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OBJECTIVE: Determine if knowledge of a third-trimester ultrasound diagnosis of large for gestational age (LGA) independently increases the risk of cesarean delivery (CD). STUDY DESIGN: Historical cohort comparing CD rate among patients diagnosed with an LGA fetus on a clinically indicated ultrasound from January 2017 to July 2021 with those without an LGA diagnosis at 34 weeks or later. LGA was defined as an ultrasound-estimated fetal weight greater than or equal to the 90th percentile for the gestational age. Univariate analysis was performed to identify significant confounding variables and was utilized as covariates for binary regression with CD rate as the primary outcome, and adjusted odds ratios (AOR) with 95% confidence intervals (CI) were calculated. Nulliparous term singleton vertex (NTSV) and multiparous CD rates were also compared. RESULTS: There were 447 patients diagnosed with an LGA fetus and 1971 patients without an LGA diagnosis on third-trimester ultrasound. The positive predictive value of LGA diagnosis was 50.1% and the false positive rate was 10.6%. Patients with a diagnosis of LGA had higher AOR of CD (OR 2.11, 95% CI 1.56-2.83), and higher AOR of NTSV CD (OR 1.88, 95% CI 1.14-3.13) compared with those without an LGA diagnosis. There was no difference in the rates of non-medically indicated CD, multiparous primary CD, and attempted and successful TOLAC. CONCLUSION: Our results suggest third-trimester ultrasound diagnosis of LGA independently increases odds of CD, specifically among nulliparous patients, and the potential bias may be one factor contributing to excessive CDs and NTSV CDs.
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OBJECTIVE: To investigate the optimal gestational age to deliver pregnant people with chronic hypertension to improve perinatal outcomes. METHODS: We conducted a planned secondary analysis of a randomized controlled trial of chronic hypertension treatment to different blood pressure goals. Participants with term, singleton gestations were included. Those with fetal anomalies and those with a diagnosis of preeclampsia before 37 weeks of gestation were excluded. The primary maternal composite outcome included death, serious morbidity (heart failure, stroke, encephalopathy, myocardial infarction, pulmonary edema, intensive care unit admission, intubation, renal failure), preeclampsia with severe features, hemorrhage requiring blood transfusion, or abruption. The primary neonatal outcome included fetal or neonatal death, respiratory support beyond oxygen mask, Apgar score less than 3 at 5 minutes, neonatal seizures, or suspected sepsis. Secondary outcomes included intrapartum cesarean birth, length of stay, neonatal intensive care unit admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn, and hypoglycemia. Those with a planned delivery were compared with those expectantly managed at each gestational week. Adjusted odds ratios (aORs) with 95% CIs are reported. RESULTS: We included 1,417 participants with mild chronic hypertension; 305 (21.5%) with a new diagnosis in pregnancy and 1,112 (78.5%) with known preexisting hypertension. Groups differed by body mass index (BMI) and preexisting diabetes. In adjusted models, there was no association between planned delivery and the primary maternal or neonatal composite outcome in any gestational age week compared with expectant management. Planned delivery at 37 weeks of gestation was associated with RDS (7.9% vs 3.0%, aOR 2.70, 95% CI, 1.40-5.22), and planned delivery at 37 and 38 weeks was associated with neonatal hypoglycemia (19.4% vs 10.7%, aOR 1.97, 95% CI, 1.27-3.08 in week 37; 14.4% vs 7.7%, aOR 1.82, 95% CI, 1.06-3.10 in week 38). CONCLUSION: Planned delivery in the early-term period compared with expectant management was not associated with a reduction in adverse maternal outcomes. However, it was associated with increased odds of some neonatal complications. Delivery timing for individuals with mild chronic hypertension should weigh maternal and neonatal outcomes in each gestational week but may be optimized by delivery at 39 weeks.
Subject(s)
Gestational Age , Hypertension , Humans , Female , Pregnancy , Adult , Infant, Newborn , Delivery, Obstetric , Pregnancy Complications, Cardiovascular/therapy , Pregnancy Outcome , Time Factors , Cesarean Section/statistics & numerical data , Chronic Disease , Young AdultABSTRACT
OBJECTIVE: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial. METHODS: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated. RESULTS: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations. CONCLUSION: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.
Subject(s)
Antihypertensive Agents , Hypertension , Pregnancy Complications, Cardiovascular , Humans , Female , Pregnancy , Infant, Newborn , Adult , Antihypertensive Agents/therapeutic use , Hypertension/drug therapy , Pregnancy Outcome , Arterial Pressure , Hypertension, Pregnancy-Induced/drug therapyABSTRACT
PURPOSE: The hypothesis was fetal sex determination by ultrasound at 11-14 weeks' gestation has sufficient accuracy to be clinically relevant. METHODS: Fetal sex assessment by transabdominal ultrasound was performed in 567 fetuses at 11-14 weeks' gestation (CRL: 45-84 mm). A mid-sagittal view of the genital region was obtained. The angle of the genital tubercle to a horizontal line through the lumbosacral skin surface was measured. The fetus was assigned male sex if the angle was > 30°, and female sex if the genital tubercle was parallel or convergent (< 10°). At an intermediate angle of 10-30°, the sex was not assigned. The results were divided into three categories based on gestational age: 11 + 2 to 12 + 1, 12 + 2 to 13 + 1, and 13 + 2 to 14 + 1 weeks' gestation. To establish its accuracy, the first trimester fetal sex determination was compared to fetal sex determined on a mid-second trimester ultrasound. RESULTS: Sex assignment was successful in 534/683 (78%) of the cases. The overall accuracy of fetal sex assignment across all gestational ages studied was 94.4%. It was 88.3%, 94.7%, and 98.6% at 11 + 2 to 12 + 1, 12 + 2 to 13 + 1, and 13 + 2 to 14 + 1 weeks' gestation, respectively. CONCLUSION: Prenatal sex assignment at the time of first trimester ultrasound screening has a high accuracy rate. The accuracy improved with increasing gestational age, which suggests that if clinically important decisions, such as chorionic villus sampling, are to be made based on fetal sex, they should be delayed until the latter part of the first trimester.
Subject(s)
Prenatal Care , Ultrasonography, Prenatal , Pregnancy , Humans , Male , Female , Pregnancy Trimester, First , Ultrasonography, Prenatal/methods , Ultrasonography , Gestational AgeABSTRACT
INTRODUCTION: The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21-0.40) FiO2 and its potential effect modifiers. METHODS AND ANALYSIS: Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60-1.00) to regular FiO2 (0.21-0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>2.5 hour). ETHICS AND DISSEMINATION: Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42018090261.
Subject(s)
Oxygen , Surgical Wound Infection , Adult , Humans , Surgical Wound Infection/prevention & control , Systematic Reviews as Topic , Meta-Analysis as Topic , Respiration, Artificial , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: Fetal electrocardiogram (ECG) ST changes are associated with fetal cardiac hypoxia. Our objective was to evaluate ST changes by maternal diabetic status and stage of labor. METHODS: This was a secondary analysis of a multicentered randomized-controlled trial in which laboring patients with singleton gestations underwent fetal ECG scalp electrode placement and were randomly assigned to masked or unmasked ST-segment readings. Our primary outcome was the frequency of fetal ECG tracings with ST changes by the stage of labor. ECG tracings were categorized into mutually exclusive groups (ST depression, ST elevation without ST depression, or no ST changes). We compared participants with DM, gestational diabetes mellitus (GDM), and no DM. RESULTS: Of the 5,436 eligible individuals in the first stage of labor (95 with pregestational DM and 370 with GDM), 4,427 progressed to the second stage. ST depression occurred more frequently in the first stage of labor in participants with pregestational DM (15%, adjusted odds ratio [aOR] 2.20, 95% confidence interval [CI] 1.14-4.24) and with GDM (9.5%, aOR 1.51, 95% CI 1.02-2.25) as compared with participants without DM (5.7%). The frequency of ST elevation was similar in participants with pregestational DM (33%, aOR 0.79, 95% CI 0.48-1.30) and GDM (33.2%, aOR 0.91, 95% CI 0.71-1.17) as compared with those without DM (34.2%). In the second stage, ST depression did not occur in participants with pregestational DM (0%) and occurred more frequently in participants with GDM (3.5%, aOR 2.01, 95% CI 1.02-3.98) as compared with those without DM (2.0%). ST elevation occurred more frequently in participants with pregestational DM (30%, aOR 1.81, 95% CI 1.02-3.22) but not with GDM (19.0%, aOR 1.06, 95% CI 0.77-1.47) as compared with those without DM (17.8%). CONCLUSION: ST changes in fetal ECG occur more frequently in fetuses of diabetic mothers during labor. CLINICALTRIALS: gov number, NCT01131260. PRECIS: ST changes in fetal ECG, a marker of fetal cardiac hypoxia, occur more frequently in fetuses of diabetic parturients. KEY POINTS: · Fetal hypertrophic cardiomyopathy (HCM) and cardiac dysfunction occur frequently among fetuses of diabetic patients.. · Fetal ECG changes such as ST elevation and depression reflect cardiac hypoxia.. · Fetuses of diabetic patients demonstrate a higher prevalence of fetal ECG tracings with ST changes..
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OBJECTIVE: This study aimed to evaluate whether intrapartum fetal electrocardiogram (ECG) tracings with ST-elevation or depression occur more frequently in each stage of labor in small-for-gestational age (SGA) or large-for-gestational age (LGA), as compared with appropriate-for-gestational age (AGA) fetuses. STUDY DESIGN: We conducted a secondary analysis of a large, multicenter trial in which laboring patients underwent fetal ECG waveform-analysis. We excluded participants with diabetes mellitus and major fetal anomalies. Birth weight was categorized as SGA (<10th percentile), LGA (>90th percentile), or AGA (10-90th percentile) by using a gender and race/ethnicity specific nomogram. In adjusted analyses, the frequency of ECG tracings with ST-depression or ST-elevation without depression was compared according to birthweight categories and labor stage. RESULTS: Our study included 4,971 laboring patients in the first stage and 4,074 in the second stage. During the first stage of labor, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (6.7 vs. 5.5%; adjusted odds ratio [aOR]: 1.41, 95% confidence interval [CI]: 0.93-2.13), or in ST-elevation without depression (35.8 vs. 34.1%; aOR: 1.17, 95% CI: 0.94-1.46). During the second stage, there were no differences in the frequency of ST-depression in SGA fetuses compared with AGA fetuses (1.6 vs. 2.0%; aOR: 0.69, 95% CI: 0.27-1.73), or in ST-elevation without depression (16.2 vs. 18.1%; aOR: 0.90, 95% CI: 0.67-1.22). During the first stage of labor, there were no differences in the frequency of ST-depression in LGA fetuses compared with AGA fetuses (6.3 vs. 5.5%; aOR: 0.97, 95% CI: 0.60-1.57), or in ST-elevation without depression (33.1 vs. 34.1%; aOR: 0.80, 95% CI: 0.62-1.03); during the second stage of labor, the frequency of ST-depression in LGA compared with AGA fetuses (2.5 vs. 2.0%, aOR: 1.36, 95% CI: 0.61-3.03), and in ST-elevation without depression (15.5 vs. 18.1%; aOR: 0.83, 95% CI: 0.58-1.18) were similar as well. CONCLUSION: The frequency of intrapartum fetal ECG tracings with ST-events is similar among SGA, AGA, and LGA fetuses. KEY POINTS: · SGA and LGA neonates are at increased risk of cardiac dysfunction.. · Fetal ECG has been used to evaluate fetal response to hypoxia.. · Fetal ST-elevation and ST-depression occur during hypoxia.. · Frequency of intrapartum ST-events is similar among SGA, AGA and LGA fetuses..
Subject(s)
Electrocardiography , Fetal Macrosomia/physiopathology , Infant, Small for Gestational Age/physiology , Prenatal Diagnosis , Female , Fetus , Humans , Labor Stage, First , Labor Stage, Second , PregnancyABSTRACT
OBJECTIVE: To evaluate intrapartum resuscitation interventions and improvement in category II fetal heart rate (FHR) tracings. METHODS: This secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis included all participants with category II FHR tracings undergoing intrauterine resuscitation: maternal oxygen, intravenous fluid bolus, amnioinfusion, or tocolytic administration. Fetal heart rate pattern-recognition software was used to confirm category II FHR tracings 30 minutes before intervention and to analyze the subsequent 60 minutes. The primary outcome was improvement to category I within 60 minutes. Secondary outcomes included FHR tracing improvement to category I 30-60 minutes after the intervention and composite neonatal outcome. RESULTS: Of 11,108 randomized participants, 2,251 (20.3%) had at least one qualifying intervention for category II FHR tracings: 63.7% improved to category I within 60 minutes and 50.5% improved at 30-60 minutes. Only 3.4% underwent cesarean delivery and 4.1% an operative vaginal delivery for nonreassuring fetal status within 60 minutes after the intervention. Oxygen administration was the most common intervention (75.4%). Among American College of Obstetricians and Gynecologists-defined subgroups that received oxygen, the absent FHR accelerations and absent-minimal FHR variability subgroup (n=332) was more likely to convert to category I within 60 minutes than the FHR accelerations or "moderate FHR variability" subgroup (n=1,919) (77.0% vs 63.0%, odds ratio [OR] 2.0, 95% CI 1.4-2.7). The incidence of composite neonatal adverse outcome for category II tracings was 2.9% (95% CI 2.2-3.7%) overall; 2.8% (95% CI 2.0-3.8%) for improvement to category I within 60 minutes (n=1,433); and 3.2% (95% CI 2.1-4.6%) for no improvement within 60 minutes (n=818). However, the group with improvement had 29% lower odds for higher level neonatal care (11.8% vs 15.9%, OR 0.71, 95% CI 0.55-0.91). CONCLUSION: Nearly two thirds of category II FHR tracings improved to category I within 60 minutes of intervention with a relatively low overall rate of the composite neonatal adverse outcome. FUNDING SOURCE: Funded in part by Neoventa Medical.
Subject(s)
Fetal Distress/therapy , Heart Rate, Fetal , Prenatal Care , Resuscitation , Adult , Cardiotocography , Cesarean Section , Delivery, Obstetric , Female , Fetal Distress/ethnology , Humans , Pregnancy , Pregnancy Outcome , Randomized Controlled Trials as TopicABSTRACT
Proteoglycans have a core polypeptide connected to glycosaminoglycans (GAGs) via a common tetrasaccharide linker region. Defects in enzymes that synthesize the linker result in a group of autosomal recessive conditions called "linkeropathies". Disease manifests with skeletal and connective tissue features, including short stature, hyperextensible skin, and joint hypermobility. We report a family with three affected pregnancies showing short limbs, cystic hygroma, and perinatal death. Two spontaneously aborted; one survived 1 day after term delivery, and had short limbs, bell-shaped thorax, 11 ribs, absent thumbs, and cleft palate. Exome sequencing of the proband and one affected fetus identified compound heterozygous missense variants, NM_007255.3: c.808C>T (p.(Arg270Cys)) and NM_007255.3: c.398A>G (p.(Gln133Arg)), in B4GALT7, a gene required for GAG linker biosynthesis. Homozygosity for p.(Arg270Cys), associated with partial loss of B4GALT7 function, causes Larsen of Reunion Island syndrome (LRS), however no previous studies have linked p.(Gln133Arg) to disease. The p.(Gln133Arg) and p.(Arg270Cys) variants were transfected into CHO pgsB-618 cells. High protein expression of p.(Gln133Arg) was found, with mislocalization, compared to p.(Arg270Cys) that had a normal Golgi-like pattern. The p.(Gln133Arg) had almost no enzyme activity and little production of heparan sulfate GAGs, while p.(Arg270Cys) only had 17% of wild-type activity. These findings expand the phenotype of B4GALT7-related linkeropathies to include lethal skeletal dysplasia due to more severe loss of function.
Subject(s)
Galactosyltransferases/genetics , Musculoskeletal Abnormalities/diagnosis , Musculoskeletal Abnormalities/genetics , Mutation , Phenotype , Abortion, Spontaneous , Cell Line , Connective Tissue Diseases/diagnosis , Connective Tissue Diseases/genetics , Enzyme Activation , Female , Galactosyltransferases/metabolism , Genetic Association Studies , Humans , Mutagenesis, Site-Directed , Pregnancy , Radiography , Syndrome , Exome SequencingABSTRACT
OBJECTIVE: To compare fetal heart rate (FHR) patterns during the last hour of labor between small-for-gestational-age (SGA; birth weight less than the 10th percentile for gestational age) and appropriate-for-gestational-age (AGA; birth weight at the 10-90th percentile) neonates at 36 weeks of gestation or greater. We also compared the rate of cesarean delivery and composite neonatal morbidity among SGA and AGA newborns. METHODS: This is a secondary analysis of a randomized trial of intrapartum fetal electrocardiographic ST-segment analysis. We excluded women with chorioamnionitis, insufficient duration of FHR tracing in the hour before delivery, and anomalous newborns. Fetal heart rate patterns were categorized by computerized pattern recognition software (PeriCALM Patterns). Composite neonatal morbidity was defined as any of the following: intrapartum fetal death, Apgar score 3 or less at 5 minutes, cord artery pH 7.05 or less, base deficit 12 mmol/L or greater, neonatal seizure, intubation at delivery, neonatal encephalopathy, and neonatal death. Logistic regression was used to evaluate the association between FHR patterns and SGA adjusted for magnesium sulfate exposure and stage of labor. RESULTS: Of the 11,108 women randomized, 85% (n=9,402) met inclusion criteria, of whom 9% were SGA. In the last hour, the likelihood of accelerations was significantly lower among SGA than AGA neonates (72.4% vs 66.8%; P=.001). Variable decelerations lasting greater than 60 seconds, with depth greater than 60 beats per minute (bpm) or nadir less than 60 bpm, were significantly more common with SGA than AGA (all P<.001). The rate of late decelerations, prolonged decelerations, or bradycardia were similar between SGA and AGA (all P>.05). Cesarean delivery for fetal indications was significantly more common with SGA (7.0%) than AGA (4.0%; P<.001). The composite neonatal morbidity was 1.4% among SGA and 1.0% among AGA (odds ratio 1.40, 95% CI 0.74-2.64). CONCLUSION: Although the FHR patterns in the last hour of labor differ among SGA and AGA neonates, as does the rate of cesarean delivery, the composite neonatal morbidity was similar.
Subject(s)
Heart Rate, Fetal , Infant, Small for Gestational Age/physiology , Labor Stage, Second , Adolescent , Adult , Female , Humans , Infant, Newborn , Pregnancy , Young AdultABSTRACT
OBJECTIVE: To promote use of progestogen therapy to reduce premature births in Ohio by 10%. METHODS: The Ohio Perinatal Quality Collaborative initiated a quality improvement project in 2014 working with clinics at 20 large maternity hospitals, Ohio Medicaid, Medicaid insurers, and service agencies to use quality improvement methods to identify eligible women and remove treatment barriers. The number of women eligible for prophylaxis, the percent prescribed a progestogen before 20 and 24 weeks of gestation, and barriers encountered were reported monthly. Clinics were asked to adopt protocols to identify candidates and initiate treatment promptly. System-level changes were made to expand Medicaid eligibility, maintain Medicaid coverage during pregnancy, improve communication, and adopt uniform data collection and efficient treatment protocols. Rates of singleton births before 32 and 37 weeks of gestation in Ohio hospitals were primary outcomes. We used statistical process control methods to analyze change and generalized linear mixed models to estimate program effects accounting for known risk factors. RESULTS: Participating sites tracked 2,562 women eligible for treatment between January 1, 2014, and November 30, 2015. Late entry to care, variable interpretation of treatment guidelines, maintenance of Medicaid coverage, and inefficient communication among health care providers and insurers were identified as treatment barriers. Births before 32 weeks of gestation decreased in all hospitals by 6.6% and in participating hospitals by 8.0%. Births before 32 weeks of gestation to women with prior preterm birth decreased by 20.5% in all hospitals, by 20.3% in African American women, and by 17.1% in women on Medicaid. Births before 37 weeks of gestation were minimally affected. Adjusting for risk factors and birth clustering by hospital confirmed a program-associated 13% (95% confidence interval 0.3-24%) reduction in births before 32 weeks of gestation to women with prior preterm birth. CONCLUSION: The Ohio progestogen project was associated with a sustained reduction in singleton births before 32 weeks of gestation in Ohio.
Subject(s)
Health Promotion/statistics & numerical data , Hospitals, Maternity/statistics & numerical data , Premature Birth/prevention & control , Progestins/therapeutic use , Adult , Black or African American/statistics & numerical data , Female , Gestational Age , Health Promotion/methods , Humans , Medicaid/statistics & numerical data , Ohio/epidemiology , Pregnancy , Premature Birth/epidemiology , Program Evaluation , United StatesABSTRACT
BACKGROUND: Infants who are born at 34 to 36 weeks of gestation (late preterm) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases the risks of neonatal morbidities. METHODS: We conducted a multicenter, randomized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who were at high risk for delivery during the late preterm period (up to 36 weeks 6 days). The participants were assigned to receive two injections of betamethasone or matching placebo 24 hours apart. The primary outcome was a neonatal composite of treatment in the first 72 hours (the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours, extracorporeal membrane oxygenation, or mechanical ventilation) or stillbirth or neonatal death within 72 hours after delivery. RESULTS: The primary outcome occurred in 165 of 1427 infants (11.6%) in the betamethasone group and 202 of 1400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval [CI], 0.66 to 0.97; P=0.02). Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis. Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group (24.0% vs. 15.0%; relative risk, 1.60; 95% CI, 1.37 to 1.87; P<0.001). CONCLUSIONS: Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications. (Funded by the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01222247.).
Subject(s)
Betamethasone/administration & dosage , Glucocorticoids/administration & dosage , Infant, Premature, Diseases/prevention & control , Respiratory Tract Diseases/prevention & control , Adult , Betamethasone/adverse effects , Bronchopulmonary Dysplasia/epidemiology , Bronchopulmonary Dysplasia/prevention & control , Female , Fetal Membranes, Premature Rupture , Gestational Age , Glucocorticoids/adverse effects , Humans , Hypoglycemia/chemically induced , Infant, Newborn , Infant, Premature , Infant, Premature, Diseases/chemically induced , Infant, Premature, Diseases/mortality , Injections, Intramuscular/adverse effects , Obstetric Labor, Premature , Oxygen Inhalation Therapy , Pregnancy , Pregnancy Trimester, Third , Pulmonary Surfactants/therapeutic use , Respiration, Artificial/statistics & numerical dataABSTRACT
BACKGROUND: Twin pregnancies are associated with an increased risk of perinatal morbidity and mortality primarily due to spontaneous preterm deliveries. The mean gestational age for delivery is 35.3 weeks and twins account for 23% of preterm births <32 weeks. A number of strategies have been proposed to prevent preterm deliveries: tocolytics, bed rest, hospitalization, home uterine activity monitoring, cerclage, and most recently, progesterone. Unfortunately, none have proven effective. Recent metaanalyses and reviews suggest that transvaginal cervical length (TVCL) ultrasound in the second trimester is a powerful predictor of preterm birth among asymptomatic women. Indeed, TVCL has the highest positive and negative predictive values for determining the risk of spontaneous preterm delivery in twin pregnancies. It follows that TVCL assessment may allow identification of a subset of twin pregnancies that re better candidates for interventions intended to prevent prematurity. OBJECTIVE: We sought to determine whether use of TVCL prolongs gestation in twin pregnancies. STUDY DESIGN: This is a multicenter, randomized, controlled trial of 125 dichorionic or monochorionic/diamniotic twin pregnancies without prior preterm birth <28 weeks. The study group (n = 63) had TVCL and digital exams monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage. The control group (n = 62) had monthly digital cervical examinations but no routine TVCL ultrasound examinations. The primary outcome was gestational age at delivery. Secondary outcomes included percentage of deliveries <35 weeks, and maternal and neonatal outcomes. RESULTS: The mean gestational age at delivery was 35.7 weeks (95% confidence interval [CI], 35.2-36.2) among those managed with TVCL and 35.5 weeks (95% CI, 34.7-36.4) among the control patients. The Kaplan-Meier estimates of deliveries <38 weeks were not significantly different between groups. This was true whether we compared curves with a log-rank test (P = .67), Breslow test (P = .67), or Tarone-Ware test (P = .64). The percentage of deliveries <35 0/7 weeks did not differ: 27.4% for subjects managed with routine TVCL and 28.6% for control subjects (relative risk, 0.96; 95% CI, 0.60-1.54). Our study had an 80% power to detect a 12-day difference in the gestational age at delivery with 95% confidence. CONCLUSION: The overall mean length of gestation and the percentage of women delivering <35 weeks did not differ between twin gestations managed with TVCL and digital exams monthly from 16-28 weeks with a standard algorithm for activity restriction and cerclage and controls who had monthly digital cervical examinations but no routine TVCL. Routine second-trimester transvaginal ultrasound assessment of cervical length is not associated with improved outcomes when incorporated into the standard management of otherwise low-risk twin pregnancies.
Subject(s)
Bed Rest/methods , Cerclage, Cervical/methods , Cervix Uteri/diagnostic imaging , Pregnancy, Twin , Premature Birth/prevention & control , Adult , Cervical Length Measurement , Delivery, Obstetric , Female , Humans , Kaplan-Meier Estimate , Pregnancy , Risk Assessment , Young AdultABSTRACT
OBJECTIVE: To analyze the amount of surfactant protein (SP)-B and lecithin/sphingomyelin (L/S) ratio in response to betamethasone (BMS) alone as compared with magnesium sulfate (Mg(2+)), indomethacin (Indo), and nifedipine (Nif) with or without BMS. STUDY DESIGN: NCI-H441 human lung cells were grown and distributed into eight plates. BMS and tocolytics were added and the final plates were: control, BMS only, and each tocolytic ± BMS. Cells were stained with SP-B antibodies and relative fluorescence was measured. Lipids were also extracted, identified, and examined for relative densities. The L/S ratio was calculated. RESULTS: Nine independent measurements were obtained for each plate. The protein analysis revealed that among all eight plates, SP-B levels were highest among BMS only. There was a nonsignificant decrease in SP-B in each of the combinations of tocolytics + BMS as compared with BMS only. Compared with BMS only, L/S ratio was decreased in Mg(2+) + BMS (p = 0.041), Indo + BMS (p = 0.042), and Nif + BMS (p = 0.025). CONCLUSION: In our in vitro human lung cell model, SP-B and L/S ratio increased in response to BMS administration alone. The addition of tocolytics to BMS resulted in no increase in L/S ratio and no changes seen in SP-B production compared with BMS alone.
Subject(s)
Betamethasone/pharmacology , Glucocorticoids/pharmacology , Lecithins/metabolism , Pulmonary Surfactant-Associated Protein B/drug effects , Sphingomyelins/metabolism , Tocolytic Agents/pharmacology , Cell Line , Humans , Indomethacin/pharmacology , Lung/cytology , Magnesium Sulfate/pharmacology , Nifedipine/pharmacology , Pulmonary Surfactant-Associated Protein B/metabolismABSTRACT
BACKGROUND: It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes. METHODS: We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy. RESULTS: A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups. CONCLUSIONS: Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).
Subject(s)
Cardiotocography/methods , Electrocardiography , Adult , Apgar Score , Cesarean Section/statistics & numerical data , Female , Fetal Death/prevention & control , Heart Rate, Fetal , Humans , Infant , Infant Mortality , Infant, Newborn , Labor, Obstetric , PregnancyABSTRACT
Objective. To determine if there was an increase in postpartum (PP) hemorrhage after decreasing the PP oxytocin dose from 40 to 30 units. Study Design. Retrospective cohort study comparing 8 months before to 8 months after the change. PP day 1 hemoglobin was subtracted from admission hemoglobin. Mean change was compared by Student's t-test. The best fit polynomial was analyzed for trends between the two time frames. Women who received blood transfusions were excluded. Results. 73/3564 (2.0%) women received blood transfusions in the pre group and 64/3295 (1.9%) women in the post group, P = 0.8. Mean hemoglobin change ± standard deviation was 1.53 ± 0.03 g/dL for pre versus 1.52 ± 0.05 g/dL for post, P = 0.68. 1003/3114 (32.2%) in the pre group had a hemoglobin decrease of ≥2 g/dL compared to 918/2895 (31.7%) in the post group, P = 0.7. 261/3114 (8.4%) in the pre group had a hemoglobin decrease of ≥3 g/dL compared to 252/2895 (8.7%), P = 0.7. There were no significant trends between the two time frames. Conclusion. The change in the dose of PP oxytocin did not result in an increase in postpartum hemorrhage or an increase in the need for blood transfusion.
Subject(s)
Clinical Protocols/standards , Oxytocics/administration & dosage , Oxytocin/administration & dosage , Postpartum Hemorrhage/prevention & control , Adult , Blood Transfusion/statistics & numerical data , Cohort Studies , Female , Hemoglobins/analysis , Humans , Patient Safety , Postpartum Hemorrhage/blood , Postpartum Hemorrhage/therapy , Pregnancy , Retrospective Studies , Treatment OutcomeABSTRACT
A myriad of factors have been linked to increased risk for intrauterine growth restriction and the associated complications; the majority of which are based on observational statistics of demographics, socioeconomics and patient history. Unfortunately, there is a paucity of factors available that can appropriately address the underlying anatomy and physiology responsible for intrauterine growth restriction. To this point, it becomes necessary to use data acquisition modalities capable of addressing both the etiology and pathology in an effort to improve clinical management strategies. Near-infrared spectroscopy, although not traditionally used in standard, clinical screening has proven valuable for risk assessment in a number of recent investigational studies. Simulations based on the current literature are presented to assess near infrared spectroscopy utility regarding the ability to distinguish between the normal fetus and the growth restricted fetus. Findings are presented for all simulated data as well as the equipment-specific data derived from the NIRO-100 system (Hamamatsu Photonics, Hamamatsu, Japan). Results suggest an overall sensitivity and specificity on the order of 62% and 58%, respectively, and NIRO-100 sensitivity and specificity on the order of 85% and 92%, respectively.
Subject(s)
Fetal Growth Retardation/diagnosis , Spectroscopy, Near-Infrared , Female , Fetal Growth Retardation/metabolism , Gestational Age , Humans , Oxygen Consumption , Placenta/metabolism , Pregnancy , Reproducibility of Results , Sensitivity and Specificity , Spectroscopy, Near-Infrared/instrumentation , Spectroscopy, Near-Infrared/methodsABSTRACT
BACKGROUND: Brodifacoum, a superwarfarin, is a common household agent used for rodenticides. We present a case of maternal brodifacoum ingestion that resulted in neonatal death. CASE: A 19-year-old primigravid woman presented at 32 weeks of gestation with spontaneous mucosal bleeding. Her fetus showed evidence of acidosis on external fetal monitoring. Laboratory values were consistent with maternal coagulopathy. After correction of the coagulopathy, the patient was taken for urgent cesarean delivery. The neonate showed evidence of fetal coagulopathy and died at 4 days of life. CONCLUSION: Brodifacoum is a dangerous household chemical that, if ingested, can result in significant morbidity and mortality for both mother and neonate. Increased awareness of the serious and potentially lethal effects of brodifacoum is important.
Subject(s)
4-Hydroxycoumarins/poisoning , Anticoagulants/poisoning , Blood Coagulation Disorders/chemically induced , Infant, Newborn, Diseases/chemically induced , Prenatal Exposure Delayed Effects , Adult , Fatal Outcome , Female , Humans , Infant, Newborn , Maternal-Fetal Exchange , Pregnancy , Rodenticides/poisoning , Young AdultABSTRACT
OBJECTIVE: To determine if supplemental perioperative oxygen will reduce surgical site infection (SSI) following cesarean delivery. METHODS: This is a randomized, controlled trial evaluating SSI following either 30% or 80% fraction of inspired oxygen (FIO2) during and 2 hours after cesarean delivery. Anesthesia providers administered FIO2 via a high-flow oxygen blender. Subjects, surgeons, and wound evaluation teams were blinded. Serial wound evaluations were performed. Data were analyzed using logistic regression models, Fisher exact test, and t test. RESULTS: In all, 179 women were randomized, and 160 subjects were included in the analysis. There were 12/83 (14.5%) SSIs in the control group versus 10/77 (13.0%) in the investigational group (p = 0.82). Caucasian race, increased body mass index, and longer operative time were identified as significant risk factors for infection (p = 0.026, odds ratio 0.283; p = 0.05, odds ratio = 1.058; p = 0.037, odds ratio = 1.038, respectively). CONCLUSION: Perioperative oxygenation with 80% Fio2 is not effective in reducing SSI following cesarean delivery.
Subject(s)
Cesarean Section/adverse effects , Oxygen Inhalation Therapy , Oxygen/administration & dosage , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & control , Adult , Body Mass Index , Double-Blind Method , Female , Humans , Operative Time , Postoperative Care , Pregnancy , White People , Young AdultABSTRACT
We sought to evaluate the effectiveness of daily oral micronized progesterone (MP) in preventing recurrent spontaneous preterm birth (RSPB) and whether MP increases maternal serum progesterone. We performed a pilot, single-center, randomized, double-blind, placebo-controlled trial in women with a prior preterm birth and current singleton gestation at 16 to 20 weeks ( N = 33). The primary outcome was the rate of RSPB. Subjects were given either daily MP (400 mg) or placebo from 16 to 34 weeks. Serum progesterone was obtained at enrollment and in the late second/early third trimester. Pregnancy outcome data were collected. RSPB occurred in 5/19 (26.3%) in the MP group versus 8/14 (57.1%) in placebo group ( P = 0.15). The mean age at delivery was 37.0 ± 2.7 weeks for the MP group versus 35.9 ± 2.6 weeks for the placebo ( P = 0.3). Mean serum progesterone at 28 weeks was 122.6 ± 61.8 pg/mL for MP group versus 90.1 ± 38.7 pg/mL for placebo ( P = 0.19). MP was associated with a trend toward a reduction in RSPB and an increase in the maternal serum progesterone. Although the primary outcome in this pilot study did not reach statistical significance, the results suggest a favorable trend meriting further investigation.