Diazepam nasal spray effective in Lennox-Gastaut syndrome

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– A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

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– A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

 

– A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

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Burden of pregnancy-related conditions and severe cardiovascular outcomes: What is the link?

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Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

 

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

 

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

 

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

 

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

 

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Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

 

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

 

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

 

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

 

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

 

Key clinical point: Pregnancy-related cardiometabolic condition of any type was associated with almost a 3-fold higher risk for severe cardiovascular outcomes in the perinatal and postnatal periods, with preeclampsia being associated with a 7-fold higher risk for severe cardiovascular outcomes.

 

Major finding: Risk for severe cardiovascular outcomes was higher in women with vs without pregnancy-related cardiometabolic conditions (adjusted odds ratio [aOR] 3.1; 95% CI 2.7-3.5), with the risk being most prominent for severe preeclampsia (aOR 7.0; 95% CI 5.7-8.6).

 

Study details: This was a post hoc analysis of the deidentified administrative data of 74,510 women who had at least one delivery during the observation period.

 

Disclosures: This study did not declare any specific source of funding. The authors did not declare any conflicts of interest.

 

Source: Marschner S et al. Pregnancy-related cardiovascular conditions and outcomes in a United States Medicaid population. Heart. 2022;108(19):1524-1529 (Sep 12). Doi: 10.1136/heartjnl-2021-320684

 

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Maternal serum sST2 and NT-proBNP levels associated with preeclampsia occurrence in twin pregnancies

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Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

 

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

 

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

 

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Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

 

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

 

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

 

Key clinical point: A significant and independent association was observed between the serum soluble suppression of tumorigenicity 2 (sST2) and N-terminal probrain natriuretic peptide (NT-proBNP) levels during the second or early-third trimester and the onset of preeclampsia in women with twin pregnancies.

 

Major finding: Twin pregnancies with vs without preeclampsia were associated with significantly higher maternal serum levels of sST2 and NT-proBNP in the second and early-third trimesters (both P < .001), with a serum sST2 level of ≥30.7 ng/mL (odds ratio [OR] 8.13; P < .001) and NT-proBNP level of ≥282.2 pg/mL (OR 7.20; P < .001) being independently associated with the occurrence of preeclampsia in twin pregnancies.

 

Study details: Findings are from a longitudinal nested case-control study that included women with dichorionic twin pregnancies from a prospective cohort and compared women with (n = 78) and without (n = 78) preeclampsia.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Xiang Q et al. The correlation between maternal serum sST2, IL-33 and NT-proBNP concentrations and occurrence of pre-eclampsia in twin pregnancies: A longitudinal study. J Clin Hypertens (Greenwich). 2022 (Sep 23). Doi: 10.1111/jch.14579

 

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No neonatal hypothyroidism risk in newborns from mothers investigated for suspected PE using CTPA

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Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

 

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

 

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

 

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

 

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

 

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Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

 

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

 

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

 

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

 

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

 

Key clinical point: Exposure to computed tomography pulmonary angiography (CTPA) in pregnant women with clinically suspected pulmonary embolism (PE) did not lead to neonatal hypothyroidism among newborns.

 

Major finding: In newborns from pregnant women with suspected PE who underwent CTPA, all reported Guthrie levels were below 15 U/mL, with no newborns with neonatal hypothyroidism (0.0%, 95% CI 0.0%-2.5%).

 

Study details: The data come from a prospective management outcome study that evaluated 149 pregnant women (including 14 with twin pregnancies) with suspected PE who underwent CTPA.

 

Disclosures: This study was supported by grants from the Swiss National Foundation for scientific research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis Presidential Grant. The authors declared no conflicts of interest.

 

Source: Righini M et al for the CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 (Aug 11). Doi: 10.1111/jth.15843

 

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Postpartum hemorrhage: Most common maternal morbidity after MTOP at ≥20 weeks’ gestation

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Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at 20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

 

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

 

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

 

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

 

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

 

 

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Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at 20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

 

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

 

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

 

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

 

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

 

 

Key clinical point: Majority of women undergoing medical termination of pregnancy (MTOP) for fetal anomaly at 20 weeks’ gestation had successful unassisted deliveries, but a quarter had common or severe morbidities, with the most common morbidities being postpartum hemorrhage and manual removal of retained placental tissue.

 

Major finding: Overall, 99.0% of women undergoing MTOP for fetal anomaly at ≥20 weeks' gestation had spontaneous vaginal deliveries and 25.5% had a common or severe morbidity, with the most common maternal morbidities being manual removal of retained placental tissue (16.0%) and postpartum hemorrhage (11.1%). Severe maternal morbidity occurred in 1.3% of cases and included amniotic fluid embolism. No maternal deaths were reported.

 

Study details: Findings are from a 10-year retrospective cohort study including 407 women with singleton pregnancies undergoing MTOP for fetal structure or chromosomal anomaly at ≥20 weeks' gestation.

 

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

 

Source: Stewart B et al. Medical termination of pregnancy for fetal anomaly at or beyond 20 weeks' gestation-What are the maternal risks? Prenat Diagn. 2022 (Sep 25). Doi: 10.1002/pd.6241

 

 

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Risk for early-onset preeclampsia with gestational use of antihistamines in allergic women

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Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

 

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

 

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

 

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

 

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837

 

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Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

 

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

 

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

 

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

 

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837

 

Key clinical point: The use vs non-use of antihistamines during later stages (20-36 weeks) of pregnancy increased the risk for early-onset preeclampsia in women with allergy, whereas the risk was insignificant with antihistamine use before (<6 months) or during early stages of (<20 weeks) pregnancy.

 

Major finding: Compared with no antihistamine use, the risk for early-onset preeclampsia (<34 weeks in pregnancy) was high among women with allergy who used antihistamines during late pregnancy (odds ratio [OR] 1.8; 95% CI 1.5-2.2), but was insignificant among those who used antihistamines before or during early pregnancy.

 

Study details: Findings are from a population-based cohort study including 692,487 pregnancies in women with allergy; 101,287 women used antihistamines either before or during early or late pregnancy.

 

Disclosures: This study was funded by the University of Bergen. No conflicts of interest were declared.

 

Source: Sande AK et al. Use of antihistamines before or during pregnancy and risk of early-onset pre-eclampsia in allergic women: A population-based cohort study. BMJ Open. 2022;12(10):e061837 (Oct 7). Doi: 10.1136/bmjopen-2022-061837

 

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Maternal cardiomyopathy tied to adverse perinatal outcomes

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Key clinical point: Pregnancies complicated by cardiomyopathy are more likely to result in adverse perinatal outcomes, including stillbirth, neonatal mortality, preterm birth, and small-for-gestational age neonates compared to healthy pregnancies or those with no other cardiac diseases.

 

Major finding: Pregnancies complicated by cardiomyopathy vs healthy pregnancies were more likely to result in stillbirth (odds ratio [OR] 20.82; P < .00001), neonatal mortality (OR 6.75; P < .00001), preterm birth (OR 5.95; P < .00001), and small-for-gestational age neonates (OR 6.74; P < .00001), with outcomes being similar when compared with pregnancies complicated by other forms of cardiac disease.

 

Study details: Findings are from a systematic review and meta-analysis of 13 observational cohort, case-control, and case-cohort studies including 2,291,024 pregnancies either complicated by cardiomyopathy or other forms of cardiac diseases and those with no cardiac diseases.

 

Disclosures: CE Aiken was supported by the UK Medical Research Council New Investigator Grant and NIHR Cambridge Biomedical Research Centre, UK. The authors declared no conflicts of interest.

 

Source: Eggleton EJ et al. Perinatal outcomes in pregnancies complicated by maternal cardiomyopathy: A systematic review and meta-analysis. Am J Obstet Gynecol. 2022 (Sep 20). Doi: 10.1016/j.ajog.2022.09.025

 

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Key clinical point: Pregnancies complicated by cardiomyopathy are more likely to result in adverse perinatal outcomes, including stillbirth, neonatal mortality, preterm birth, and small-for-gestational age neonates compared to healthy pregnancies or those with no other cardiac diseases.

 

Major finding: Pregnancies complicated by cardiomyopathy vs healthy pregnancies were more likely to result in stillbirth (odds ratio [OR] 20.82; P < .00001), neonatal mortality (OR 6.75; P < .00001), preterm birth (OR 5.95; P < .00001), and small-for-gestational age neonates (OR 6.74; P < .00001), with outcomes being similar when compared with pregnancies complicated by other forms of cardiac disease.

 

Study details: Findings are from a systematic review and meta-analysis of 13 observational cohort, case-control, and case-cohort studies including 2,291,024 pregnancies either complicated by cardiomyopathy or other forms of cardiac diseases and those with no cardiac diseases.

 

Disclosures: CE Aiken was supported by the UK Medical Research Council New Investigator Grant and NIHR Cambridge Biomedical Research Centre, UK. The authors declared no conflicts of interest.

 

Source: Eggleton EJ et al. Perinatal outcomes in pregnancies complicated by maternal cardiomyopathy: A systematic review and meta-analysis. Am J Obstet Gynecol. 2022 (Sep 20). Doi: 10.1016/j.ajog.2022.09.025

 

Key clinical point: Pregnancies complicated by cardiomyopathy are more likely to result in adverse perinatal outcomes, including stillbirth, neonatal mortality, preterm birth, and small-for-gestational age neonates compared to healthy pregnancies or those with no other cardiac diseases.

 

Major finding: Pregnancies complicated by cardiomyopathy vs healthy pregnancies were more likely to result in stillbirth (odds ratio [OR] 20.82; P < .00001), neonatal mortality (OR 6.75; P < .00001), preterm birth (OR 5.95; P < .00001), and small-for-gestational age neonates (OR 6.74; P < .00001), with outcomes being similar when compared with pregnancies complicated by other forms of cardiac disease.

 

Study details: Findings are from a systematic review and meta-analysis of 13 observational cohort, case-control, and case-cohort studies including 2,291,024 pregnancies either complicated by cardiomyopathy or other forms of cardiac diseases and those with no cardiac diseases.

 

Disclosures: CE Aiken was supported by the UK Medical Research Council New Investigator Grant and NIHR Cambridge Biomedical Research Centre, UK. The authors declared no conflicts of interest.

 

Source: Eggleton EJ et al. Perinatal outcomes in pregnancies complicated by maternal cardiomyopathy: A systematic review and meta-analysis. Am J Obstet Gynecol. 2022 (Sep 20). Doi: 10.1016/j.ajog.2022.09.025

 

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FM during shoulder dystocia management associated with higher rates for severe maternal morbidity

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Key clinical point: Management of shoulder dystocia with fetal manipulation (FM) increased the risk for obstetric anal sphincter injury (OASI), with FM being associated with an increased risk for OASI and severe neonatal morbidity.

 

Major finding: Shoulder dystocia managed with vs without FM resulted in significantly higher rates of OASI (21.1% vs 3.8%; odds ratio [OR] 6.72; 95% CI 2.7-15.8) but similar rates of severe neonatal morbidity. FM was associated with the occurrence of OASI (adjusted OR [aOR] 5.3; 95% CI 2.2-12.8) and was the only factor associated with severe neonatal morbidity (aOR 2.3; 95% CI 1.1-4.8).

 

Study details: Findings are from a retrospective observational study including 602 vaginal vertex deliveries in singleton pregnancies, which encountered shoulder dystocia that was managed with (n = 52) or without (n = 550) FM.

 

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

 

Source: Diack B et al. Impact of fetal manipulation on maternal and neonatal severe morbidity during shoulder dystocia management. Arch Gynecol Obstet. 2022 (Sep 23). Doi: 10.1007/s00404-022-06783-y

 

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Key clinical point: Management of shoulder dystocia with fetal manipulation (FM) increased the risk for obstetric anal sphincter injury (OASI), with FM being associated with an increased risk for OASI and severe neonatal morbidity.

 

Major finding: Shoulder dystocia managed with vs without FM resulted in significantly higher rates of OASI (21.1% vs 3.8%; odds ratio [OR] 6.72; 95% CI 2.7-15.8) but similar rates of severe neonatal morbidity. FM was associated with the occurrence of OASI (adjusted OR [aOR] 5.3; 95% CI 2.2-12.8) and was the only factor associated with severe neonatal morbidity (aOR 2.3; 95% CI 1.1-4.8).

 

Study details: Findings are from a retrospective observational study including 602 vaginal vertex deliveries in singleton pregnancies, which encountered shoulder dystocia that was managed with (n = 52) or without (n = 550) FM.

 

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

 

Source: Diack B et al. Impact of fetal manipulation on maternal and neonatal severe morbidity during shoulder dystocia management. Arch Gynecol Obstet. 2022 (Sep 23). Doi: 10.1007/s00404-022-06783-y

 

Key clinical point: Management of shoulder dystocia with fetal manipulation (FM) increased the risk for obstetric anal sphincter injury (OASI), with FM being associated with an increased risk for OASI and severe neonatal morbidity.

 

Major finding: Shoulder dystocia managed with vs without FM resulted in significantly higher rates of OASI (21.1% vs 3.8%; odds ratio [OR] 6.72; 95% CI 2.7-15.8) but similar rates of severe neonatal morbidity. FM was associated with the occurrence of OASI (adjusted OR [aOR] 5.3; 95% CI 2.2-12.8) and was the only factor associated with severe neonatal morbidity (aOR 2.3; 95% CI 1.1-4.8).

 

Study details: Findings are from a retrospective observational study including 602 vaginal vertex deliveries in singleton pregnancies, which encountered shoulder dystocia that was managed with (n = 52) or without (n = 550) FM.

 

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

 

Source: Diack B et al. Impact of fetal manipulation on maternal and neonatal severe morbidity during shoulder dystocia management. Arch Gynecol Obstet. 2022 (Sep 23). Doi: 10.1007/s00404-022-06783-y

 

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ER-Nifedipine prevents severe hypertension in preeclampsia with severe features

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Key clinical point: A dose of 30 mg oral extended-release nifedipine (ER-nifedipine) every 24 hours until delivery effectively reduced the receipt of treatment for acute severe hypertension in individuals with preeclampsia with severe features.

 

Major finding: A significantly lower proportion of individuals who received 30 mg ER-nifedipine vs placebo required 1 dose of acute hypertension therapy for severe blood pressure that sustained for 10 minutes (34.0% vs 55.1%; relative risk 0.62; 95% CI 0.39-0.97). ER-nifedipine vs placebo use led to numerically lower cesarean deliveries (20.8% vs 34.7%) and neonatal intensive care unit admissions (29.1% vs 47.1%).

 

Study details: Findings are from a phase 4 trial including 110 individuals with singleton or twin gestation undergoing labor induction for preeclampsia with severe features who were randomly assigned to receive 30 mg oral ER-nifedipine or placebo every 24 hours until delivery.

 

Disclosures: This study was funded by The Ohio State University Department of Obstetrics and Gynecology. No conflicts of interest were declared.

 

Source: Cleary EM et al. Trial of intrapartum extended-release nifedipine to prevent severe hypertension among pregnant individuals with preeclampsia with severe features. Hypertension. 2022 (Oct 3). Doi: 10.1161/HYPERTENSIONAHA.122.19751

 

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Key clinical point: A dose of 30 mg oral extended-release nifedipine (ER-nifedipine) every 24 hours until delivery effectively reduced the receipt of treatment for acute severe hypertension in individuals with preeclampsia with severe features.

 

Major finding: A significantly lower proportion of individuals who received 30 mg ER-nifedipine vs placebo required 1 dose of acute hypertension therapy for severe blood pressure that sustained for 10 minutes (34.0% vs 55.1%; relative risk 0.62; 95% CI 0.39-0.97). ER-nifedipine vs placebo use led to numerically lower cesarean deliveries (20.8% vs 34.7%) and neonatal intensive care unit admissions (29.1% vs 47.1%).

 

Study details: Findings are from a phase 4 trial including 110 individuals with singleton or twin gestation undergoing labor induction for preeclampsia with severe features who were randomly assigned to receive 30 mg oral ER-nifedipine or placebo every 24 hours until delivery.

 

Disclosures: This study was funded by The Ohio State University Department of Obstetrics and Gynecology. No conflicts of interest were declared.

 

Source: Cleary EM et al. Trial of intrapartum extended-release nifedipine to prevent severe hypertension among pregnant individuals with preeclampsia with severe features. Hypertension. 2022 (Oct 3). Doi: 10.1161/HYPERTENSIONAHA.122.19751

 

Key clinical point: A dose of 30 mg oral extended-release nifedipine (ER-nifedipine) every 24 hours until delivery effectively reduced the receipt of treatment for acute severe hypertension in individuals with preeclampsia with severe features.

 

Major finding: A significantly lower proportion of individuals who received 30 mg ER-nifedipine vs placebo required 1 dose of acute hypertension therapy for severe blood pressure that sustained for 10 minutes (34.0% vs 55.1%; relative risk 0.62; 95% CI 0.39-0.97). ER-nifedipine vs placebo use led to numerically lower cesarean deliveries (20.8% vs 34.7%) and neonatal intensive care unit admissions (29.1% vs 47.1%).

 

Study details: Findings are from a phase 4 trial including 110 individuals with singleton or twin gestation undergoing labor induction for preeclampsia with severe features who were randomly assigned to receive 30 mg oral ER-nifedipine or placebo every 24 hours until delivery.

 

Disclosures: This study was funded by The Ohio State University Department of Obstetrics and Gynecology. No conflicts of interest were declared.

 

Source: Cleary EM et al. Trial of intrapartum extended-release nifedipine to prevent severe hypertension among pregnant individuals with preeclampsia with severe features. Hypertension. 2022 (Oct 3). Doi: 10.1161/HYPERTENSIONAHA.122.19751

 

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Slowly improving glycemic control following gestational diabetes increases risk for shoulder dystocia

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Key clinical point: Risk for shoulder dystocia was higher among women with gestational diabetes who showed a slowly improving glycemic control trajectory, highlighting the need for interventions that help achieve glycemic targets early after the diagnosis of gestational diabetes.

 

Major finding: Compared with women showing rapid improvements to attain optimal glycemic control, the risk for shoulder dystocia was higher among women showing slow improvements to attain suboptimal glycemic control (adjusted relative risk [aRR] 1.41; 95% CI 1.12-1.78) and was lower among women with stably optimal glycemic control from diagnosis to delivery (aRR 0.75; 95% CI 0.61-0.92).

 

Study details: Findings are from a population-based longitudinal cohort study including 26,774 women with gestational diabetes who received prenatal care.

 

Disclosures: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and other sources. The authors did not declare any conflicts of interest.

 

Source: Chehab RF et al. Glycemic control trajectories and risk of perinatal complications among individuals with gestational diabetes. JAMA Netw Open. 2022;5(9):e2233955 (Sep 29). Doi: 10.1001/jamanetworkopen.2022.33955

 

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Key clinical point: Risk for shoulder dystocia was higher among women with gestational diabetes who showed a slowly improving glycemic control trajectory, highlighting the need for interventions that help achieve glycemic targets early after the diagnosis of gestational diabetes.

 

Major finding: Compared with women showing rapid improvements to attain optimal glycemic control, the risk for shoulder dystocia was higher among women showing slow improvements to attain suboptimal glycemic control (adjusted relative risk [aRR] 1.41; 95% CI 1.12-1.78) and was lower among women with stably optimal glycemic control from diagnosis to delivery (aRR 0.75; 95% CI 0.61-0.92).

 

Study details: Findings are from a population-based longitudinal cohort study including 26,774 women with gestational diabetes who received prenatal care.

 

Disclosures: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and other sources. The authors did not declare any conflicts of interest.

 

Source: Chehab RF et al. Glycemic control trajectories and risk of perinatal complications among individuals with gestational diabetes. JAMA Netw Open. 2022;5(9):e2233955 (Sep 29). Doi: 10.1001/jamanetworkopen.2022.33955

 

Key clinical point: Risk for shoulder dystocia was higher among women with gestational diabetes who showed a slowly improving glycemic control trajectory, highlighting the need for interventions that help achieve glycemic targets early after the diagnosis of gestational diabetes.

 

Major finding: Compared with women showing rapid improvements to attain optimal glycemic control, the risk for shoulder dystocia was higher among women showing slow improvements to attain suboptimal glycemic control (adjusted relative risk [aRR] 1.41; 95% CI 1.12-1.78) and was lower among women with stably optimal glycemic control from diagnosis to delivery (aRR 0.75; 95% CI 0.61-0.92).

 

Study details: Findings are from a population-based longitudinal cohort study including 26,774 women with gestational diabetes who received prenatal care.

 

Disclosures: This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases and other sources. The authors did not declare any conflicts of interest.

 

Source: Chehab RF et al. Glycemic control trajectories and risk of perinatal complications among individuals with gestational diabetes. JAMA Netw Open. 2022;5(9):e2233955 (Sep 29). Doi: 10.1001/jamanetworkopen.2022.33955

 

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