Key outcomes in childbirth: Development of a perinatal core outcome set for management of labor and delivery at or near term.

INTRODUCTION: Consistency and relevance of perinatal outcome measures are necessary basics for obstetric research, audit, and clinical counseling. Still, there is an unwarranted variation in reported perinatal outcomes, which impairs research synthesis, validity, and implementation, as well as clinical benchmarking and longitudinal comparisons. The aim of this study was to develop a short-term perinatal (fetal and neonatal) Core Outcome Set to be used in research and quality assurance of management of labor and delivery at or near term. MATERIAL AND METHODS: The methods were guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. The project was prospectively registered on July 2, 2020 in the Core Outcome Measures in Effectiveness Trials (COMET) data base (reference number 1593). A list of potential outcomes was created based on a systematic review of studies evaluating interventions for peripartum management at or near term (≥34 weeks of gestation), including decisions regarding timing and type of onset of labor, intrapartum care, and mode of delivery. The list was entered into a two-round Delphi survey with predefined consensus criteria. Participants (n = 67) included clinicians, researchers, lay persons with experience of childbirth (patient representatives), and other stakeholders. A consensus meeting was held to reach a final agreement. RESULTS: Response rates were 82.1% (55/67) and 92.7% (51/55) for the first and second Delphi rounds, respectively. In total, 17 outcomes were included in the final core outcome set, reflecting mortality, health or morbidity, including asphyxia, central nervous system status, infection, neonatal resuscitation and admission, breastfeeding and mother-infant interaction, operative delivery due to fetal distress, as well as birthweight and gestational age. Two of these outcomes were suggested by patient representatives. CONCLUSIONS: The Swedish Perinatal Core Outcome Set (SPeCOS) study involved a broad circle of relevant stakeholders and reached consensus on a minimal set of perinatal outcomes that should be collected and reported in a standardized way in all future studies on management of labor and delivery at or near term, regardless of the specific population or condition studied. This could improve obstetric research, evidence synthesis, uptake, implementation, and adherence, as well as clinical practice, audit, and comparisons in childbirth care.

Comparing apples and oranges? Variation in choice and reporting of short-term perinatal outcomes of term labor: A systematic review of Cochrane reviews.

Obstetric research is often criticized for using surrogate or combined outcomes with a disproportionately heavy weight of less relevant components. The objective of this methodological systematic review was to assess the choice and reporting of short-term perinatal outcomes for management of labor at or near term and evaluate if there is any need and possibility to harmonize them. A systematic methodological review of Cochrane reviews was performed. The review was registered prospectively at International Prospective Register of Systematic Reviews (PROSPERO), registration number212954. The Cochrane Database of Systematic Reviews was searched by topics and group browsing and by combination of free-text words and standardized subject terms. Cochrane Systematic Reviews with focus on management of labor at or near term, including timing, type of labor onset, mode of delivery and intrapartum care were included while those focused on prenatal care, postnatal interventions, and preterm deliveries were excluded. Prespecified and reported non-prespecified short-term perinatal (foetal and newborn) outcomes were collected. The outcomes were grouped into domains and classified independently by two authors into five prespecified groups regarding their anticipated importance for patients. Outcomes reflecting how a patient feels, functions, and survives were deemed patient-important. We also evaluated whether any of the outcomes were salutogenic (reflecting positive health and well-being rather than illness or adverse event prevention or avoidance). Our search resulted in 806 Cochrane Systematic Reviews, of which we included 141 published between the years 1996 and 2020. We identified 348 unique outcomes, of which 15 (4.3%) were prespecified and 13 (3.7%) were reported in at least 10% of the reviews. Only half of the prespecified outcomes were reported. In total, 88 (25.3%) of the 348 outcomes were classified as patient important, reflecting how a patient feels, functions, and survives. Salutogenic outcomes were rare (3.4%). To conclude, variation in the choice of outcomes for management of term labor as well as the discrepancy between chosen and reported outcomes were large. Harmonization of perinatal outcome measures, based on consensus between researchers, clinicians, and families, is needed.

A step towards better audit: The Robson Ten Group classification system for outcomes other than cesarean section.

INTRODUCTION: The Robson Ten Group Classification System is widely used for the audit of cesarean section (CS) rates. However, CS rate alone is a poor quality indicator and should be balanced with other obstetric endpoints. The aim of this study was to evaluate whether Swedish national data on obstetric outcomes other than CS, stratified by the Robson classification, could be analyzed in a useful way. MATERIAL AND METHODS: All births in Sweden from 2017 through 2020 recorded in the nationwide Swedish Pregnancy Register were categorized using the Robson classification with subdivision of some groups. Five outcomes were explored: CS, operative vaginal delivery, postpartum hemorrhage, obstetric anal sphincter injury (OASIS) and Apgar score <7 at 5 minuteutes. Rates of each outcome and contribution of each group to the total outcome rate were calculated. RESULTS: The largest Robson groups were nulliparous and multiparous women with single-term cephalic pregnancies, unscarred uterus and spontaneous labor. Intrapartum CS rates were highest for multiple pregnancies, women with induced labor after previous CS, and nulliparous women with induced labor. Nulliparous women and multiparous women with a previous CS with attempted vaginal birth had the highest operative vaginal delivery and OASIS rates. The postpartum hemorrhage rate was highest for multiple pregnancies and transverse lie, followed by prelabor CS in nulliparous and multiparous women with single-term cephalic pregnancies and unscarred uterus. The highest rates of Apgar score <7 at 5 minute were observed in preterm deliveries, multiple pregnancies, transverse lie and breech presentation. The largest contribution to the total CS rate was made by women with previous CS delivered by prelabor CS, and nulliparous women with induced or spontaneous labor. The largest contribution to all other outcomes was made by nulliparous women with spontaneous or induced labor and, notably, multiparous women with spontaneous labor and unscarred uterus. CONCLUSIONS: The Robson classification provides a useful framework for analyzing CS rates along with rates of operative vaginal delivery, OASIS, postpartum hemorrhage and low Apgar score. Parallel interpretation of several outcomes allows a systematic and multidimensional audit, helpful for families and healthcare professionals, and can be used for comparisons, assessment of trends and subpopulations.

External cephalic version for breech presentation: The guideline landscape and a quest for an optimal approach.

OBJECTIVES: The aim of this study was to illuminate differences in guidelines for external cephalic version (ECV) for breech presentation at or near term and assess their impact on effectiveness of the procedure in order to improve policymaking. STUDY DESIGN: Guidelines from all Swedish ECV providers (hospitals with labor wards, n = 44) were retrieved in 2019 and assessed for similarities and differences. The scoring system based on the identified differences in timing, contraindications and periprocedural care was created. The hospitals were subsequently classified into either restrictive or liberal with regard to ECV. This classification was verified by comparing selection of patients for ECV attempts between the two groups. Our main outcomes were ECV success rate and effectiveness in reducing the remaining breech births and breech cesarean sections. RESULTS: Important differences in timing of ECV, contraindications, periprocedural care, and counselling after failed ECV attempt were found. Two thirds of the hospitals were considered liberal and one third restrictive with regard to ECV. ECV success rate was significantly higher in hospitals with a liberal attitude towards ECV compared with restrictive hospitals (54.0 % vs 50.5 %, p = 0.015). Liberal hospitals had a significantly lower proportion of remaining breech births (2.81 % vs 3.01 %, p = 0.009) and breech cesarean sections at or near term (2.49 % vs 2.72 %, p = 0.003). CONCLUSION: Important differences in ECV guidelines were found. Hospitals with guidelines reflecting a liberal attitude to ECV had a higher ECV success rate, despite a less strict patient selection, and a lower proportion of breech births and breech cesarean sections, which is the aim of ECV. We recommend avoiding routine ill-founded restrictivity in ECV guidelines and support a more nuanced counselling.

Characteristics and short-term obstetric outcomes in a case series of 67 women test-positive for SARS-CoV-2 in Stockholm, Sweden.

INTRODUCTION: The Stockholm region was the first area in Sweden to be hit by the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The national guidelines on the care of women with a positive test for SARS-CoV-2 (detection with polymerase chain reaction [PCR]) recommend individualized antenatal care, mode of delivery based on obstetric considerations, and no routine separation of the mother and the newborn. Breastfeeding is encouraged, and although there is no specific recommendation regarding wearing a face mask to prevent viral transmission to the newborn while nursing, instructions are given to keep high hygiene standards. All studies based on cases tested on hospital admission will capture more women with pregnancy complications than in the general population. Our aim was to describe the clinical characteristics of SARS-CoV-2-positive women and their neonates, and to report short-term maternal and neonatal outcomes. MATERIAL AND METHODS: A retrospective case series with data from medical records including all test-positive women (n = 67) who gave birth to 68 neonates from 19 March to 26 April 2020 in Stockholm, Sweden. Means, proportions and percentages were calculated for clinical characteristics and outcomes. RESULTS: The mean age was 32 years, 40% were nulliparous and 61% were overweight or obese. Further, 15% had diabetes and 21% a hypertensive disease. Seventy percent of the women had a vaginal birth. Preterm delivery occurred in 19% of the women. The preterm deliveries were mostly medically indicated, including two women who were delivered preterm due to severe coronavirus disease 19 (COVID-19), corresponding to 15% of the preterm births. Four women (6%) were admitted to the intensive care unit postpartum but there were no maternal deaths. There were two perinatal deaths (one stillbirth and one neonatal death). Three neonates were PCR-positive for SARS-CoV-2 after birth. CONCLUSIONS: In this case series of 67 women testing positive for SARS-CoV-2 with clinical presentations ranging from asymptomatic to manifest COVID-19 disease, few women presented with severe COVID-19 illness. The majority had a vaginal birth at term with a healthy neonate that was negative for SARS-CoV-2.