Objective
To assess whether aspirin treatment can be discontinued in pregnancies with normal uterine artery pulsatility index (≤90th percentile) at 24–28 weeks.
Design
Post‐hoc analysis of a clinical ...trial.
Setting
Nine maternity hospitals in Spain.
Population or Sample
Pregnant individuals at high risk of pre‐eclampsia at 11–13 weeks and normal uterine artery Doppler at 24–28 weeks.
Methods
All participants received treatment with daily aspirin at a dose of 150 mg. Participants were randomly assigned, in a 1:1 ratio, either to continue aspirin treatment until 36 weeks (control group) or to discontinue aspirin treatment (intervention group), between September 2019 and September 2021. In this secondary analysis, women with a UtAPI >90th percentile at 24–28 weeks were excluded. The non‐inferiority margin was set at a difference of 1.9% for the incidence of preterm pre‐eclampsia.
Main outcome measures
Incidence of preterm pre‐eclampsia.
Results
Of the 1611 eligible women, 139 were excluded for UtAPI >90th percentile or if UtAPI was not available. Finally, 804 were included in this post‐hoc analysis. Preterm pre‐eclampsia occurred in three of 409 (0.7%) women in the aspirin discontinuation group and five of 395 (1.3%) women in the continuation group (−0.53; 95% CI −1.91 to 0.85), indicating non‐inferiority of aspirin discontinuation.
Conclusions
Discontinuing aspirin treatment at 24–28 weeks in women with a UtAPI ≤90th percentile was non‐inferior to continuing aspirin treatment until 36 weeks for preventing preterm pre‐eclampsia.
Abstract Objective Our aim was to describe ultrasound findings and perinatal outcome after prenatal diagnosis of persistent right umbilical vein (PRUV). Study design We performed a retrospective ...analysis of fetuses with an ultrasound-based prenatal diagnosis of PRUV on record at 2 tertiary centers in Madrid, Spain. We describe clinical, maternal, fetal and perinatal variables for all cases. Results A total of 20,426 fetuses were delivered between the study centers. We detected 22 cases (0.1%) of PRUV. The male-to-female ratio was 1:1. All cases were intrahepatic type and diagnosed during the second and third trimesters (median, 21 weeks; IQR, 20–29 weeks). Doppler ultrasound revealed normal flow in the ductus venosus in all cases. Nine fetuses (40.9%) had additional ultrasound anomalies but no chromosomal abnormalities. Cardiovascular malformations were the most frequently associated congenital anomalies (4/9), followed by neurological malformations (2/9). In 5 of the cases with no concomitant anomalies, the weight of the newborn was below the tenth percentile for gestational age. Gestational development was normal for the remaining newborns. Delivery was unremarkable, and post-natal evolution was favorable. Conclusion Our results point to a potential association between PRUV and other fetal malformations and a very low rate of chromosomal abnormalities. Prenatal diagnosis of PRUV should be followed by detailed anatomical evaluation and echocardiography in order to rule out other structural malformations. The indication for a fetal karyotype study must be made on an individual basis considering PRUV type and other ultrasound findings.
OBJECTIVEThe aim of this study was to assess the incidence of obstetric and neonatal complications in pregnant women with "normal" thyroid-stimulating hormone (TSH) levels in the first trimester ...(group A) and to compare them with those with "slightly elevated" TSH (SET) levels treated with levothyroxine (group B2) or not treated (group B1). METHODSA total of 2375 women who had been performed laboratory tests in their first trimester of pregnancy were detected at our hospital between April 2015 and August 2017. Of these, 469 patients with SET were prospectively detected and randomized to groups B1 (227) and B2 (242). They were monitored prospectively until 6 months after delivery. Data of the control group (n=1906, group A) were retrospectively reviewed. A total of 1745 women were analyzed. Variables assessed included demographic and clinical characteristics and complications of pregnancy and delivery. RESULTSA, B1, and B2 had similar clinical characteristics. There were no statistically significant differences in complications between the three groups during pregnancy, except in that natural deliveries were more common in group A as compared to group B1 (76.8% vs. 68.7%, p 0.017) and group B2 (66.3%), p<0.002). There were more induced deliveries in groups B1 (35.8%), and B2 (36.2%) than in group A (18.4%), p<0.01. Although the recommended TSH level was achieved in the second and third trimesters, no benefit could be found of treatment of SET. CONCLUSIONAlthough there were less natural deliveries and more induced deliveries in patients with SET, treatment with levothyroxine could not reverse this situation, despite achievement of levels considered appropriate in the second and third trimester.
Aspirin reduces the incidence of preterm preeclampsia by 62% in pregnant individuals at high risk of preeclampsia. However, aspirin might be associated with an increased risk of peripartum bleeding, ...which could be mitigated by discontinuing aspirin before term (37 weeks of gestation) and by an accurate selection of individuals at higher risk of preeclampsia in the first trimester of pregnancy.
To determine whether aspirin discontinuation in pregnant individuals with normal soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia.
Multicenter, open-label, randomized, phase 3, noninferiority trial conducted in 9 maternity hospitals across Spain. Pregnant individuals (n = 968) at high risk of preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were recruited between August 20, 2019, and September 15, 2021; of those, 936 were analyzed (intervention: n = 473; control: n = 463). Follow-up was until delivery for all participants.
Enrolled patients were randomly assigned in a 1:1 ratio to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group).
Noninferiority was met if the higher 95% CI for the difference in preterm preeclampsia incidences between groups was less than 1.9%.
Among the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48% (7/473) in the intervention group and 1.73% (8/463) in the control group (absolute difference, -0.25% 95% CI, -1.86% to 1.36%), indicating noninferiority.
Aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio.
ClinicalTrials.gov Identifier: NCT03741179 and ClinicalTrialsRegister.eu Identifier: 2018-000811-26.
Around two percent of asymptomatic women in labor test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Spain. Families and care providers face childbirth with ...uncertainty. We determined if SARS-CoV-2 infection at delivery among asymptomatic mothers had different obstetric outcomes compared to negative patients. This was a multicenter prospective study based on universal antenatal screening for SARS-CoV-2 infection. A total of 42 hospitals tested women admitted for delivery using polymerase chain reaction, from March to May 2020. We included positive mothers and a sample of negative mothers asymptomatic throughout the antenatal period, with 6-week postpartum follow-up. Association between SARS-CoV-2 and obstetric outcomes was evaluated by multivariate logistic regression analyses. In total, 174 asymptomatic SARS-CoV-2 positive pregnancies were compared with 430 asymptomatic negative pregnancies. No differences were observed between both groups in key maternal and neonatal outcomes at delivery and follow-up, with the exception of prelabor rupture of membranes at term (adjusted odds ratio 1.88, 95% confidence interval 1.13-3.11;
= 0.015). Asymptomatic SARS-CoV-2 positive mothers have higher odds of prelabor rupture of membranes at term, without an increase in perinatal complications, compared to negative mothers. Pregnant women testing positive for SARS-CoV-2 at admission for delivery should be reassured by their healthcare workers in the absence of symptoms.
ABSTRACT
Preeclampsia affects up to 4% of pregnancies and is marked by the development of hypertension and proteinuria after 20 weeks of gestation. Complications associated with the disorder include ...preterm birth, fetal growth restriction, placental abruption, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, seizures, and other end organ damage. Aspirin has been shown to reduce the incidence of preterm preeclampsia by 62%. However, it can also lead to peripartum bleeding. Screening for preeclampsia in the first trimester (11 to 13 weeks' gestation) can help identify up to 60% of pregnant individuals who will develop preterm preeclampsia. If preeclampsia screening is conducted during this first trimester, aspirin can be initiated earlier and discontinued earlier to mitigate the risk of peripartum bleeding. In addition, increased soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio is associated with preeclampsia weeks before its clinical onset. An sFlt-1:PlGF of ≤38 has been shown to accurately exclude preeclampsia in pregnant individuals with suspected disease. The aim of this study was to compare the effect of discontinuing aspirin in pregnant individuals at 24 and 28 weeks' gestation with a normal sFlt-1:PlGF ratio of ≤38 against those who continued aspirin treatment until 36 weeks of gestation.
This was an open-label, randomized, noninferiority trial conducted at 9 maternity hospitals in Spain. Included were adult individuals with singleton pregnancies who had live births, were found to be at high risk of preeclampsia at the first-trimester screening, and a normal sFlt-1:PlGF between 24 and 28 weeks of gestation. Participants were randomly assigned 1:1 to discontinue aspirin (intervention group) or continue aspirin treatment (control group). The primary outcome was delivery due to preterm preeclampsia (before 37 weeks' gestation). Noninferiority was met if the higher 95% confidence interval (CI) for the difference in the incidences of preterm preeclampsia between the 2 groups was <1.9%.
A total of 964 pregnant individuals, who were identified as high-risk for preterm preeclampsia and prescribed 150 mg of aspirin daily at bedtime, were eligible for the analysis. The rates of preterm preeclampsia in the intervention and control groups were 1.48% and 1.73%, respectively (absolute difference, −0.25% 95% CI, −1.86% to 1.36%).
In conclusion, the threshold for noninferiority was not met. In pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio of ≤38, discontinuing aspirin at 24 to 28 weeks' gestation was noninferior to continuing aspirin until 36 weeks to prevent preterm preeclampsia.
To describe the ultrasound findings, maternal and perinatal variables in cases with a prenatal diagnosis of persistence of right umbilical vein.
A descriptive analysis of cases with prenatal ...diagnosis of persistence of right umbilical vein in the Fetal Medicine Unit, Department of Obstetrics and Gynecology, Hospital Universitario Severo Ochoa. We described ultrasound findings, maternal and perinatal variables.
We explored 9198 fetuses and 6 cases (0.06%) were diagnosis prenatally of persistent right umbilical vein, between 20 and 29 weeks of gestation. The male/female ratio was 1/1. Ductus venosus was presented in all cases. Two fetuses (33%) were proved to have other structural anomalies and their parents opted for termination of the pregnancy. All cases had no chromosomal anomaly associated and after birth, neonatal developments were favorable.
Based on our results and a literature review, after prenatal diagnosis of persistent right umbilical vein, an exhaustive morphological study, which included a fetal echocardiography, is mandatory in order to rule out other structural malformations. Indication for fetal karyotype study has to be individualized considering persistence right umbilical vein type and other ultrasound findings.
The aim of this study was to assess the incidence of obstetric and neonatal complications in pregnant women with “normal” thyroid-stimulating hormone (TSH) levels in the first trimester (group A) and ...to compare them with those with “slightly elevated” TSH (SET) levels treated with levothyroxine (group B2) or not treated (group B1).
A total of 2375 women who had been performed laboratory tests in their first trimester of pregnancy were detected at our hospital between April 2015 and August 2017. Of these, 469 patients with SET were prospectively detected and randomized to groups B1 (227) and B2 (242). They were monitored prospectively until 6 months after delivery. Data of the control group (n=1906, group A) were retrospectively reviewed. A total of 1745 women were analyzed. Variables assessed included demographic and clinical characteristics and complications of pregnancy and delivery.
A, B1, and B2 had similar clinical characteristics. There were no statistically significant differences in complications between the three groups during pregnancy, except in that natural deliveries were more common in group A as compared to group B1 (76.8% vs. 68.7%, p 0.017) and group B2 (66.3%), p<0.002). There were more induced deliveries in groups B1 (35.8%), and B2 (36.2%) than in group A (18.4%), p<0.01. Although the recommended TSH level was achieved in the second and third trimesters, no benefit could be found of treatment of SET.
Although there were less natural deliveries and more induced deliveries in patients with SET, treatment with levothyroxine could not reverse this situation, despite achievement of levels considered appropriate in the second and third trimester.
El propósito de este estudio fue investigar la incidencia de complicaciones obstétricas y neonatales en mujeres embarazadas con una tirotropina (TSH) «normal» en el primer trimestre (grupo A) y compararlas con aquellas con una TSH «discretamente elevada» (SET) tratadas con levotiroxina (grupo B2) o no (grupo B1).
Dos mil trescientos setenta y cinco gestantes con analítica en el primer trimestre fueron detectadas en nuestro hospital entre abril de 2015 y agosto de 2017. Cuatrocientos sesenta y nueve pacientes con SET se detectaron prospectivamente y randomizaron a los grupos B1 (227) y B2 (242). Se siguieron prospectivamente hasta 6 meses posparto. Los datos del grupo control (n=1.906, grupo A) se revisaron retrospectivamente. Se analizaron 1.745 pacientes. Las variables incluyeron características demográficas, clínicas y complicaciones de la gestación y el parto.
A, B1 y B2 eran comparables en sus características clínicas. Los partos eutócicos fueron más frecuentes en el grupo A que en el B1 (76,8 vs. 68,7%, p0,017) y B2 (66,3%, p<0,002). Hubo más partos inducidos en los grupos B1 (35,8%) y B2 (36,2%) que en A (18,4%), p<0,01. Aunque se alcanzó el nivel de TSH recomendado en el segundo y tercer trimestres, no pudimos encontrar ningún beneficio en el tratamiento de SET.
Aunque hemos encontrado menos partos eutócicos y más partos inducidos en las gestantes con SET, el tratamiento con levotiroxina no pudo revertirlo, pese a alcanzar un valor considerado apropiado en el segundo y tercer trimestre.
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