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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 evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSION: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.
Subject(s)
Antihypertensive Agents , Hypertension , Labetalol , Nifedipine , Pregnancy Outcome , Humans , Pregnancy , Female , Labetalol/administration & dosage , Labetalol/adverse effects , Labetalol/therapeutic use , Nifedipine/administration & dosage , Nifedipine/adverse effects , Nifedipine/therapeutic use , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/adverse effects , Antihypertensive Agents/therapeutic use , Adult , Hypertension/drug therapy , Infant, Newborn , Pregnancy Complications, Cardiovascular/drug therapy , Hypertension, Pregnancy-Induced/drug therapy , Administration, Oral , Infant, Small for Gestational Age , Pre-Eclampsia/drug therapy , Chronic DiseaseABSTRACT
OBJECTIVE: Nationwide, obstetric clinics modified prenatal care to include telehealth visits in response to the coronavirus disease 2019 (COVID-19) pandemic, enabling the opportunity to investigate its impact on patient outcomes. We hypothesized that use of prenatal telehealth visits would increase the number of prenatal visits, decrease the frequency of urgent triage/emergency department (ED) visits, and improve perinatal outcomes. This study aimed to determine the impact of telehealth on number of obstetric prenatal visits and urgent triage/ED visits amidst the COVID-19 pandemic. STUDY DESIGN: This is a retrospective cohort of patients from a federally qualified health center in central Texas. Patients with a singleton gestation who delivered after 32 weeks were included. Comparison groups were made between those patients who delivered between May 2020 and December 2020 (presumed modified prenatal visit schedule with in-person and telehealth) and those patients delivering between June 2019 and February 2020 (the traditional care model with in-person visits only). Multivariable linear and logistic regression models were used to estimate differences in the number of prenatal visits and unscheduled triage/ED visits. RESULTS: A total of 1,654 patients were identified with 801 (48.4%) patients undergoing modified prenatal care and 853 (51.6%) patients receiving traditional care during the study period. No significant differences were seen in overall prenatal attendance or triage/ED presentations. However, when stratified by parity, multiparous patients undergoing modified prenatal care were less likely to experience an urgent triage/ED presentation (8.7 vs. 12.7%; odds ratio, 1.69; 95% confidence interval, 1.10-2.61). CONCLUSION: When compared with a traditional prenatal visitation cohort prepandemic, patients who received modified telehealth prenatal care during the COVID-19 pandemic had similar prenatal attendance and unscheduled emergency presentations. However, multiparous patients experienced a decreased rate of unscheduled emergency presentations. Supplementing prenatal care with telehealth may provide overall comparable prenatal care delivery. KEY POINTS: · Use of telehealth has the potential to improve prenatal care.. · The COVID-19 pandemic allowed for comparison to traditional prenatal care.. · Multiparous patients had a decreased frequency of ED visits.. · Similar prenatal attendance was seen between both prenatal models..
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OBJECTIVE: Periviable premature rupture of membranes (PROM) counseling should describe maternal and neonatal outcomes associated with both immediate delivery and expectant management. Unfortunately, most published data focuses on neonatal outcomes and maternal risk estimates vary widely. We performed a meta-analysis to describe outcomes associated with expectant management compared with immediate delivery of periviable PROM. STUDY DESIGN: We performed a search on PubMed, MEDLINE, Web of Science, PROSPERO, Cochrane library, and ClinicalTrials.gov utilizing a combination of key terms. Published clinical trials and observational cohorts were included if published after 2000. Publications were selected if they included maternal and/or neonatal outcomes for both expectant management and immediate delivery. Gestational age range was limited from 14 to 25 weeks. The primary outcome was maternal sepsis. Secondary outcomes included chorioamnionitis, hemorrhage, laparotomy, and neonatal survival. Pooled risk differences (RDs) were calculated for each outcome using a random-effects model. Publication bias was assessed using funnel plots and Harbord test. RESULTS: A total of 2,550 studies were screened. After removal of duplicates and filtering by abstract, 44 manuscripts were reviewed. A total of five publications met inclusion for analysis: four retrospective and one prospective. Overall, 364 (68.0%) women underwent expectant management and 171 (32.0%) underwent immediate delivery. Maternal sepsis was significantly more frequent in the expectant group (RD, 4%; 95% confidence interval, 2-7%) as was chorioamnionitis (RD: 30%; p < 0.01) and any laparotomy (RD: 28%; p < 0.01). Neonatal survival in the expectant group was 39% compared with 0% in the immediate group (p < 0.01). CONCLUSION: Women who undergo expectant management following periviable rupture of membranes experience significantly increased risks of sepsis, chorioamnionitis, and laparotomy. Overall, 39% of neonates survive to discharge. Knowledge of these risks is critical to counseling patients with this diagnosis. KEY POINTS: · Expectant management associated with 4% increased risk of sepsis.. · Expectant management associated with 30% increased risk of chorioamnionitis.. · A total of 39% of neonates survived to discharge with expectant management..
Subject(s)
Chorioamnionitis , Fetal Membranes, Premature Rupture , Humans , Pregnancy , Female , Infant, Newborn , Chorioamnionitis/epidemiology , Gestational Age , Watchful Waiting , Sepsis/epidemiology , Delivery, Obstetric , Risk FactorsABSTRACT
OBJECTIVE: Following the release of A Randomized Trial of Induction versus Expectant Management (ARRIVE) trial, the induction of labor at 39 weeks has increased in the United States. The risk of uterine rupture and optimal timing of elective induction in those patients with a prior cesarean delivery is not well-described, and they were not included in the original trial. We aimed to determine the risk of uterine rupture in those patients undergoing elective induction of labor with prior cesarean delivery. STUDY DESIGN: This was a retrospective cohort of participants with prior cesarean delivery from 1996 to 2000. Participants were included if they had two or more prior cesareans. Participants were excluded if they had a history of an unknown prior incision, a classical incision, gestational age <39 weeks, any diabetes, chronic hypertension, twin gestation, collagen or vascular disease, or HIV. Those undergoing expectant management were compared with those undergoing elective induction with no medical or obstetrical indications for delivery. Analysis was performed at three gestational age groups: 39 weeks, 40 weeks, and 41 weeks. The primary outcomes were uterine rupture, rates of successful vaginal delivery, and a composite major morbidity risk. Multivariable logistic regression was performed. RESULTS: At 39 weeks, 618 (10.3%) elective inductions were compared with 5,365 (89.7%) undergoing expectant management; uterine rupture occurred more frequently (13 patients [2.1%] vs. 49 patients [0.9%]; adjusted odds ratio [aOR], 2.5; 95% confidence interval, 1.3-4.6) with fewer successful vaginal birth after cesarean [VBAC; 66.8 vs. 75%; aOR, 0.6; 95% confidence interval, 0.5-0.7]. The risk of uterine rupture was similar between groups at 40 weeks (5 patients [0.8%] vs. 21 patients [1.2%]; p = 0.387) and 41 weeks (7 patients [1.4%] vs. 2 patients (0.8%); p = 0.448). CONCLUSION: Patients undergoing elective induction of labor with a prior cesarean scar had an increased risk of uterine rupture when compared with expectant management at 39 weeks, with fewer successful VBAC. KEY POINTS: · TOLAC elective induction at 39 weeks has an increased risk of uterine rupture.. · TOLAC elective induction at 39 weeks has a less successful chance of vaginal delivery.. · Awaiting spontaneous labor in this cohort does not increase the risk of uterine rupture..
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OBJECTIVES: To assess physiologic blood pressure (BP) changes throughout pregnancy in patients with mild chronic hypertension (CHTN) who do and do not develop preeclampsia (PEC), compared to patients with normal BP. STUDY DESIGN: Retrospective cohort of singleton gestations with CHTN at a single tertiary center from 2000 to 2014 and a randomly selected cohort of patients without CHTN and normal pregnancy outcomes (NML) in the same time period with BP measurements available <12 weeks gestational age. MAIN OUTCOME MEASURES: The primary outcome was gestational age (GA) at nadir of systolic and diastolic BP. Secondary outcomes included perinatal death, umbilical cord pH, maternal and neonatal length of stay, GA at delivery, and mode of delivery. Quadratic mixed models were used to estimate SBP and DBP throughout gestation. RESULTS: Of 367 pregnancies with CHTN, 268 (73%) had CHTN without PEC and 99 (27%) had CHTN with PEC; 198 NML pregnancies were used as a comparison group. The median GA nadir for patients in the NML, CHTN without PEC, and CHTN with PEC for SBP were 20, 24, and 21, respectively. For DBP, the median GA nadir were 22, 24, and 21 for patients in the NML, CHTN without PEC, and CHTN with PEC cohorts, respectively. Adverse secondary outcomes were more frequent in patients with CHTN who developed PEC. CONCLUSIONS: BP trajectories in pregnancy are different between patients with CHTN with PEC, CHTN without PEC, and patients with normal BP. These findings may be useful in assessing patients' risks for developing preeclampsia during pregnancy.
Subject(s)
Blood Pressure , Hypertension , Pre-Eclampsia , Humans , Pregnancy , Female , Retrospective Studies , Adult , Pre-Eclampsia/physiopathology , Hypertension/physiopathology , Gestational Age , Pregnancy Outcome , Case-Control Studies , Pregnancy Complications, Cardiovascular/physiopathology , Severity of Illness Index , Chronic DiseaseABSTRACT
BACKGROUND: Patients with obesity experience an increased duration of labor with an increased risk for perinatal morbidity. When compared with parturients without obesity, they also experience fewer uterine contractions after administration of misoprostol. It is unclear if the same dose of misoprostol should be used for induction of labor in patients with obesity compared to non-obese patients. Therefore, we sought to investigate if a higher dose of misoprostol for patients with obesity is more effective. OBJECTIVE: This study aimed to determine if 50 µg compared with 25 µg of vaginal misoprostol reduced the time from induction start to delivery among patients with obesity. STUDY DESIGN: We performed a double-blinded, pragmatic randomized controlled trial, between June 1, 2022, and July 17, 2023. Patients with a body mass index ≥30 kg/m2 who underwent labor induction at ≥ 36 weeks' gestation, had a singleton gestation, and a cervical dilation ≤3 cm at admission were included. Patients were excluded if they had a contraindication to vaginal delivery or misoprostol administration. Patients were randomized to 25 or 50 µg of vaginal misoprostol, stratified by parity, body mass index <40 kg/m2 or ≥40 kg/m2, and provider intent to use mechanical dilation at the onset of labor induction. Usual labor management was followed at the discretion of the provider. The primary outcome was time from induction to delivery. A priori, we estimated that 90 subjects per group (N=180) were needed for an 85% power to detect a 3-hour difference between groups with a type I error of 5%. Analysis was by intention-to-treat. A 2-sample t test was used for the primary outcome, Cohen's d was used as a measure of effect, and P values were reported. RESULTS: Of the 180 patients randomized, 88 were assigned to the 25 µg group and 92 were assigned to the 50 µg group. Of those, 96.1% of patients received the designated intervention. The baseline characteristics were similar between groups. No difference was found in the primary outcome of time to delivery (21.6 hours vs 18.6 hours; d=.28; 95% confidence interval, -0.02 to 0.57). In a planned subgroup analysis, multiparous patients delivered faster in the 50 µg group (15.2 hours vs 12.0 hours; d=.51; 95% confidence interval, 0.04-0.97). The risk for tachysystole associated with fetal heart tracing changes was rare overall (2.2%) and not significantly different between groups. No differences in maternal or neonatal adverse effects were observed. CONCLUSION: Patients with obesity who underwent cervical ripening with 50 µg of vaginal misoprostol experienced a similar time to delivery when compared with those who received 25 µg of misoprostol. However, multiparous patients had a significantly reduced time to delivery when 50 µg was used. A higher dose of misoprostol may be a promising intervention for reducing time in labor, which warrants further study.
Subject(s)
Body Mass Index , Labor, Induced , Misoprostol , Oxytocics , Adult , Female , Humans , Pregnancy , Administration, Intravaginal , Dose-Response Relationship, Drug , Double-Blind Method , Labor, Induced/methods , Misoprostol/administration & dosage , Obesity , Oxytocics/administration & dosage , Time FactorsSubject(s)
Labor, Induced , Urinary Catheterization , Humans , Female , Pregnancy , Urinary Catheterization/adverse effects , Catheters , StreptococcusABSTRACT
OBJECTIVE: To develop a predictive model for peripartum infection among high risk laboring patients in Cameroon, Africa. STUDY DESIGN: We conducted a secondary analysis of the Cameroon Antibiotic Prophylaxis Trial (NCT03248297), a multicenter 3-arm double-blind randomized controlled trial of oral azithromycin ± amoxicillin among term pregnancies with prolonged labor or rupture of membranes in Cameroon 1/2018-5/2020. Patients with chorioamnionitis prior to randomization, study drug contraindications, or planned cesarean were excluded. The outcome of interest was a composite of maternal peripartum infection (chorioamnionitis, endometritis, sepsis by World Health Organization criteria, wound infection/abscess) diagnosed up to 6 weeks postpartum. Potential predictors were compared between patients with and without the composite outcome, and evaluated at a 0.05 alpha level. Statistically significant exposures were analyzed using multivariable regression (to generate adjusted odds ratios and 95 % confidence intervals) with backwards selection to generate a parsimonious model. Receiver operating characteristic curves with associated area under the curve assessed the model's predictive ability. A nomogram based on the final best fit multivariable model was constructed. RESULTS: Of 756 patients in the parent trial, 652 were analyzed: 45 (7 %) had peripartum infection. Those with infection were more likely to be nulliparous, lower education level, higher gestational age, receive antibiotics per hospital protocols, and undergo cesarean. In our best-fit multivariable model, none/primary education (vs university), cesarean birth, and antibiotic receipt per physician discretion (vs for cesarean prophylaxis) were significantly associated with increased infection risk. This model was moderately predictive (AUC = 0.75, 95 % CI 0.67-0.82). When using this 3 factor model, for a patient with a cesarean birth, receipt of antibiotics per physician discretion, and university education, the probability of peripartum infection was 35 % (95 % CI 0.11-0.73). CONCLUSIONS: While several variables such as parity are associated with infectious morbidity within 6 weeks among high risk laboring patients in Cameroon, only education level, antibiotic indication, and cesarean birth were independently associated, and a model including these 3 factors was moderately predictive. Validation of our findings in a larger population is warranted.
Subject(s)
Chorioamnionitis , Labor, Obstetric , Humans , Pregnancy , Female , Chorioamnionitis/epidemiology , Cameroon/epidemiology , Peripartum Period , Anti-Bacterial Agents/therapeutic useABSTRACT
OBJECTIVE: The safety of weight loss and low weight gain during pregnancy remains unclear. To determine how different patterns of gestational weight gain (GWG), including weight loss, stability, and low GWG relate to perinatal outcomes by prepregnancy obesity class. STUDY DESIGN: The study population included 29,408 singleton livebirths among pregnant people with obesity from Kaiser Permanente Northern California (2008-2013). Clinically measured GWG was grouped into meaningful categories (Adequate: reference, met 2009 National Academy of Medicine [NAM] Guidelines [5-9.1 kg], Excessive [>9.1 kg], Low [1-4.9 kg], Stable [±1 kg], Weight Loss [>1 kg]) or GWG Z-score quintiles. Modified Poisson regression was used to estimate risk of adverse outcomes, stratified by obesity class. Electronic health record data were used to define outcomes, including cesarean delivery, preterm birth, admission to the neonatal intensive care unit, small- and large-for-gestational age infants. RESULTS: Prevalence of weight stability and weight loss was 3.8 and 3.4%, respectively. Compared with those who gained within NAM, increased risk of small-for-gestational age was observed among those with weight loss among obesity class I (Risk Ratio (RR): 1.57, 95% confidence interval [CI]: 1.12, 2.19), obesity class II (RR: 2.18, 95% CI: 1.52, 3.13), and obesity class III (RR: 1.72, 95% CI: 1.21, 2.45). Weight loss was associated with a decreased risk of cesarean delivery among obesity class III, compared with NAM. CONCLUSION: Weight loss during pregnancy is associated with increased risk of small-for-gestational age among all obesity classes, but not other adverse perinatal outcomes and may reduce risk of cesarean delivery. Low weight gain and weight stability are not associated with risk of adverse outcomes among those with class III obesity. GWG guidelines may need to vary by obesity class. KEY POINTS: · Weight loss during pregnancy is associated with increased risk of small-for-gestational age among all obesity classes; but weight loss was not associated with other adverse perinatal outcomes.. · Among class III, low weight gain and weight stability are not associated with adverse perinatal outcomes.. · GWG guidelines may need to vary by obesity class..
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BACKGROUND: Leptin resistance occurs with obesity, but it is unknown if individuals at risk for obesity develop leptin resistance prior to obesity. OBJECTIVE: Investigate whether leptin resistance is independent of weight status in children at risk for obesity due to intrauterine exposure to maternal obesity or gestational diabetes mellitus (GDM). METHODS: Mother-child dyads (N = 179) were grouped by maternal pregnancy weight and GDM status: (1) normal weight, no GDM; (2) overweight/obesity, no GDM; (3) overweight/obesity with GDM. Children (4-10 years) were further stratified by current body mass index (BMI) <85th or ≥85th percentile. Leptin resistance of children and mothers was calculated as fasting leptin/fat mass index. Two-way ANOVA was used to assess whether leptin concentrations and leptin resistance differed by current weight status or in utero exposure group, after adjusting for race, sex and Tanner stage. RESULTS: Children with a BMI ≥85th percentile had more leptin resistance than those with a BMI <85th percentile (p < 0.001), but leptin resistance did not differ by in utero exposure. Similarly, leptin resistance in women was associated with weight status and not prior GDM. CONCLUSIONS: Results suggest that leptin concentrations are associated with obesity but not risk for obesity based on in utero exposure to maternal obesity or GDM.
Subject(s)
Diabetes, Gestational , Obesity, Maternal , Female , Humans , Pregnancy , Birth Weight , Body Mass Index , Diabetes, Gestational/epidemiology , Leptin , Obesity/epidemiology , Obesity/complications , Obesity, Maternal/complications , Overweight/complications , Risk Factors , Child, Preschool , ChildABSTRACT
OBJECTIVE: To evaluate the efficacy of occipital nerve block compared with standard care , defined as acetaminophen with caffeine, for treatment of acute headache in pregnancy. METHODS: We conducted a single-center, unblinded, parallel, randomized controlled trial of pregnant patients with headache and pain score higher than 3 on the visual rating scale. Patients with secondary headache, preeclampsia, or allergy or contraindication to study medications were excluded. Participants were randomized to occipital nerve block or standard care (oral 650 mg acetaminophen and 200 mg caffeine). Crossover treatment was given at 2 hours and second-line treatment at 4 hours to those with worsening visual rating scale score or visual rating scale score higher than 3. The primary outcome was headache improvement to a visual rating scale score of 3 or lower within 2 hours of initial therapy. Secondary outcomes included serial visual rating scale scores, receipt of crossover or second-line therapy, patient satisfaction, and perinatal outcomes. Outcomes were assessed in an intention-to-treat analysis. We estimated that a sample of 62 would provide 80% power to detect a difference from 85% to 50% between groups. RESULTS: From February 2020 to May 2022, 62 participants were randomized to occipital nerve block (n=31) or standard care (n=31). Groups were similar except payer status. The primary outcome, headache improvement to visual rating scale score of 3 or lower, was not significantly different between groups (64.5% vs 51.6%, P =.30). The occipital nerve block group experienced lower median [interquartile range] visual rating scale scores at 1 hour (2 [0-5] vs 6 [2-7], P =.014), and more patients in the occipital nerve block group had visual rating scale scores of 3 or lower at 1 hour. Among patients receiving crossover treatment at 2 hours, the standard care group had a significantly lower visual rating scale score 1 hour after crossover to occipital nerve block than the occipital nerve block group receiving crossover to standard care ( P =.028). There were no significant differences in second-line treatment, refractory headache, satisfaction, or complications. Patients receiving occipital nerve block delivered earlier (36.6 weeks vs 37.8 weeks), but preterm birth did not differ between groups. CONCLUSION: Occipital nerve block is an effective and quick-acting treatment option for acute headache in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT03951649.
Subject(s)
Nerve Block , Premature Birth , Infant, Newborn , Female , Humans , Pregnancy , Acetaminophen/therapeutic use , Caffeine , Anesthetics, Local , Treatment Outcome , Headache/drug therapyABSTRACT
OBJECTIVE: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes. METHODS: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA). RESULTS: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA. CONCLUSION: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.
Subject(s)
Hypertension , Pre-Eclampsia , Premature Birth , Pregnancy , Humans , Infant, Newborn , Female , Pre-Eclampsia/epidemiology , Pre-Eclampsia/etiology , Premature Birth/epidemiology , Placenta , Pregnancy Outcome , Fetal Growth Retardation , Hypertension/drug therapy , Hypertension/epidemiology , Hypertension/complicationsABSTRACT
BACKGROUND: Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown. OBJECTIVE: This study aimed to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed according to perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg). STUDY DESIGN: We performed a secondary analysis of the Chronic Hypertension and Pregnancy trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferred treatment until blood pressure ≥160/105 mm Hg (control). The primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit. RESULTS: Of the 2408 participants from the Chronic Hypertension and Pregnancy trial, 1444 (60%) attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean durations of breastfeeding were 6.5±2.3 and 6.3±2.1 weeks, respectively. The probability of ever breastfeeding (adjusted relative risk, 0.99; 95% confidence interval, 0.93-1.05), current breastfeeding at postpartum visit (adjusted relative risk, 1.01; 95% confidence interval, 0.94-1.10), and weeks of breastfeeding (adjusted odds ratio, 0.87; 95% confidence interval, 0.68-1.12) did not differ by treatment group. Increased duration (≥2 vs <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models. CONCLUSION: In a secondary analysis of the cohort of Chronic Hypertension and Pregnancy trial participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals.
Subject(s)
Breast Feeding , Hypertension , Pregnancy , Female , Humans , Antihypertensive Agents/adverse effects , Hypertension/diagnosis , Hypertension/drug therapy , Hypertension/epidemiology , Blood Pressure , Postpartum PeriodABSTRACT
BACKGROUND: Despite the known benefits of breastfeeding to infants and mothers, previous studies have demonstrated that underserved women are less likely to exclusively breastfeed. Existing studies on the impact of Special Supplemental Nutritional Program for Women, Infants, and Children enrollment on feeding decisions for infants have conflicting results with low-quality data and metrics. OBJECTIVE: This study aimed to examine infant feeding trends nationally in the first week postpartum over a 10-year period, comparing breastfeeding rates for primiparous women with low income who used Special Supplemental Nutritional Program for Women, Infants, and Children resources with those women who did not enroll. We hypothesized that although the Special Supplemental Nutritional Program for Women, Infants, and Children is an important resource for new mothers, free formula associated with enrollment in the Special Supplemental Nutritional Program for Women, Infants, and Children may disincentivize women to exclusively breastfeed. STUDY DESIGN: This was a retrospective cohort study of primiparous women with singleton gestations who gave birth at term and who responded to the Centers for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System between 2009 and 2018. Data were extracted from phases 6, 7, and 8 of the survey. Women with low income were defined as those with a reported annual household income of $35,000 or less. The primary outcome was exclusive breastfeeding after 1 week postpartum. Secondary outcomes included ever breastfeeding, any breastfeeding after 1 week postpartum, and introduction of other liquids within 1 week postpartum. Multivariable logistic regression was used to refine risk estimates with adjustment for mode of delivery, household size, education level, insurance status, diabetes, hypertension, race, age, and BMI. RESULTS: Among the 42,778 women with low income who were identified, 29,289 (68%) of these women reported receiving Special Supplemental Nutritional Program for Women, Infants, and Children resources. There was no significant difference in the rates of exclusive breastfeeding after 1 week postpartum between those enrolled in the Special Supplemental Nutritional Program for Women, Infants, and Children and those not enrolled (adjusted risk ratio, 1.04; 95% confidence interval, 1.00-1.07; P=.10). However, those enrolled were less likely to ever breastfeed (adjusted risk ratio, 0.95; 95% confidence interval, 0.94-0.95; P<.01) and were more likely to introduce other liquids within 1 week postpartum (adjusted risk ratio, 1.16; 95% confidence interval, 1.11-1.21; P<.01). CONCLUSION: Although exclusive breastfeeding rates after 1 week postpartum were similar, women enrolled in the Special Supplemental Nutritional Program for Women, Infants, and Children were significantly less likely to ever breastfeed and more likely to introduce formula within the first week postpartum. This suggests that Special Supplemental Nutritional Program for Women, Infants, and Children enrollment may impact the decision to initiate breastfeeding and may represent an important window to test future interventions.
Subject(s)
Breast Feeding , Mothers , Pregnancy , Infant , Female , United States , Child , Humans , Retrospective Studies , Postpartum Period , Surveys and QuestionnairesABSTRACT
OBJECTIVE: This study aimed to compare the risks of adverse perinatal outcomes by body mass index (BMI) categories in healthy pregnant individuals delivered by term elective repeat cesarean (ERCD) to describe an optimal timing of delivery in otherwise healthy patients at the highest-risk BMI threshold. STUDY DESIGN: A secondary analysis of a prospective cohort of pregnant individuals undergoing ERCD at 19 centers in the Maternal-Fetal Medicine Units Network from 1999 to 2002. Nonanomalous singletons undergoing prelabor ERCD at term were included. The primary outcome was composite neonatal morbidity; secondary outcomes included composite maternal morbidity and individual components of the composites. Patients were stratified by BMI classes and to identify a BMI threshold for which morbidity was the highest. Outcomes were then examined by completed week's gestation, between BMI classes. Multivariable logistic regression was used to calculate adjusted odds ratios (aOR) and 95% confidence intervals (CI). RESULTS: A total of 12,755 patients were included in analysis. Patient's with BMI ≥ 40 had the highest rates of newborn sepsis, neonatal intensive care unit admissions, and wound complications. While a weight-related response was observed between BMI class and neonatal composite morbidity (p < 0.001), only those with BMI ≥ 40 had significantly higher odds of composite neonatal morbidity (aOR: 1.4, 95% CI: 1.0-1.8). In analyses of patients with BMI ≥ 40 (n = 1,848), there was no difference in the incidence of composite neonatal or maternal morbidity across weeks' gestation at delivery; however, as gestational age approached 39 to 40 weeks, rates of adverse neonatal outcomes decreased, only to increase again at 41 weeks' gestation. Of note, the odds of the primary neonatal composite were the highest at 38 weeks compared with 39 weeks (aOR: 1.5, 95% CI: 1.1-2.0). CONCLUSION: Neonatal morbidity is significantly higher in pregnant individuals with BMI ≥40 delivering by ERCD. Despite this increased perinatal morbidity, delivery prior to 39 and after 41 weeks in these patients is associated with increased neonatal risks. KEY POINTS: · Obese patients without additional comorbidities have higher rates of neonatal morbidity.. · Patients with BMI ≥ 40 carry the highest odds of poor perinatal outcomes.. · Earlier timing of delivery does not appear to reduce this risk..
ABSTRACT
OBJECTIVE: To evaluate how Texas health care professionals who care for patients experiencing medically complex pregnancies navigate abortion restrictions. METHODS: We conducted qualitative in-depth interviews with health care professionals across Texas who cared for patients with life-limiting fetal diagnoses or who had existing or developed health conditions that adversely affected pregnancy. We conducted the first round of interviews March-June 2021 and the second round of interviews January-May 2022 after the implementation of Texas Senate Bill 8 (SB8), which prohibited most abortions after detection of embryonic cardiac activity. We used inductive and deductive qualitative analysis to identify themes and changes in practice after the implementation of SB8. RESULTS: We conducted a total of 50 interviews: 25 before implementation of SB8 and 25 after the law's implementation. We interviewed 21 maternal-fetal medicine specialists, 19 obstetrician-gynecologists, eight physicians whose primary practice is the provision of abortion care, and two genetic counselors. Participants reported presenting their patients with information about health risks and outcomes of continued pregnancy in each policy period; however, counseling on these options was curtailed after implementation of SB8. Even in cases in which a patient's health and, in some cases, life would be compromised, narrow criteria for abortions at hospitals limited care before implementation of SB8, and criteria often became more stringent after implementation of SB8. Administrative approval processes and referrals for abortion delayed care and endangered patients' health, which worsened after in-state options were eliminated after implementation of SB8. Participants noted that patients with more limited resources who were unable to travel out of state often had to continue pregnancies, further increasing their risk of morbidity. CONCLUSION: Texas health care professionals' abilities to provide evidence-based abortion care to patients with medically complex pregnancies were constrained by institutional policies, and care options narrowed further after implementation of SB8. Abortion restrictions limit shared decision making, compromise patient care, and put pregnant people's health at risk.
Subject(s)
Abortion, Induced , Health Services Accessibility , Pregnancy , Female , Humans , Texas , Counseling , HospitalsABSTRACT
As the worldwide prevalence of overweight and obesity continues to rise, so too does the urgency to fully understand mediating mechanisms, to discover new targets for safe and effective therapeutic intervention, and to identify biomarkers to track obesity and the success of weight loss interventions. In 2016, the American Heart Association sought applications for a Strategically Focused Research Network (SFRN) on Obesity. In 2017, 4 centers were named, including Johns Hopkins University School of Medicine, New York University Grossman School of Medicine, University of Alabama at Birmingham, and Vanderbilt University Medical Center. These 4 centers were convened to study mechanisms and therapeutic targets in obesity, to train a talented cadre of American Heart Association SFRN-designated fellows, and to initiate and sustain effective and enduring collaborations within the individual centers and throughout the SFRN networks. This review summarizes the central themes, major findings, successful training of highly motivated and productive fellows, and the innovative collaborations and studies forged through this SFRN on Obesity. Leveraging expertise in in vitro and cellular model assays, animal models, and humans, the work of these 4 centers has made a significant impact in the field of obesity, opening doors to important discoveries, and the identification of a future generation of obesity-focused investigators and next-step clinical trials. The creation of the SFRN on Obesity for these 4 centers is but the beginning of innovative science and, importantly, the birth of new collaborations and research partnerships to propel the field forward.
Subject(s)
American Heart Association , Overweight , Animals , Humans , Overweight/epidemiology , Overweight/therapy , Obesity/epidemiology , Obesity/therapy , Causality , New YorkABSTRACT
OBJECTIVE: In the OFFSITE II randomized controlled trial, outpatient cervical ripening with a Foley catheter (CF) in nulliparous patients undergoing elective induction of labor (eIOL) shortened the time from admission to delivery. Given that patients with obesity have protracted labor and higher rates of failed IOL, we sought to determine if outpatient ripening with a CF may be even more beneficial for this high-risk group. STUDY DESIGN: We performed a secondary analysis of the OFFSITE II randomized controlled trial. For this analysis, all patients from the primary trial were classified by their intervention assignment (inpatient vs. outpatient) and also by their admission body mass index (BMI) class (BMI ≥ 30 and BMI < 30 kg/m2). The primary outcome was time from labor and delivery (L&D) admission to delivery. Secondary outcomes included cesarean delivery, time from admission to hospital discharge, and rates of clinically diagnosed chorioamnionitis and endometritis. RESULTS: In patients with BMI ≥ 30, the primary outcome, time from admission to delivery, (18.0 [13.5-20.9] vs. 20.4 [16.6-31.3] hours, p = 0.01), as well as total hospitalization length (3.2 [2.5-3.3] vs. 3.4 [3.1-4.3] days, p = 0.02) were shorter in the outpatient group. There were no differences in rates of chorioamnionitis or endometritis in outpatient compared with inpatient CF. Furthermore, in those with a BMI ≥ 30, the cesarean rate was significantly lower with outpatient CF (19.4% vs. 44.7%, p = 0.03); it was not statistically different in patients with BMI < 30. CONCLUSION: In this exploratory retrospective secondary analysis of the OFFSITE II randomized control trial, we found that in patients with BMI ≥ 30 undergoing eIOL, outpatient CF was associated with a lower time from L&D admission until delivery. This was also associated with a shorter time of total hospital duration and decreased the rate of cesarean, a benefit not detected in the overall analysis presented in the primary study. In nulliparas undergoing induction of labor, ripening with outpatient cervical Foley may even more significantly reduce labor duration, total hospital duration, and the rate of cesarean in patients with obesity. KEY POINTS: · Outpatient CF was associated with a lower time from L&D admission until delivery in obese nulliparas.. · Outpatient CF was associated with a shorter time of total hospital duration in obese nulliparas.. · Outpatient CF was associated with a decreased rate of cesarean birth in obese nulliparas..