'Naming and faming' maternity care providers: A mixed-methods study.

BACKGROUND: Positive benchmarking can serve as a catalyst for maternity care improvement. AIM: To retrospectively benchmark Flemish maternity care providers' qualities, based on women's positive care experiences, and to explore which attributes of the different care providers contribute to these experiences. METHODS: A sequential, two-phased mixed-methods study benchmarking the qualities of the community midwife, the hospital midwife, and the obstetrician. An online questionnaire was used to collect the data among pregnant and postpartum women, who rated their care experiences with the various care providers using the Net Promoter Score. Non-parametric and post hoc tests established the differences between types of clinicians and between antenatal, intrapartum, and postpartum Net Promoter Score mean scores. Content analysis was used to construct a final pool of keywords representing attributes of care professionals, accumulated from the promoters' free text responses. Ranks were assigned to each keyword based on its frequency. FINDINGS: A total of 2385 Net Promoter Scale scores and 1856 free-text responses of 1587 responders were included. The community midwife received the overall highest NPS scores (p < .001). The promoters (n = 1015) assigned community midwives the highest NPS scores (9.67), followed by obstetricians (9.57) and hospital-based midwives (9.51). The distinct benchmarking attributes of community midwives were availability (p < .001), supportiveness (p = .04) and personalised care (p < .001). Being honest (p < .001), empathic (p < .001) and inexhaustible (p = .04) benchmarked hospital midwives. Calmness (p < .001), a no-nonsense approach (p < .001), being humane (p = .01) and comforting (p = .02) benchmarked obstetricians. DISCUSSION/CONCLUSION: The findings indicate that all care providers are highly valued, but community midwives are ranked the highest. The distinct differences between the care professionals can serve as exemplary performance for professional development and shape the profiles of maternity care professionals.

A survey of screening and support systems for socially high-risk pregnancies at obstetric facilities in Japan.

AIM: To clarify the state of screening and support systems for socially high-risk pregnant women at obstetric facilities across Japan and identify the characteristics of facilities related to the implementation of screening. METHODS: This cross-sectional study used a self-administered questionnaire. Participants were managers of hospitals, clinics, and midwifery birth centers handling deliveries in 47 prefectures across Japan. The questionnaire comprised items regarding the characteristics of participants and their facilities, service provision related to socially high-risk women available at the facility, the number of specified pregnant women (tokutei ninpu) per year, methods of screening, and support systems within the obstetric facilities. Descriptive statistics and multivariate logistic regression analysis were performed using IBM-SPSS version 24 for the association between facility characteristics and screening practices for socially high-risk pregnant women. RESULTS: Valid responses were received from 716 of 2512 obstetric facilities. Rates of specified expectant mothers per annual number of deliveries were identified as follows: perinatal medical centers (2.7%), general hospitals (1.6%), obstetrics and gynecology hospitals (1.0%), and clinics (0.8%). A total of 426 facilities (60.6%) reported screening all expectant mothers to identify socially high-risk pregnant women. Multiple logistic regression analysis revealed that facility characteristics and service/care provision related to screening practices included availability of in-hospital midwife-led care and in-hospital midwifery clinics (adjusted odds ratio 1.61; 95% CI [1.30, 1.47]), one-on-one care by midwife (1.73; 95% CI [1.15, 2.59]), multidisciplinary meetings within the facility (1.70; 95% CI [1.14, 2.56]), follow-up support systems after discharge (1.90; 95% CI [1.17, 3.09]), and participation in the regional council for children in need of protection (2.33; 95% CI [1.13, 4.81]). CONCLUSIONS: Approximately 60% of surveyed obstetric facilities screen for socially high-risk women. Increasing service provision at facilities may be necessary to implement screening.

The United Kingdom and the Netherlands maternity care responses to COVID-19: A comparative study.

BACKGROUND: The national health care response to coronavirus (COVID-19) has varied between countries. The United Kingdom (UK) and the Netherlands (NL) have comparable maternity and neonatal care systems, and experienced similar numbers of COVID-19 infections, but had different organisational responses to the pandemic. Understanding why and how similarities and differences occurred in these two contexts could inform optimal care in normal circumstances, and during future crises. AIM: To compare the UK and Dutch COVID-19 maternity and neonatal care responses in three key domains: choice of birthplace, companionship, and families in vulnerable situations. METHOD: A multi-method study, including documentary analysis of national organisation policy and guidance on COVID-19, and interviews with national and regional stakeholders. FINDINGS: Both countries had an infection control focus, with less emphasis on the impact of restrictions, especially for families in vulnerable situations. Differences included care providers' fear of contracting COVID-19; the extent to which community- and personalised care was embedded in the care system before the pandemic; and how far multidisciplinary collaboration and service-user involvement were prioritised. CONCLUSION: We recommend that countries should 1) make a systematic plan for crisis decision-making before a serious event occurs, and that this must include authentic service-user involvement, multidisciplinary collaboration, and protection of staff wellbeing 2) integrate women's and families' values into the maternity and neonatal care system, ensuring equitable inclusion of the most vulnerable and 3) strengthen community provision to ensure system wide resilience to future shocks from pandemics, or other unexpected large-scale events.

[How Common are Complementary Medicine Procedures in Bavarian Acute Care Hospitals? Results of A Bavarian-wide Website Screening]. / Wie verbreitet sind komplementärmedizinische Verfahren in bayerischen Krankenhäusern? Eine Vollerhebung für Bayern mittels Website-Screening.

BACKGROUND: In Germany, complementary medicine is used by up to 62% of patients, but type and extent of in-patient complementary care are not known. The objective of this study was, therefore, to conduct a survey on complementary medicine procedures in Bavarian acute care hospitals by screening the websites of all respective facilities in order to cover a broad range of complementary procedures. METHODS: In 2020, an independent and comprehensive website screening of all 389 Bavarian acute hospitals, including all departments, was conducted by two independent raters. Complementary medicine procedures offered were analysed in total as well as separately by specialty. RESULTS: Among all 389 Bavarian acute care hospitals, 82% offered at least one and 66% at least three different complementary procedures on their website. Relaxation techniques (52%), acupuncture (44%), massage (41%), movement-, art-, and music therapy (33%, 30%, and 28%), meditative movement therapies like yoga (30%), and aromatherapy (29%) were offered most frequently. Separated by specialty, complementary procedures were most common in psychiatry/psychosomatics (relaxation techniques 69%, movement and art therapy 60% each) at 87%, and in gynaecology/obstetrics (most common acupuncture 64%, homeopathy 60%, and aromatherapy 41%) at 72%. CONCLUSION: The vast majority of Bavarian acute care hospitals also seem to conduct complementary medicine procedures in therapy, especially for psychological indications and in obstetrics and gynaecology, according to the hospital websites. How often these procedures are used in inpatient or outpatient settings as well as evidence on effectiveness of the applied procedures should be investigated in further studies.

Variation of caesarean section rates in Palestinian governmental hospitals.

BACKGROUND: Globally, the increased use of cesarean sections has become prevalent in high-income and low and middle-income countries. In Palestine, the rate had risen from 20.3% in 2014 to 25.1% in 2018. We have rates as high as 35.8% in some governmental hospitals and some as low as 15%. This study aimed to understand better why there is a variation in cesarean rates in governmental hospitals that use the same guidelines. METHODS: A qualitative and quantitative research approach was used. In-depth interviews were conducted with 27 specialists, obstetrics and gynecologists, and midwives in five government hospitals. The hospitals were selected based on the 2017 Annual Health Report reported cesarean section rates. The interview guide was created with the support of specialists and researchers and was piloted. Questions focused mainly on adherence to the obstetric guidelines and barriers to the use, sources of information, training for healthcare providers, the hospital system, and the factors that affect decision-making. Each hospital's delivery records for one month were analyzed to determine the reason for each cesarean section. RESULTS: The results indicated that each governmental hospital at the system level had a different policy on cesarean sections. The National Guidelines were found to be interpreted differently among hospitals. One obstetrician-gynecologist decided on a cesarean section at high-rate hospitals, while low-rate hospitals used collective decision-making with empowered midwives. At the professional level, all hospitals urged the importance of a continuous training program to refresh the medical team knowledge, in-house training of new members joining the hospital, and discussion of cases subjective to obstetrician-gynecologists interpretations. CONCLUSION: Several institutional factors were identified to strengthen the implementation of the national obstetric guidelines. For example, encouraging collective decision-making between obstetrician-gynecologists and midwives, promoting the use of a second opinion, and mandatory training.

Una mirada a la seguridad del ultrasonido en ecotomografía obstétrica / A look at the safety of ultrasound in obstetric echotomography

Resumen Los índices térmico y mecánico son estimadores de riesgo fetal en una ecografía y se deben controlar sus valores minimizando la exposición. Comparamos los valores de los índices térmico y mecánico obtenidos en exámenes ecográficos obstétricos de pacientes gestantes, con el valor recomendado por la comunidad internacional. Se realizó la estimación de estos índices en 421 ecografías obstétricas en 2019. Los valores fueron comparados entre ellos y con el valor recomendado para cada índice y según el modo de visualización (B, Doppler color y Doppler espectral). Del total de la muestra, para el índice térmico en modo Doppler color un 0,24% superó el valor estándar recomendado y en modo Doppler espectral un 2,85%. Para el índice mecánico se sobrepasó el valor recomendado en modo B en un 11,16%, en un 8,08% en modo Doppler color y, por último, en un 0,48% para el modo Doppler espectral. Los índices mecánico y térmico en esta muestra de exámenes ecográficos obstétricos se encuentran en promedio bajo el valor de referencia. Sin embargo, existe un número importante de casos en que se superan las normas, lo que debe ser una voz de alerta para la comunidad médica.

Abstract The thermal and mechanical indices are the best estimators of fetal risk in an ultrasound and their values should be controlled in order to minimize exposure as much as possible. We compared the values of the thermal and mechanical indices obtained in obstetric ultrasound examinations of pregnant patients, with the value recommended by the international community. These indices were estimated in 421 obstetric ultrasounds during 2019. The estimated values were compared with each other and with the recommended value for each index and according to the display mode (B, color Doppler and spectral Doppler). Of the total sample, for the thermal index in color Doppler mode, 0.24% exceeded the recommended standard value and 2.85%. in spectral Doppler mode. For the mechanical index, the recommended value was exceeded in B mode by 11.16%, in 8.08% in color Doppler mode and, finally, by 0.48% for spectral Doppler mode. The mechanical and thermal indices in this sample of obstetric ultrasound examinations are on average below the reference value. However, there is a significant number of cases in which the standards are exceeded, which should be a warning to the medical community.

To what extent is enhanced recovery in surgery used in French obstetrics and gynecology departments?

The objective of the present study was to evaluate the implementation of Enhanced Recovery in Surgery (ERS) in French obstetrics and gynecology departments. To achieve this objective, we drafted an online questionnaire about ERS protocols for cesarian sections and hysterectomies with a benign indication and put a hyperlink on the 'French National College of Gynecologists and Obstetricians' (Collège National des Gynécologues et Obstétriciens Français) website. We obtained 112 analyzable responses. Respectively 66% and 34% of the surveyed departments had established ERS protocols for cesarean sections and for hysterectomies with a benign indication. However, not all of the key ERS items were sufficiently implemented: despite the establishment of written protocols, the degree of compliance with the guidelines issued by the French-Speaking Group for Enhanced Recovery After Surgery (Groupement Francophone de Réhabilitation Améliorée Après Chirurgie) was variable. There are few published data on the implementation of ERS in obstetrics and gynecology departments worldwide. In 2010, the Enhanced Recovery After Surgery® Society issued guidelines and a checklist for an ERS protocol. The literature data suggest that for most surgical disciplines, the main ERS criteria are not well known or not widely applied. ERS protocols are still not widespread in French gynecologic surgery departments. Moreover, the application of some of the major ERS items differs markedly from one ERS program to other, which is likely to reduce the level of effectiveness. It therefore appears to be essential to formalize and promote ERS protocols in gynecological surgery.

Inclusive, supportive and dignified maternity care (SDMC)-Development and feasibility assessment of an intervention package for public health systems: A study protocol.

INTRODUCTION: Mistreatment, discrimination, and poor psycho-social support during childbirth at health facilities are common in lower- and middle-income countries. Despite a policy directive from the World Health Organisation (WHO), no operational model exists that effectively demonstrates incorporation of these guidelines in routine facility-based maternity services. This early-phase implementation research aims to develop, implement, and test the feasibility of a service-delivery strategy to promote the culture of supportive and dignified maternity care (SDMC) at public health facilities. METHODS: Guided by human-centred design approach, the implementation of this study will be divided into two phases: development of intervention, and implementing and testing feasibility. The service-delivery intervention will be co-created along with relevant stakeholders and informed by contextual evidence that is generated through formative research. It will include capacity-building of maternity teams, and the improvement of governance and accountability mechanisms within public health facilities. The technical content will be primarily based on WHO's intrapartum care guidelines and mental health Gap Action Programme (mhGAP) materials. A mixed-method, pre-post design will be used for feasibility assessment. The intervention will be implemented at six secondary-level healthcare facilities in two districts of southern Sindh, Pakistan. Data from multiple sources will be collected before, during and after the implementation of the intervention. We will assess the coverage of the intervention, challenges faced, and changes in maternity teams' understanding and attitude towards SDMC. Additionally, women's maternity experiences and psycho-social well-being-will inform the success of the intervention. EXPECTED OUTCOMES: Evidence from this implementation research will enhance understanding of health systems challenges and opportunities around SDMC. A key output from this research will be the SDMC service-delivery package, comprising a comprehensive training package (on inclusive, supportive and dignified maternity care) and a field tested strategy to ensure implementation of recommended practices in routine, facility-based maternity care. Adaptation, Implementation and evaluation of SDMC package in diverse setting will be way forward. The study has been registered with clinicaltrials.gov (Registration number: NCT05146518).

Study on the use practices and knowledges of French practitioners about the use of intra-uterine devices in early post-partum contraception in France.

OBJECTIVES: Intra-Uterine Device (IUD) insertion is possible in early postpartum. Although this contraception method is recognized and used in lots of country, it seems infrequent and poorly known in France. Our study aims to assess the barriers to the application of this method in France. METHODS: A questionnaire was sent to obstetricians-gynaecologist professionals and midwives in France, through the affiliation to CNGOF (French National College of Obstetricians and Gynecologists) and to CNSF (French National College of Midwives). Questions were focused on the practices and knowledge about the insertion of IUD in early postpartum. RESULTS: four hundred eight practitioners responded. Amongst them, 63% knew about the possibility to use IUDs after a vaginal delivery and 31% knew it could be inserted during cesarean section. Ten percent of them used this method. Most of these practitioners (80% of them) would like to discuss the insertion of an IUD in early postpartum with their patients and 71% would like to perform the insertion themselves after training. Besides, this study shows that contraception is rarely addressed by physicians during the follow-up of pregnancies. Less than 15% of respondents report discussing the topic systematically with the patient during the pregnancy follow during pregnancy follow. CONCLUSION: insertion of IUDs in early postpartum is uncommon in France. The main limitation seems to be a lack of knowledge, but practitioners seem to be interested in this practice. Training courses could be created in order to rase up the adoption of this practice.

Informe de rotación electiva

El presente informe busca dar cuenta del proceso de formación realizado durante la rotación electiva de la licenciada obstétrica Valeria Giacoy Guedes, llevada a cabo entre el 31 de enero y el 29 de abril de 2022 en la Comisión de Salud del Frente de Organizaciones en Lucha (FOL), Organización social de la Regional Zona Norte de la Provincia de Buenos Aires. En lo que sigue se presenta la sede de rotación, la fundamentación sobre la relevancia de esta elección, los objetivos propuestos y las actividades desarrolladas. Por último, una reflexión sobre los aprendizajes logrados y los aportes efectuados desde la disciplina de base (obstetricia), y desde el campo de la educación y promoción de la salud. (AU)

Women's experiences of maternal and newborn health care services and support systems in Buikwe District, Uganda: A qualitative study.

BACKGROUND: Uganda continues to have a high neonatal mortality rate, with 20 deaths per 1000 live births reported in 2018. A measure to reverse this trend is to fully implement the Uganda Clinical Guidelines on care for mothers and newborns during pregnancy, delivery and the postnatal period. This study aimed to describe women's experiences of maternal and newborn health care services and support systems, focusing on antenatal care, delivery and the postnatal period. METHODS: We used triangulation of qualitative methods including participant observations, semi-structured interviews with key informants and focus group discussions with mothers. Audio-recorded data were transcribed word by word in the local language and translated into English. All collected data material were stored using two-level password protection or stored in a locked cabinet. Malterud's Systematic text condensation was used for analysis, and NVivo software was used to structure the data. FINDINGS: Antenatal care was valued by mothers although not always accessible due to transport cost and distance. Mothers relied on professional health workers and traditional birth attendants for basic maternal services but expressed general discontentment with spousal support in maternal issues. Financial dependency, gender disparities, and lack of autonomy in decision making on maternal issues, prohibited women from receiving optimal help and support. Postnatal follow-ups were found unsatisfactory, with no scheduled follow-ups from professional health workers during the first six weeks. CONCLUSIONS: Further focus on gender equity, involving women's right to own decision making in maternity issues, higher recognition of male involvement in maternity care and improved postnatal follow-ups are suggestions to policy makers for improved maternal care and newborn health in Buikwe District, Uganda.

A ten-year review of indications and outcomes of obstetric admissions to an intensive care unit in a low-resource country.

INTRODUCTION: Obstetric intensive care unit admission (ICU) suggests severe morbidity. However, there is no available data on the subject in Ghana. This retrospective review was conducted to determine the indications for obstetric ICU admission, their outcomes and factors influencing these outcomes to aid continuous quality improvement in obstetric care. METHODS: This was a retrospective review conducted in a tertiary hospital in Ghana. Data on participant characteristics including age and whether participant was intubated were collected from patient records for all obstetric ICU admissions from 1st January 2010 to 31st December 2019. Descriptive statistics were presented as frequencies, proportions and charts. Hazard ratios were generated for relations between obstetric ICU admission outcome and participant characteristics. A p-value <0.05 was deemed statistically significant. RESULTS: There were 443 obstetric ICU admissions over the review period making up 25.7% of all ICU admissions. The commonest indications for obstetric ICU admissions were hypertensive disorders of pregnancy (70.4%, n = 312/443), hemorrhage (14.4%, n = 64/443) and sepsis (9.3%, n = 41/443). The case fatality rates for hypertension, hemorrhage, and sepsis were 17.6%, 37.5%, and 63.4% respectively. The obstetric ICU mortality rate was 26% (115/443) over the review period. Age ≥25 years and a need for mechanical ventilation carried increased mortality risks following ICU admission while surgery in the index pregnancy was associated with a reduced risk of death. CONCLUSION: Hypertension, haemorrhage and sepsis are the leading indications for obstetric ICU admissions. Thus, preeclampsia screening and prevention, as well as intensifying antenatal education on the danger signs of pregnancy can minimize obstetric complications. The establishment of an obstetric HDU in CCTH and the strengthening of communication between specialists and the healthcare providers in the lower facilities, are also essential for improved pregnancy outcomes. Further studies are needed to better appreciate the wider issues underlying obstetric ICU admission outcomes. PLAIN LANGUAGE SUMMARY: This was a review of the reasons for admitting severely-ill pregnant women and women who had delivered within the past 42 days to the intensive care unit (ICU), the admission outcomes and risk factors associated with ICU mortality in a tertiary hospital in a low-resource country. High blood pressure and its complications, bleeding and severe infections were observed as the three most significant reasons for ICU admissions in decreasing order of significance. Pre-existing medical conditions and those arising as a result of, or aggravated by pregnancy; obstructed labour and post-operative monitoring were the other reasons for ICU admission over the study period. Overall, 26% of the admitted patients died at the ICU and maternal age of at least 25 years and the need for intubation were identified as risk factors for ICU deaths. Attention must be paid to high blood pressure during pregnancy.

Audit of the appropriateness of the indication for obstetric sonography in a tertiary facility in Ghana.

INTRODUCTION: the use of ultrasound is one of the most vital tools in the management of pregnancies and contributes significantly in improving maternal and child health. Certain indications in pregnancy, guide the obstetrician as to which obstetric scan deems appropriate. The full realization of the benefits of ultrasound depends on whether it is being used appropriately or not, and hence this study aimed at auditing for the appropriate indications for obstetric ultrasound. METHODS: a review of all request forms for obstetric scan between June 2019 and July 2020 was performed to assess the appropriateness of requests for obstetric ultrasound at the Cape Coast Teaching Hospital. The data obtained was analyzed using SPSS (SPSS Inc. Chicago, IL version 20.0). A Chi-squared test of independence was used to check for statistically significant differences between variables at p ≤ 0.05. RESULTS: three hundred and fourteen (314) out of the 527 request forms had clinical indications stated. 174 (81.7%) of requests from Cape Coast Teaching Hospital and 39 (18.3%) from other health centers did not indicate patients clinical history/indication on the request forms. Majority 76 (68.5%) of scans in the first trimester were done without indications/history. Only 29 of requests with clinical history were inappropriate. CONCLUSION: practitioners should be mindful of adequately completing request forms for obstetric investigations since a large number of practitioners do not state the history/indications for the scans. There should be continuous medical education on the importance of appropriate indication for obstetric ultrasound.

Perspectives of Stakeholders About an Early Result Acceptance Program to Complement the Residency Match in Obstetrics and Gynecology.

Importance: The residency application process is flawed, costly, and distracts from the preparation for residency. Disruptive change is needed to improve the inefficiencies in current selection processes. Objective: To determine interest in an early result acceptance program (ERAP) among stakeholders in obstetrics and gynecology (OBGYN), and to estimate its outcome in future application cycles. Design, Setting, and Participants: Surveys of stakeholders in March 2021 queried interest in ERAP across the US. Respondents included OBGYN residency applicants, members of the Association of American Medical Colleges Group on Student Affairs, OBGYN clerkship directors, and residency program directors. Statistical analysis was performed from March to April 2021. Exposures: Respondents completed surveys sent by email from the Association of American Medical Colleges (to OBGYN applicants and members of the Group on Student Affairs), the Association of Professors of Gynecology and Obstetrics (to clerkship directors), and the Council on Resident Education in Obstetrics and Gynecology (to program directors). Main Outcomes and Measures: Applicants and program directors indicated their interest in participating in ERAP, and clerkship directors and members of the Group on Student Affairs indicated their likelihood of recommending ERAP using a 5-point Likert scale. Results: Respondents included 879 (34.0%) of 2579 applicants to OBGYN, 143 (50.3%) of 284 residency program directors, 94 (41.8%) of 225 clerkship directors, and 51 (32.9%) of 155 student affairs deans. The majority of respondents reported being either somewhat or extremely likely to participate in ERAP, including 622 applicants (70.7%) and 87 program directors (60.8%). Interest in ERAP was independent of an applicant's reported board scores, medical school type, race, number of applications submitted, or number of interviews completed. Among program directors, those at university programs were more likely to participate. Stakeholders supported a limit of 3 applications for ERAP, to fill 25% to 50% of residency positions. Estimating the outcome of ERAP using these data suggests 26 280 to 52 560 fewer applications could be submitted in the regular match cycle. Conclusions and Relevance: Stakeholders in the OBGYN application process expressed broad support for the concept of ERAP. The majority of applicants and programs indicated that they would participate, with potentially substantial positive impact on the application process. Careful pilot testing and research regarding implementation are essential to avoid worsening an already dysfunctional application process.

Assessing feasibility and maternal acceptability of a biomechanically-optimized supine birth position: A pilot study.

BACKGROUND: In order to manage a protracted second stage of labor, "eminence-based" birth positions have been suggested by some healthcare professionals. Recent biomechanical studies have promoted the use of an optimized supine birthing position in this setting. However, uncertainty exists regarding the feasibility of this posture, and its acceptability by women. This pilot study primarily aimed to assess these characteristics. OBJECTIVE AND METHODS: In this monocentric prospective study, 20 women with a protracted second stage of labor were asked to maintain a biomechanically-optimized position for at least 20 minutes at full dilatation. This posture is similar to the McRoberts' maneuver. Maintaining the position for 20 minutes or more was considered clinically relevant and indicative of feasibility and acceptability. Satisfaction with the position was assessed using a Visual Analogue Scale (VAS). A sub-group analysis was performed to assess eventual differences between more and less satisfied patients, according to the median of patients' satisfaction scores. RESULTS: Seventeen patients (85%) maintained the optimized position for at least 20 minutes. The median satisfaction score of these participants was 8 (interquartile range: 1) out of 10. No significant differences were found between the two sub-groups (satisfaction score <8 vs satisfaction score ≥8) regarding general and obstetric characteristics, as well as obstetrical and fetal outcomes. CONCLUSION: The optimized position is acceptable and feasible for women experiencing a protracted second stage of labor. Further clinical studies are needed to assess the efficiency of such positions when women undergo an obstructed labor.

Women and babies are dying from inertia: a collaborative framework for obstetrical drug development is urgently needed.

Obstetrical complications, often referred to as the "great obstetrical syndromes," are among the most common global causes of mortality and morbidity in young women and their infants. However, treatments for these syndromes are underdeveloped compared with other fields of medicine and are urgently needed. This current paucity of treatments for obstetrical complications is a reflection of the challenges of drug development in pregnancy. The appetite of pharmaceutical companies to invest in research for obstetrical syndromes is generally reduced by concerns for maternal, fetal, and infant safety, poor definition, and high-risk regulatory paths toward product approval. Notably, drug candidates require large investments for development with an unguaranteed return on investment. Furthermore, the discovery of promising drug candidates is hampered by a poor understanding of the pathophysiology of obstetrical syndromes and their uniqueness to human pregnancies. This limits translational extrapolation and de-risking strategies in preclinical studies, as available for other medical areas, compounded with limited fetal safety monitoring to capture early prenatal adverse reactions. In addition, the ethical review committees are reluctant to approve the inclusion of pregnant women in trials, and in the absence of regulatory guidance in obstetrics, clinical development programs are subject to unpredictable regulatory paths. To develop effective and safe drugs for pregnancy complications, substantial commitment, and investment in research for innovative therapies are needed in parallel with the creation of an enabling ethical, legislative, and guidance framework. Solutions are proposed to enable stakeholders to work with a common set of expectations to facilitate progress in this medical discipline. Addressing this significant unmet need to advance maternal and possibly perinatal health requires the involvement of all stakeholders and specifically patients, couples, and clinicians facing pregnancy complications in the dearth of appropriate therapies. This paper focused on the key pharmaceutical research and development challenges to achieve effective and safe treatments for obstetrical syndromes.