Clinical Edge Journal Scan

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Preventive B-Lynch suture seemed safe and effective in preventing excessive maternal hemorrhage in patients at a high risk for postpartum hemorrhage.

Major finding: Overall, 92% of patients who underwent the B-Lynch suture procedure showed no apparent postoperative bleeding within 2 hours after the cesarean section (CS), with 24 patients requiring intraoperative or postoperative blood transfusion, none requiring hysterectomy, and only 1 patient with a twin pregnancy requiring additional treatment because of secondary postpartum hemorrhage 5 days after the CS. Adverse events seemed unrelated to the procedure.

Study details: Findings are from a retrospective study including 663 patients who underwent CS, of which 38 patients underwent the preventive B-Lynch suture procedure before excessive blood loss occurred during CS.

Disclosures: No source of funding was reported. The authors declared no conflicts of interest.

Source: Kuwabara M et al. Effectiveness of preventive B-Lynch sutures in patients at a high risk of postpartum hemorrhage. J Obstet Gynaecol Res. 2022 (Sep 11). Doi: 10.1111/jog.15415

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: Birth injuries are rare with breech vaginal delivery (VD); however, severe birth injury incidence is nearly 2-times higher with breech VD compared with cephalic VD, with brachial plexus palsy (BPP) being more common with breech vs cephalic VD.

Major finding: The incidence of severe birth injury with breech VD, cephalic VD, and cesarean section with breech presentation were 0.76/100, 0.31/100, and 0.059/100 live births, respectively. BPP occurred more frequently with breech VD (0.6% of live births) than with cephalic VD (0.3% of live births).

Study details: The data come from a retrospective study including 650,528 neonates who were delivered by breech VD (0.7%), breech cesarean section (2.6%), or cephalic VD (96.7%).

Disclosures: This study was partly funded by competitive State Research Financing of the Expert Responsibility area of Tampere University Hospital, Finland. The authors declared no conflicts of interest.

Source: Kekki M et al. Birth injury in breech delivery: A nationwide population-based cohort study in Finland. Arch Gynecol Obstet. 2022 (Sep 8). Doi: 10.1007/s00404-022-06772-1

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: A majority of women with preterm preeclampsia showed persistent cardiovascular morbidity at 6 months postpartum, which may have significant implications to long-term cardiovascular health.

Major finding: At 6 months postpartum, diastolic dysfunction, increased total vascular resistance (TVR), and persistent left ventricular remodeling were observed in 61%, 75%, and 41% of women, respectively, with 46% of women with no pre-existing hypertension having de novo hypertension and only 5% of women having a completely normal echocardiogram. A significant association was observed between prolonged preeclampsia duration and increased TVR at 6 months (P = .02).

Study details: Findings are from a sub-study of PICk-UP trial involving 44 postnatal women with preterm preeclampsia who delivered before 37 weeks.

Disclosures: This study was funded by the Medical Research Council, UK. The authors declared no competing financial interests.

Source: Ormesher L et al. Postnatal cardiovascular morbidity following preterm pre-eclampsia: An observational study. Pregnancy Hypertens. 2022;30:68-81 (Aug 17). Doi: 10.1016/j.preghy.2022.08.007

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: The incidence of acute high-risk chest pain (AHRCP) diseases during pregnancy and puerperium has increased consistently over a decade, with advanced maternal age being a significant risk factor.

Major finding: The incidence of AHRCP diseases during pregnancy and puerperium increased from 79.92/100,000 hospitalizations in 2008 to 114.79/100,000 hospitalizations in 2017 (P_trend < .0001), with pulmonary embolism (86.5%) occurring 10-fold and 26-fold more frequently than acute myocardial infarction (9.6%) and aortic dissection (3.3%), respectively. Maternal age over 45 years was a significant risk factor (odds ratio 4.25; 95% CI 3.80-4.75).

Study details: Findings are from an observational analysis of 41,174,101 patients hospitalized for pregnancy and puerperium, of which 40,285 were diagnosed with AHRCP diseases.

Disclosures: This study was supported by the 3-Year Action Plan for Strengthening Public Health System in Shanghai (2020–2022) and other sources. The authors declared no conflicts of interest.

Source: Wu S et al. Incidence and outcomes of acute high-risk chest pain diseases during pregnancy and puerperium. Front Cardiovasc Med. 2022;9:968964 (Aug 11). Doi: 10.3389/fcvm.2022.968964

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Analysis over 2 decades demonstrated trend changes in individual contribution of risk factors for postpartum hemorrhage, with perineal or vaginal tears increasing, large for gestational age neonate decreasing, and other risk factors remaining stable.

Major finding: The incidence of postpartum hemorrhage increased from 0.5% in 1988 to 0.6% in 2014. Among risk factors for postpartum hemorrhage, perineal or vaginal tear demonstrated a rising trend (P = .01), delivery of large for gestational age neonate demonstrated a declining trend (P < .001), and other risk factors, such as preeclampsia, vacuum extraction delivery, and retained placenta, remained stable during the study period.

Study details: Findings are from a population-based, retrospective, nested, case-control study including 285,992 pregnancies, of which 1684 were complicated by postpartum hemorrhage.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Sade S et al. Trend changes in the individual contribution of risk factors for postpartum hemorrhage over more than two decades. Matern Child Health J. 2022 (Aug 24). Doi: 10.1007/s10995-022-03461-y

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: Cesarean delivery, preeclampsia, and uterine rupture were independently associated with a higher risk for intrauterine tamponade failure in women with deliveries complicated by postpartum hemorrhage.

Major finding: Intrauterine tamponade failure rate was 11.1%. The risk for intrauterine tamponade failure was higher in women with cesarean delivery (adjusted odds ratio [aOR] 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-3.9), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0).

Study details: Findings are from a population-based retrospective cohort study including 1761 women with deliveries complicated by postpartum hemorrhage who underwent intrauterine tamponade within 24 hours of postpartum hemorrhage to manage persistent bleeding.

Disclosures: This study did not report any source of funding. No conflicts of interest were declared.

Source: Gibier M et al. Risk factors for intrauterine tamponade failure in postpartum hemorrhage. Obstet Gynecol. 2022;140(3):439-446 (Aug 3). Doi: 10.1097/AOG.0000000000004888

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: The chances of postpartum readmission for hypertension were significantly higher among patients discharged with labetalol vs nifedipine after delivery, irrespective of the severity of their hypertensive disorder of pregnancy.

Major finding: Compared with nifedipine, the chances of postpartum readmission for hypertension were higher with labetalol (adjusted odds ratio [aOR] 1.63, 95% CI 1.43-1.85), with the risk being persistent among patients with mild (aOR 1.57; 95% CI 1.29-1.93) and severe (aOR 1.63, 95% CI 1.43-1.85) hypertensive disorders.

Study details: This study evaluated 24,477 patients who were discharged with nifedipine (36.8%), labetalol (57.7%), or both medications (5.6%) after delivery.

Disclosures: This study did not report any source of funding. DJ Lyell declared receiving payment from various sources.

Source: Do SC et al. Postpartum readmission for hypertension after discharge on labetalol or nifedipine. Obstet Gynecol. 2022;140(4):591-598 (Sep 8). Doi: 10.1097/AOG.0000000000004918

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

Key clinical point: Weekly 3-hour simulation-based training of midwives and doctors on shoulder dystocia (SD) management significantly reduced the incidence of permanent brachial plexus birth injury (BPBI).

Major finding: Despite an increase in the incidence of SD cases (0.1% vs 0.3%; P < .001) and risk factors in pre-training vs post-training period, the incidence of permanent BPBI decreased significantly (0.05% vs 0.02%; P < .001), with the risk for permanent BPBI among those with SD reducing (43.5% vs 6.0%; P < .001) and the rate of successful posterior arm delivery increasing (11.3% vs 23.4%; P = .04) significantly after the implementation of systematic simulation-based training.

Study details: Findings are from a retrospective observational study including 113,785 vertex deliveries performed by a team of doctors and midwives after receiving the weekly 3-hour simulation-based training.

Disclosures: This study was funded by Helsinki University State Research Funding. No conflicts of interest were declared.

Source: Kaijomaa M et al. Impact of simulation training on the management of shoulder dystocia and incidence of permanent brachial plexus birth injury: An observational study. BJOG. 2022 (Aug 10). Doi: 10.1111/1471-0528.17278

Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Diabetes guidelines recommend sodium-glucose transport protein 2 (SGLT2) inhibitors to reduce kidney disease progression in patients with type 2 diabetes (T2D) and moderate-to-severe albuminuric kidney disease on the basis of renal outcomes trials, such as CREDENCE and DAPA-CKD. However, these trials did not include patients who are at low risk for kidney disease progression.

Mozenson and colleagues published a post hoc analysis of the DECLARE-TIMI 58 trial and focused on patients with low kidney risk. They demonstated that dapagliflozin slowed the progression of kidney disease in patients with T2D at high cardiovascular risk, including those who are at low risk for kidney progression. The absolute benefit for slowing kidney progression was much lower in patients with low kidney risk compared with those who are at high or very high risk (number needed to treat 177 vs 13-23). Though dapagliflozin does provide kidney protection across a spectrum of patients with kidney risk, clinicians should consider the level of risk when starting an SGLT2 inhibitor for slowing kidney disease.

SGLT2 inhibitor outcome trials and meta-analyses have mainly shown neutral results for ischemic stroke, except for sotagliflozin vs placebo in the SCORED trial. In this trial, sotagliflozin was shown to reduce total stroke. Recently, in a retrospective longitudinal cohort study of patients with T2D in Taiwan, Lin and colleagues have shown a significant reduction in new onset stroke among those who use SGLT2 inhibitor compared with those who don't. A 15% relative risk reduction in stroke was shown in an analysis that adjusted for age, sex, and duration of T2D, with a similar reduction in a propensity score-matched analysis. Although limited by its observational design, this study suggests that further research should be continued regarding the impact of SGLT2 inhibitors on stroke outcomes.

Severe hypoglycemia is a serious complication of insulin and insulin secretagogue therapy. There have been few studies regarding the association between long-term glycemic variability of A1c and fasting plasma glucose (FPG) and the risk for severe hypoglycemia. Long and colleagues performed a post hoc analysis of the ACCORD study and found that both A1c and FPG variability were associated with a greater risk for severe hypoglycemia in T2D, with FPG being a more sensitive indicator than is A1c variability. Clinicians need to be aware that A1c and FPG variability in insulin- or insulin secretagogue–treated patients with T2D places them at greater risk for severe hypoglycemia and such variability should be considered a potential target of treatment.

Although a higher mean A1c has been linked to diabetes microvascular and macrovascular complications, there is a paucity of data comparing mean A1c and A1c variability and diabetes complications. In a prospective study from Taiwan, Wu and colleagues demonstrated that both mean A1c and A1c variability predicted most diabetes-related complications, with mean A1c being more effective at predicting retinopathy and A1c variability being more effective at predicting a decline in kidney function and cardiovascular and total mortality. Perhaps physicians need to pay more attention to A1c variability and not just the mean A1c over time when assessing an individual and their overall risk for diabetes complications.

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617