la pratique. OBJECTIF: Cette étude vise à évaluer les pratiques actuelles de CRC pour les grossesses gémellaires dans les hôpitaux tertiaires partout au Canada. MéTHODES: Un sondage en ligne a été distribué aux néonatologistes et aux obstétriciens-chercheurs associés aux réseaux canadiens de néonatalogie et de naissance prématurée (CNN/CPTBN) qui gèrent des unités de néonatalogie et de maternité. RéSULTATS: Le taux de réponse des centres était de 93 % (28/30 centres), à savoir 83 % (25/30) pour les néonatologistes et 56 % (17/30) pour les obstétriciens. La majorité d'entre eux disposaient d'un protocole local pour les grossesses gémellaires (13/17 pour les obstétriciens, 21/25 pour les néonatologistes). Même si tous les centres pratiquaient le CRC pour les cas de grossesse bichoriale-biamniotique, une différence a été notée pour les grossesses mono-bi, le CRC étant pratiqué par 56 % des néonatologistes et 65 % des obstétriciens. Lors d'une césarienne, la plupart des obstétriciens (76,5 %) ont placé le premier-né sur les cuisses de la mère. Les pratiques des néonatologistes varient : 32 % placent le bébé sur l'abdomen de la mère, 32 % sur les cuisses de la mère et 28 % le tiennent à la hauteur du périnée. Des opinions divergentes ont été observées concernant les contre-indications, notamment les risques d'hémorragie post-partum et l'insertion vélamenteuse du cordon ombilical. CONCLUSION: Le CRC est pratiqué dans la plupart des accouchements gémellaires dans les centres du CNN/CPTBN. Cependant, la pratique varie considérablement, notamment en ce qui concerne les caractéristiques des jumeaux où le CRC est effectué. Les recherches futures devraient porter sur la gestion optimale du clampage du cordon chez les jumeaux afin de normaliser les pratiques et de maximiser les bénéfices.

13.
J Clin Invest ; 2024 Sep 12.
Article in English | MEDLINE | ID: mdl-39264721

ABSTRACT

Proper action of the female sex steroids, 17ß-estradiol (E2) and progesterone (P4) on endometrium is essential for fertility. Beyond its role in regulating the cell cycle, cyclin A2 (CCNA2) also mediates E2 and P4 signaling in vitro, but a potential role in modulating steroid action for proper endometrial tissue development and function is unknown. To fill this gap in our knowledge, we examined human endometrial tissue from fertile and infertile women for CCNA2 expression and correlated this with pregnancy outcome. Functional assessment of CCNA2 was validated in vivo using a conditional Ccna2 uterine deficient mouse model while in vitro function was assessed using human cell culture models. We found that CCNA2 expression was significantly reduced in endometrial tissue, specifically the stromal cells, from women undergoing in vitro fertilization who failed to achieve pregnancy. Conditional deletion of Ccna2 from mouse uterine tissue resulted in an inability to achieve pregnancy which appears to be due to alterations in the process of decidualization, which was confirmed using in vitro models. From these studies, we conclude that CCNA2 expression during the proliferative/regenerative stage of the menstrual cycle acts as a safeguard allowing for proper steroid responsiveness, decidualization and pregnancy. When CCNA2 expression levels are insufficient there is impaired endometrial responsiveness, aberrant decidualization and loss of pregnancy.

14.
Best Pract Res Clin Obstet Gynaecol ; 97: 102546, 2024 Sep 03.
Article in English | MEDLINE | ID: mdl-39265229

ABSTRACT

The role of genetic testing within maternal medicine is expanding. Advancing technology and the increasing availability of genetic testing have seen more patients receiving a genetic diagnosis than ever before. Improved healthcare and understanding of these rare diseases means that many patients are living well into their reproductive years and starting families. Individual diseases are considered by their patterns of inheritance i.e. autosomal recessive, autosomal dominant and chromosomal diseases. This chapter specifically addresses the following examples and outlines an approach to pre-conceptual and pregnancy management; autosomal recessive (cystic fibrosis, phenylketonuria), autosomal dominant (osteogenesis imperfecta, vascular Ehlers-Danlos syndrome) and chromosomal (Turner syndrome). For many rare and ultrarare genetic diseases, there may be no clear guidelines or consensus on the correct management in pregnancy. This chapter seeks to provide a framework for the clinician to use to address the unique needs and risk profile of these patients in pregnancy and pre-conceptually and plan accordingly. The role of pharmacogenetics in maternal medicine, the future of education in genetics for patients and clinicians and the important role of genetic counselling are all considered in this chapter. This overview highlights the important role of genetics in maternal medicine and how this can inform management and planning for the safe care of mother and baby.

15.
J Forensic Leg Med ; 107: 102752, 2024 Sep 06.
Article in English | MEDLINE | ID: mdl-39317098

ABSTRACT

AIM: Medical errors are critical in obstetrics and gynecology (OB/GYN) and contribute to high litigation risks. However, few studies have examined system and diagnostic errors as potential preventable problems. This study aimed to enhance medical safety and reduce litigation by identifying and addressing key contributory factors. METHODS: We retrospectively searched the national Japanese malpractice claims database for OB/GYN cases between 1961 and 2017. We evaluated provider characteristics and background information of the patients (plaintiffs). The main outcome was litigation (acceptance or rejection) in the final judgment. Using multivariable logistic regression models, we assessed the associations between medical malpractice variables (system and diagnostic errors, facility size, situation, place, time, and clinical outcomes) and litigation outcomes (acceptance). RESULTS: Overall, 344 malpractice claims were analyzed. Among these, 277 (80.5 %) were obstetric, and 67 (19.5 %) were gynecological. Of the obstetric cases, 193 were perinatal, and 84 were maternal. Malpractice claims were accepted (OB-GYN losses) in 185 cases (53.8 %). In multivariable analyses, system errors (odds ratio 97.4, 95 % confidence interval 35.2-270.0), diagnostic errors (odds ratio 4.5, 95 % confidence interval 1.8-11.3), and clinic (odds ratio 2.7, 95 % confidence interval 1.2-4.8) had a significant statistical association with accepted claims. CONCLUSION: System errors, diagnostic errors, and clinics were significantly associated with acceptance claims. These findings underscore the necessity of addressing modifiable factors at the physician level and within the healthcare management system to enhance patient safety and reduce litigation risks, thereby ensuring a safer and more reliable healthcare environment for patients and medical professionals.

16.
J Surg Educ ; 81(11): 1778-1783, 2024 Sep 23.
Article in English | MEDLINE | ID: mdl-39317123

ABSTRACT

OBJECTIVE: To evaluate the impact of virtual interviews on geographic trends for applicants and programs in the obstetrics and gynecology (OBGYN) resident match. DESIGN: Cross-sectional study of a random 50% sample of all OBGYN residency programs listed by the Accreditation Council for Graduate Medical Education (ACGME) for the 2023 to 2024 academic year. Data collected from each program included geographic location, number of residents per year, and total number of residents. Residents were categorized into 4 mutually exclusive geographic match categories: matched into the same institution, matched into same state (but different institution), matched into the same US Census region but a different state/institution, or matched into a different US Census region. RESULTS: A total of 148 of 295 (50.2%) residency programs were included (known total number of residents = 2,928 from four US census regions and Puerto Rico). Most programs were considered small (≤16 residents; n = 52, 35.1%). In general, 43.9% (1148 of 2617) residents matched in a different region from their medical school training. For the primary outcome, no differences in the geographic placement in the previrtual (2020) and virtual application cycles (2021-2023) were observed (p = 0.51). When analyzed by program size or program region, there was no difference in the geographic placement in the previrtual and virtual application cycles. CONCLUSIONS: This study suggests that the virtual interview process did not demonstrate an impact on geographical placement of OBGYN residents, regardless of the size of the residency program or the program's geographic region.

17.
BMJ Case Rep ; 17(9)2024 Sep 24.
Article in English | MEDLINE | ID: mdl-39317484

ABSTRACT

A neonate presented to a tertiary clinic with blisters and erosions over his trunk and extremities. The mother had multiple erosions with crusts affecting the scalp, oral cavity and trunk present since the first trimester and worse since delivery. Skin biopsy for histopathology and direct immunofluorescence confirmed pemphigus vulgaris (PV) in the mother. Indirect immunofluorescence assays for serum antibodies against desmogleins 1 and 3 were positive in both mother and baby confirming a diagnosis of neonatal PV. The baby's lesions healed spontaneously within 2 weeks, and the mother was clear at 2 months following treatment with rituximab.


Subject(s)
Pemphigus , Rituximab , Humans , Pemphigus/diagnosis , Pemphigus/drug therapy , Pemphigus/pathology , Infant, Newborn , Female , Rituximab/therapeutic use , Male , Pregnancy , Immunologic Factors/therapeutic use , Adult , Pregnancy Complications/drug therapy , Pregnancy Complications/diagnosis
18.
BMJ Open ; 14(9): e091176, 2024 Sep 24.
Article in English | MEDLINE | ID: mdl-39317491

ABSTRACT

INTRODUCTION: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use. METHODS AND ANALYSIS: In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org. ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT06445946.


Subject(s)
Diabetes, Gestational , Hypoglycemic Agents , Insulin , Metformin , Humans , Metformin/therapeutic use , Metformin/administration & dosage , Diabetes, Gestational/drug therapy , Pregnancy , Female , Hypoglycemic Agents/therapeutic use , Hypoglycemic Agents/administration & dosage , Insulin/therapeutic use , Insulin/administration & dosage , United States , Pregnancy Outcome , Comparative Effectiveness Research , Multicenter Studies as Topic , Adult
20.
BMJ Open ; 14(9): e090503, 2024 Sep 10.
Article in English | MEDLINE | ID: mdl-39260859

ABSTRACT

INTRODUCTION: Undetected high-risk conditions in pregnancy are a leading cause of perinatal mortality in low-income and middle-income countries. A key contributor to adverse perinatal outcomes in these settings is limited access to high-quality screening and timely referral to care. Recently, a low-cost one-dimensional Doppler ultrasound (1-D DUS) device was developed that front-line workers in rural Guatemala used to collect quality maternal and fetal data. Further, we demonstrated with retrospective preliminary data that 1-D DUS signal could be processed using artificial intelligence and deep-learning algorithms to accurately estimate fetal gestational age, intrauterine growth and maternal blood pressure. This protocol describes a prospective observational pregnancy cohort study designed to prospectively evaluate these preliminary findings. METHODS AND ANALYSIS: This is a prospective observational cohort study conducted in rural Guatemala. In this study, we will follow pregnant women (N =700) recruited prior to 18 6/7 weeks gestation until their delivery and early postpartum period. During pregnancy, trained nurses will collect data on prenatal risk factors and obstetrical care. Every 4 weeks, the research team will collect maternal weight, blood pressure and 1-D DUS recordings of fetal heart tones. Additionally, we will conduct three serial obstetric ultrasounds to evaluate for fetal growth restriction (FGR), and one postpartum visit to record maternal blood pressure and neonatal weight and length. We will compare the test characteristics (receiver operator curves) of 1-D DUS algorithms developed by deep-learning methods to two-dimensional fetal ultrasound survey and published clinical pre-eclampsia risk prediction algorithms for predicting FGR and pre-eclampsia, respectively. ETHICS AND DISSEMINATION: Results of this study will be disseminated at scientific conferences and through peer-reviewed articles. Deidentified data sets will be made available through public repositories. The study has been approved by the institutional ethics committees of Maya Health Alliance and Emory University.


Subject(s)
Artificial Intelligence , Fetal Growth Retardation , Pre-Eclampsia , Ultrasonography, Doppler , Humans , Pregnancy , Female , Pre-Eclampsia/diagnostic imaging , Pre-Eclampsia/diagnosis , Guatemala , Fetal Growth Retardation/diagnostic imaging , Fetal Growth Retardation/diagnosis , Prospective Studies , Ultrasonography, Doppler/methods , Rural Population , Ultrasonography, Prenatal/methods , Adult , Gestational Age , Deep Learning , Hypertension
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