Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: More than 1 million women have their labor induced in the United States each year, and synthetic oxytocin infusion is the most common method used. However, compared to spontaneous labor, medical induction is resource intensive, has increased obstetric risks, and is associated with less successful breastfeeding. In contrast to the endogenous oxytocin hormone, which is released in a pulsatile fashion in the brain, synthetic oxytocin is continuously infused intravenously, resulting in important limitations related to efficacy, safety, and cost. Akin to spontaneous labor contractions, infant suckling of the breast nipple is known to stimulate the pulsatile release of endogenous oxytocin from the posterior pituitary gland. Nipple stimulation therapy via an electric breast pump similarly stimulates endogenous oxytocin release and may be a favorable inpatient method for patients undergoing labor induction. OBJECTIVE: This study aims to examine whether inpatient nipple stimulation therapy is an efficacious labor induction method that increases the likelihood of spontaneous vaginal delivery and sustained breastfeeding and determine whether it is a cost-effective approach. METHODS: This is a multicenter, pragmatic, open-label, parallel-group randomized controlled trial of nulliparous patients with singleton gestations ≥36 weeks undergoing labor induction. This trial compares inpatient nipple stimulation therapy via an electric breast pump versus immediate synthetic oxytocin infusion without nipple stimulation. This trial including 988 nulliparas will provide adequate statistical power to detect clinically meaningful differences in delivery mode and breast milk as the sole source of nutrition for newborns at hospital discharge or 72 hours after birth. RESULTS: The project received pilot funding in 2021 and full funding in 2023. Enrollment for this study began in November 2021 at a single site, and as of May 2024, recruitment is underway at 3 study sites. It is anticipated that enrollment will be completed by late 2026. CONCLUSIONS: Successful completion of this trial will provide rigorous data to determine whether inpatient nipple stimulation therapy with an electric breast pump can improve the way we induce labor and positively impact breastfeeding success and early infant nutrition through lactation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05079841; https://clinicaltrials.gov/study/NCT05079841. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63463.

Nonadjuvanted Bivalent Respiratory Syncytial Virus Vaccination and Perinatal Outcomes.

Importance: A nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF [Pfizer]) protein subunit vaccine was newly approved and recommended for pregnant individuals at 32 0/7 to 36 6/7 weeks' gestation during the 2023 to 2024 RSV season; however, clinical vaccine data are lacking. Objective: To evaluate the association between prenatal RSV vaccination status and perinatal outcomes among patients who delivered during the vaccination season. Design, Setting, and Participants: This retrospective observational cohort study was conducted at 2 New York City hospitals within 1 health care system among patients who gave birth to singleton gestations at 32 weeks' gestation or later from September 22, 2023, to January 31, 2024. Exposure: Prenatal RSV vaccination with the RSVpreF vaccine captured from the health system's electronic health records. Main Outcome and Measures: The primary outcome is preterm birth (PTB), defined as less than 37 weeks' gestation. Secondary outcomes included hypertensive disorders of pregnancy (HDP), stillbirth, small-for-gestational age birth weight, neonatal intensive care unit (NICU) admission, neonatal respiratory distress with NICU admission, neonatal jaundice or hyperbilirubinemia, neonatal hypoglycemia, and neonatal sepsis. Logistic regression models were used to estimate odds ratios (ORs), and multivariable logistic regression models and time-dependent covariate Cox regression models were performed. Results: Of 2973 pregnant individuals (median [IQR] age, 34.9 [32.4-37.7] years), 1026 (34.5%) received prenatal RSVpreF vaccination. Fifteen patients inappropriately received the vaccine at 37 weeks' gestation or later and were included in the nonvaccinated group. During the study period, 60 patients who had evidence of prenatal vaccination (5.9%) experienced PTB vs 131 of those who did not (6.7%). Prenatal vaccination was not associated with an increased risk for PTB after adjusting for potential confounders (adjusted OR, 0.87; 95% CI, 0.62-1.20) and addressing immortal time bias (hazard ratio [HR], 0.93; 95% CI, 0.64-1.34). There were no significant differences in pregnancy and neonatal outcomes based on vaccination status in the logistic regression models, but an increased risk of HDP in the time-dependent model was seen (HR, 1.43; 95% CI, 1.16-1.77). Conclusions and Relevance: In this cohort study of pregnant individuals who delivered at 32 weeks' gestation or later, the RSVpreF vaccine was not associated with an increased risk of PTB and perinatal outcomes. These data support the safety of prenatal RSVpreF vaccination, but further investigation into the risk of HDP is warranted.

Trial of labor after cesarean, vaginal birth after cesarean, and the risk of uterine rupture: an expert review.

The decision to pursue a trial of labor after cesarean delivery is complex and depends on patient preference, the likelihood of successful vaginal birth after cesarean delivery, assessment of the risks vs benefits of trial of labor after cesarean delivery, and available resources to support safe trial of labor after cesarean delivery at the planned birthing center. The most feared complication of trial of labor after cesarean delivery is uterine rupture, which can have catastrophic consequences, including substantial maternal and perinatal morbidity and mortality. Although the absolute risk of uterine rupture is low, several clinical, historical, obstetrical, and intrapartum factors have been associated with increased risk. It is therefore critical for clinicians managing patients during trial of labor after cesarean delivery to be aware of these risk factors to appropriately select candidates for trial of labor after cesarean delivery and maximize the safety and benefits while minimizing the risks. Caution is advised when considering labor augmentation and induction in patients with a previous cesarean delivery. With established hospital safety protocols that dictate close maternal and fetal monitoring, avoidance of prostaglandins, and careful titration of oxytocin infusion when induction agents are needed, spontaneous and induced trial of labor after cesarean delivery are safe and should be offered to most patients with 1 previous low transverse, low vertical, or unknown uterine incision after appropriate evaluation, counseling, planning, and shared decision-making. Future research should focus on clarifying true risk factors and identifying the optimal approach to intrapartum and induction management, tools for antenatal prediction, and strategies for prevention of uterine rupture during trial of labor after cesarean delivery. A better understanding will facilitate patient counseling, support efforts to improve trial of labor after cesarean delivery and vaginal birth after cesarean delivery rates, and reduce the morbidity and mortality associated with uterine rupture during trial of labor after cesarean delivery.

Association Between Intrapartum Nitrous Oxide for Labor Analgesia and Short-Term Neonatal Outcomes.

OBJECTIVE: To evaluate the association between intrapartum nitrous oxide use and adverse short-term neonatal outcomes. METHODS: This was a retrospective cohort study of individuals with singleton gestations at 35 or more weeks who attempted labor and delivered at an academic hospital between June 1, 2015, and February 28, 2020. Data were extracted from the electronic medical record using billing and diagnostic codes. Patients were classified based on whether they received no intrapartum analgesia or received nitrous oxide only. Those who received other analgesia types were excluded. The primary outcome was neonatal intensive care unit (NICU) admission. Secondary outcomes included Apgar score less than 7 at 1 minute and 5 minutes, respiratory composite outcome (including meconium aspiration syndrome, neonatal bronchopulmonary disorders, neonatal transient tachypnea, and other neonatal respiratory distress that required NICU admission), hypoglycemia, and hyperbilirubinemia. Univariable and multivariable analyses were used to estimate the association between nitrous oxide exposure intrapartum and the selected outcomes. RESULTS: Of 6,047 included, 4,153 (68.7%) received no analgesia, and 1,894 (31.3%) received nitrous oxide only. In comparison with individuals who received no analgesia, those who received nitrous oxide were more likely to be nulliparous, be of Black racial identity, have noncommercial insurance, and be less likely to deliver by intrapartum cesarean. The reception of nitrous oxide, compared with the reception of no analgesia, was associated with a lower likelihood of NICU admission (6.4% vs 8.1%; adjusted odds ratio [aOR] 0.77, 95% CI, 0.62-0.96) and an increased likelihood of neonatal hyperbilirubinemia (aOR 1.23, 95% CI, 1.08-1.41). Inhaled nitrous oxide exposure, in comparison with the reception of no analgesia, was not associated with the other secondary outcomes, including Apgar score less than 7 at 1 minute (odds ratio [OR] 0.74, 95% CI, 0.50-1.10) or 5 minutes (OR 0.91, 95% CI, 0.32-2.60), respiratory composite outcome (OR 0.91, 95% CI, 0.70-1.17), and hypoglycemia (OR 0.82, 95% CI, 0.64-1.05). CONCLUSION: In this single-center retrospective cohort of low-risk patients, intrapartum inhaled nitrous oxide, compared with the reception of no analgesia, was associated with a decreased risk for NICU admission but with an increased risk for hyperbilirubinemia; other outcomes did not differ. These findings may be used to counsel patients when considering nitrous oxide for labor analgesia.

The Cost of Developing and Implementing an Antepartum Referral Program for Penicillin Allergy Evaluation at a Single Academic Tertiary Care Hospital.

OBJECTIVE: Approximately 10% of pregnant individuals report a penicillin allergy, yet most are not truly allergic. Allergy verification during pregnancy is safe and recommended; however, many hospitals lack the infrastructure to execute testing. Our aim was to evaluate the cost of developing and implementing a penicillin allergy referral program for pregnant individuals at an academic institution and to compare costs of care between patients who were referred and not referred through the program. STUDY DESIGN: We conducted an economic analysis of our institution's antepartum penicillin allergy referral program. We prospectively collected detailed resource utilization data and conducted the analysis from the program's perspective, accounting for costs related to program development, allergy verification, antibiotic cost, and delivery hospitalization. Costs were compared between patients who were referred for evaluation versus patients who were not referred using bivariate tests as well as quantile regression adjusting for baseline differences. A sensitivity analysis was performed for allergy testing cost. All cost estimates were inflation adjusted to 2021 U.S. dollars. RESULTS: The startup cost of program development and educational initiatives was $19,920, or 86 per patient. The median allergy evaluation cost was $397 (interquartile range: $303-663). There was no significant difference in maternal (median: $13,579 vs. 13,999, p = 0.94) or neonatal (median: $3,565 vs. 3,577, p = 0.55) delivery hospitalization cost or antibiotic cost (median: $1.57 vs. 3.87, p = 0.10) between referred and nonreferred patients. Overall, the total cost per person did not differ significantly between study groups (median: $18,931 vs. 18,314, p = 0.69). CONCLUSION: The cost of developing a penicillin allergy referral program in pregnancy was modest and did not significantly alter short-term cost of care with potential for long-term cost benefit. Verification of a reported penicillin allergy is an integral part of antibiotic stewardship, and the pregnancy period should be utilized as an important opportunity to perform this evaluation. KEY POINTS: · The cost of developing and implementing an antepartum penicillin allergy referral program is modest.. · Program cost did not significantly alter short-term cost with a potential for long-term cost benefit.. · Penicillin allergy verification is an important part of antibiotic stewardship and should be expanded..

Co-existing chronic hypertension and hypertensive disorders of pregnancy and associated adverse pregnancy outcomes.

OBJECTIVE: Chronic hypertension (CHTN) causes vascular damage and resistance in the pregnant person and malperfusion in the placenta which may worsen the endothelial dysfunction of hypertensive disorders of pregnancy (HDP). These conditions frequently co-exist. A cumulative effect has been inconsistently demonstrated in prior studies, and it is unclear how co-existing hypertensive conditions affect pregnancy outcomes. We sought to examine maternal and neonatal outcomes in pregnancies affected by co-existing CHTN and HDP and compare these outcomes to those of pregnancies which were unaffected or affected by either condition alone. METHODS: This is a retrospective cohort study of singleton deliveries at a single institution 1 October 2013 to 1 October 2021. Data were extracted from the electronic medical record using standardized definitions and billing and diagnosis codes. Pregnant people with no evidence of hypertensive condition were compared to those with CHTN only, HDP only, and co-existing CHTN and HDP. Demographics, baseline clinical data, and use of aspirin or antihypertensive medications were assessed. Maternal outcomes included cesarean delivery, critical range blood pressure, intensive care unit (ICU) admission, and death. Neonatal outcomes included preterm birth <37 weeks' gestation, small for gestational age (SGA) birthweight, ICU admission, and a morbidity composite. Bivariate tests of association were performed using Chi-square test. Crude and adjusted odds ratios (aORs) were calculated using logistic regression for three maternal and four neonatal outcomes. Descriptive statistics and multivariable analyses were performed. RESULTS: Of 40,840 eligible people, 1451 (3.6%) had CHTN only; 5213 (12.8%) had HDP only; and 1890 (4.6%) had co-existing CHTN and HDP. Though odds of adverse maternal and neonatal outcomes were significantly increased for all hypertensive groups relative to the unaffected referent group, co-existing CHTN and HDP had the highest odds of cesarean delivery (aOR 1.60; 95% confidence interval (CI) 1.45-1.77), critical blood pressure (OR 41.54; 95% CI 35.96-47.99), maternal ICU admission or death (aOR 3.52; 95% CI 2.65-4.67), preterm birth (aOR 2.76; 95% CI 2.41-3.16), and SGA birthweight (aOR 1.61; 95% CI 1.39-1.87). CONCLUSIONS: Hypertensive disorders of pregnancy in the setting of CHTN are associated with the highest odds of serious consequences on the pregnant person and neonate independent of maternal comorbidities and prematurity. Antihypertensive medication use lowers the odds of some adverse outcomes. Patients should be informed of heightened risks, but optimal management remains unclear.

Using a Patient Educational Video to Improve Knowledge of Maternal Mortality Warning Signs: A Randomized Controlled Trial.

OBJECTIVE: To determine whether a community-informed, language-concordant postpartum video education campaign, developed with community input, improves patients' knowledge of warning signs for postpartum maternal mortality (infection, hemorrhage, hypertensive disorders, and postpartum depression) compared with routine discharge procedures. METHODS: A single-center, investigator-blinded, parallel-group randomized controlled trial of postpartum individuals who delivered at a large, urban, tertiary care hospital. Eligible participants were enrolled and completed a baseline knowledge questionnaire. After delivery, they were randomized to routine discharge education (control) or routine education plus video education (intervention). After discharge education, patient knowledge was again assessed in both groups before participants left the hospital. The primary outcome was the percentage of participants who showed improvement in their knowledge, measured by the number of correct questionnaire responses after education compared with their baseline, assessed as a binary outcome. A sample size of 150 (75 per group) was planned to detect a 25% absolute increase in the frequency of the primary outcome. RESULTS: From July to August 2022, 296 participants were screened and 200 were randomized (100 per group). Eighty-two percent of participants had college or graduate education, and 71.5% had commercial insurance. There was no significant difference in baseline characteristics. There was no statistically significant difference in the percentage of participants who improved their scores between the baseline and posteducation questionnaires (64.5% vs 50.0%, P =.09). However, the median posteducation questionnaire total score was significantly higher in the video education group (14 [interquartile range 12-15] vs 13 [interquartile range 12-14], P =.003). In addition, they more frequently reported that video education was "very helpful" (83.9% vs 72.5%, P =.23) and that they were "very satisfied" with their education (86.1% vs 75.5%, P =.29). CONCLUSION: Enhanced postpartum education through a novel video did not result in a statistically significant difference in frequency of improved score on the posteducation questionnaires but was associated with increased satisfaction with care. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05159726.

The association between a low 50-gram, 1-hour glucose challenge test value and neonatal morbidity.

OBJECTIVE: To evaluate the association between a low 50-gram, 1-hour glucose challenge test (GCT) value and adverse maternal and neonatal outcomes among patients receiving care at a single center tertiary care academic hospital. METHODS: We performed a retrospective cohort study of pregnant patients with a documented result of a 50-gram, 1-hour GCT performed ≥24 weeks 0 days gestation at a single tertiary care academic hospital from 2013-2021. Patients with a low GCT value, defined as cohort specific ≤10th percentile (<82 mg/dL), were compared to patients with a GCT value ≥82 mg/dL who were not diagnosed with gestational diabetes (GDM) to examine adverse maternal and neonatal outcomes. Additionally, these comparisons were repeated across patients with low GCT (<82 mg/dL), those with a GCT ≥82 mg/dL without diagnosis of GDM (heretofore referred to as normal glycemic screening) and patients diagnosed with GDM. Our primary outcome was a composite neonatal morbidity variable, inclusive of stillbirth, neonatal death, neonatal hypoglycemia with neonatal intensive care unit (NICU) admission, neonatal hyperbilirubinemia with NICU admission, respiratory distress with NICU admission, and/or small for gestational age (SGA). Multivariable logistic regression modeling was used to examine the association of low GCT value and the composite neonatal morbidity outcome, compared to those with the normal glycemic screening. RESULTS: Of 36,342 eligible patients, 3,789 (10.4%) had a low GCT value of <82 mg/dL, 30,729 (84.6%) had a GCT value ≥82 mg/dL and were not diagnosed with GDM, and 1,824 (5.0%) had a diagnosis of GDM. Patients with a low GCT value were significantly less likely to be diagnosed with hypertensive disorder of pregnancy (HDP) (12.4% vs 16.3%, p < .01), undergo cesarean delivery (22.8% vs 29.9%, p < .01), or experience postpartum hemorrhage (7.8% vs 9.4%, p < .01) as compared to patients with normal glycemic screening. Compared to newborns whose mothers had normal glycemic screening, newborns of mothers with a low GCT value were significantly more likely to experience the composite morbidity outcome (OR 1.17; 95% CI 1.08-1.27); this persisted after adjusting for potential confounders (aOR 1.18; 95% CI 1.09-1.29). CONCLUSION: A low maternal GCT value after 24 weeks gestation is significantly associated with an increased risk of morbidity in the newborn, driven by higher rates of SGA. Patients with a low GCT value may have underlying maternal hypoglycemia or other glycemic dysregulation affecting fetal development and may benefit from enhanced antenatal surveillance.

Fetal growth restriction and small for gestational age as predictors of neonatal morbidity: which growth nomogram to use?

BACKGROUND: Fetal growth nomograms were developed to screen for fetal growth restriction and guide clinical care to improve perinatal outcomes; however, existing literature remains inconclusive regarding which nomogram is the gold standard. OBJECTIVE: This study aimed to compare the ability of 4 commonly used nomograms (Hadlock, International Fetal and Newborn Growth Consortium for the 21st Century, Eunice Kennedy Shriver National Institute of Child Health and Human Development-unified standard, and World Health Organization fetal growth charts) and 1 institution-specific reference to predict small for gestational age and poor neonatal outcomes. STUDY DESIGN: This was a retrospective cohort study of all nonanomalous singleton pregnancies undergoing ultrasound at ≥20 weeks of gestation between 2013 and 2020 and delivering at a single academic center. Using random selection methods, the study sample was restricted to 1 pregnancy per patient and 1 ultrasound per pregnancy completed at ≥22 weeks of gestation. Fetal biometry data were used to calculate estimated fetal weight and percentiles according to the aforementioned 5 nomograms. Maternal and neonatal data were extracted from electronic medical records. Logistic regression was used to estimate the association between estimated fetal weight of <10th and <3rd percentiles compared with estimated fetal weight of 10th to 90th percentile as the reference group for small for gestational age and the neonatal composite outcomes (perinatal mortality, hypoxic-ischemic encephalopathy or seizures, respiratory morbidity, intraventricular hemorrhage, necrotizing enterocolitis, hyperbilirubinemia or hypoglycemia requiring neonatal intensive care unit admission, and retinopathy of prematurity). Receiver operating characteristic curve contrast estimation (primary analysis) and test characteristics were calculated for all nomograms and the prediction of small for gestational age and the neonatal composite outcomes. We restricted the sample to ultrasounds performed within 28 days of delivery; moreover, similar analyses were completed to assess the prediction of small for gestational age and neonatal composite outcomes. RESULTS: Among 10,045 participants, the proportion of fetuses classified as <10th percentile varied across nomograms from 4.9% to 9.7%. Fetuses with an estimated fetal weight of <10th percentile had an increased risk of small for gestational age (odds ratio, 9.9 [95% confidence interval, 8.5-11.5] to 12.8 [95% confidence interval, 10.9-15.0]). In addition, the estimated fetal weight of <10th and <3rd percentile was associated with increased risk of the neonatal composite outcome (odds ratio, 2.4 [95% confidence interval, 2.0-2.8] to 3.5 [95% confidence interval, 2.9-4.3] and 5.7 [95% confidence interval, 4.5-7.2] to 8.8 [95% confidence interval, 6.6-11.8], respectively). The prediction of small for gestational age with an estimated fetal weight of <10th percentile had a positive likelihood ratio of 6.3 to 8.5 and an area under the curve of 0.62 to 0.67. Similarly, the prediction of the neonatal composite outcome with an estimated fetal weight of <10th percentile had a positive likelihood ratio of 2.1 to 3.1 and an area under the curve of 0.55 to 0.57. When analyses were restricted to ultrasound within 4 weeks of delivery, among fetuses with an estimated fetal weight of <10th percentile, the risk of small for gestational age increased across all nomograms (odds ratio, 16.7 [95% confidence interval, 12.6-22.3] to 25.1 [95% confidence interval, 17.0-37.0]), and prediction improved (positive likelihood ratio, 8.3-15.0; area under the curve, 0.69-0.75). Similarly, the risk of neonatal composite outcome increased (odds ratio, 3.2 [95% confidence interval, 2.4-4.2] to 5.2 [95% confidence interval, 3.8-7.2]), and prediction marginally improved (positive likelihood ratio, 2.4-4.1; area under the curve, 0.60-0.62). Importantly, the risk of both being small for gestational age and having the neonatal composite outcome further increased (odds ratio, 21.4 [95% confidence interval, 13.6-33.6] to 28.7 (95% confidence interval, 18.6-44.3]), and the prediction of concurrent small for gestational age and neonatal composite outcome greatly improved (positive likelihood ratio, 6.0-10.0; area under the curve, 0.80-0.83). CONCLUSION: In this large cohort, Hadlock, recent fetal growth nomograms, and a local population-derived fetal growth reference performed comparably in the prediction of small for gestational age and neonatal composite outcomes.

Pregnant Patients with a Documented History of Penicillin Allergy and Associated Maternal and Neonatal Outcomes at a Tertiary Care Center.

OBJECTIVE: Pregnant individuals are likely to need antibiotics during the peripartum period. For pregnant individuals who report a history of penicillin allergy, non-ß-lactam antibiotics are often administered. Compared with first-line ß-lactam antibiotics, alternative antibiotics can be less effective, more toxic, and more costly. It remains unclear if being labeled with a penicillin allergy is associated with adverse maternal and neonatal outcomes. STUDY DESIGN: We conducted a retrospective cohort study of all pregnant patients who delivered a viable singleton between 24 and 42 weeks of gestation at a large academic hospital from 2013 to 2021. We compared patients who had a documented penicillin allergy history in their electronic medical record versus those who did not and examined whether there were significant differences in maternal outcomes and neonatal outcomes. Bivariable and multivariable analyses were performed. RESULTS: Of 41,943 eligible deliveries included in the analysis, 4,705 (11.2%) patients had a penicillin allergy history documented in their electronic medical record and 37,238 (88.8%) did not. Even after adjusting for potential confounders, patients with a documented penicillin allergy had a higher risk of postpartum endometritis (adjusted odds ratio [aOR]: 1.46; 95% confidence interval [CI]: 1.01-2.11) and a higher risk of their neonates having a postnatal hospital stay lasting more than 72 hours (aOR: 1.10; 95% CI: 1.02-1.18). There were no significant differences seen in the other maternal and neonatal outcomes in both bivariable and multivariable analyses. CONCLUSION: Pregnant patients who are labeled as having a penicillin allergy are more likely to have postpartum endometritis, and neonates born to mothers who are labeled as having a penicillin allergy are more likely to have a postnatal hospital stay lasting more than 72 hours. There were no other significant differences seen in pregnant patients and their newborns whether they were labeled as having a penicillin allergy history or not. However, pregnant individuals with a penicillin allergy documented in their medical record were significantly more likely to receive alternative non-ß lactam antibiotics, and may have benefitted from having more details of their allergy history available as well as proper allergy verification with testing. KEY POINTS: · It is unclear whether pregnant individuals labeled with penicillin allergies have worse obstetric outcomes.. · These individuals were significantly more likely to have endometritis and their newborns hospitalized for >72 hours.. · They were significantly more likely to receive alternative non-ß lactam antibiotics than those without documented allergies..

Low-Dose Aspirin during Pregnancy and Postpartum Bleeding.

OBJECTIVE: This study aimed to investigate whether aspirin 81 mg daily for preeclampsia prevention is associated with increased risk of postpartum blood loss at the time of delivery. STUDY DESIGN: This is a retrospective cohort study performed at a tertiary hospital from January 2018 to April 2021. Data were extracted from the electronic medical record. Patients prescribed low-dose aspirin (LDA) were compared with patients who were not. The primary outcome was a composite of postpartum blood loss, defined as: estimated blood loss (EBL) >1,000 mL, documentation of International Classification of Diseases-9/-10 codes for postpartum hemorrhage (PPH), or red blood cell (RBC) transfusion. Bivariate analysis, and unadjusted and adjusted logistic regression modeling were performed. RESULTS: Among 16,980 deliveries, 1,922 (11.3%) were prescribed LDA. Patients prescribed LDA were more likely to be >35 years old, nulliparous, obese, taking other anticoagulants, or have diagnoses of diabetes, systemic lupus erythematosus, fibroids, or hypertensive disease of pregnancy. After adjusting for potential confounders, the significant association between LDA use and the composite did not persist (adjusted odds ratio [aOR]: 1.1, 95% confidence interval [CI]: 1.0-1.3) nor did the association between EBL > 1,000 mL (aOR: 1.0, 95% CI: 0.9-1.3) and RBC transfusion (aOR: 1.3, 95% CI: 0.9-1.7). The association between LDA and PPH remained significant (aOR: 1.3, 95% CI: 1.1-1.6). Patients who discontinued LDA <7 days prior to delivery had an increased risk of the postpartum blood loss composite compared discontinuation ≥7 days (15.0 vs. 9.3%; p = 0.03). CONCLUSION: There may be an association between LDA use and increased risk of postpartum bleeding. This suggests that use of LDA outside the recommended guidelines should be cautioned and further investigation is needed to determine its ideal dosing and timing of discontinuation. KEY POINTS: · There may be an association with LDA and an increased risk of postpartum bleeding.. · Patients who discontinued LDA less than 7 days prior to delivery had an increased rate of postpartum bleeding.. · Additional research is need to determine optimal LDA dose and timing of discontinuation..

Antibiotic choice for Group B Streptococcus prophylaxis in mothers with reported penicillin allergy and associated newborn outcomes.

OBJECTIVE: To evaluate the choice of antibiotic used for intrapartum Group B Streptococcus (GBS) prophylaxis in pregnant individuals with reported penicillin allergies compared to those without reported penicillin allergies and investigate whether there are associated differences in neonatal outcomes. STUDY DESIGN: This retrospective cohort study included mother-infant dyads of GBS positive pregnant individuals who labored and delivered newborns ≥ 35 weeks of gestation at a high-volume urban hospital (2005-2018). The type of antibiotic administered to the mothers for GBS prophylaxis (beta-lactam prophylaxis defined as penicillin-class drug or cefazolin; alternative prophylaxis defined as vancomycin or clindamycin) was compared between those with a penicillin allergy documented in their medical record versus those who did not. Neonatal outcomes included number of postnatal blood draws, antibiotic administration, neonatal intensive care unit (NICU) admission, bacteremia, and hospital length of stay and were compared between groups. Bivariable and multivariable analyses were performed. RESULTS: Of 11,334 mother-infant pairs, 1170 (10.3%) mothers had a penicillin allergy documented in their medical record. Of them, 49 (4.2%) received a penicillin, 259 (22.1%) received cefazolin, 449 (38.4%) received clindamycin, and 413 (35.3%) received vancomycin. Patients with a reported penicillin allergy were significantly more likely to receive alternative GBS prophylaxis compared to those without penicillin allergy (73.7% vs. 0.2%, p < 0.01). Neonates of patients who received alternative GBS prophylaxis were significantly more likely to undergo a postnatal lab draw compared to neonates of patients who received beta-lactam antibiotics (20.8% vs. 17.3%, OR 1.25 (95% CI 1.08-1.46)). This significant association persisted after adjusting for potential confounders (aOR 1.23, 95% CI 1.06-1.43). There were no other significant differences seen in other newborn outcomes. CONCLUSION: Pregnant individuals who report a penicillin allergy were more likely to receive alternative antibiotics for GBS prophylaxis compared to those without a penicillin allergy. This was associated with an increased frequency of postnatal blood draws among neonates of mothers with a reported penicillin allergy. Administration of alternative intrapartum antibiotic prophylaxis with vancomycin or clindamycin is common in individuals with self-reported penicillin allergy, and maternal alternative antibiotic administration may impact neonatal care, particularly via increased lab draws.

Intravenous iron for treatment of iron deficiency anemia during pregnancy and associated maternal outcomes.

BACKGROUND: More than 40% of pregnant patients worldwide are anemic, with at least half resulting from iron deficiency anemia (IDA). Anemia in pregnancy is linked with adverse maternal and neonatal outcomes. Treatment for IDA is iron supplementation; however, the optimal route of administration remains unclear. We sought to investigate whether patients with IDA who received intravenous iron (IVI) had decreased odds of maternal morbidity compared to patients who did not. METHODS: This is a retrospective cohort study of pregnant patients with presumed IDA with term deliveries at a tertiary hospital from 2013-2021. Data were extracted from the hospital's electronic medical record using standardized definitions and billing codes. Patients who received antepartum IVI were compared to patients who did not. The primary outcome was a maternal morbidity composite inclusive of receipt of blood transfusion, hysterectomy, admission to the intensive care unit or death. Bivariate analyses and multivariable logistic regression modelling were performed adjusting for potential confounders. RESULTS: Of 45,345 pregnancies, 5054 (11.1%) met eligibility criteria. Of these, 944 (18.7%) patients received IVI while 4110 (81.3%) did not. Patients who received IVI had higher risk baseline characteristics. They experienced a greater increase in hematocrit from pregnancy nadir to delivery admission (4.5% vs. 3.3%, p < .01). Despite this, patients who received IVI had higher odds of the maternal morbidity composite (OR 1.47, 95%CI 1.11-1.95). This finding persisted after adjusting for potential confounders, although the strength of the association became attenuated (aOR 1.37, 95%CI 1.02-1.85). Odds of the morbidity composite were not elevated among patients who received a full IVI treatment course (OR 1.2, 95% CI 0.83-1.90). DISCUSSION: Odds of the maternal morbidity composite were increased among patients who received IVI despite greater increases in hematocrit. The effect was attenuated after adjusting for potential confounders and was not significant among patients who completed a full treatment course.

Maximum Dose Rate of Intrapartum Oxytocin Infusion and Associated Obstetric and Perinatal Outcomes.

OBJECTIVE: Despite lack of evidence for a safety threshold for oxytocin dose rate, many hospital protocols specify a maximum rate. We investigated whether exceeding 20 milliunits/min of oxytocin was associated with adverse outcomes. METHODS: This is a secondary analysis of a double-blind, single-center, randomized controlled trial of nulliparous patients with singleton gestations at 36 weeks of gestation or later who presented in spontaneous labor randomized 1:1 to either a high-dose oxytocin titration regimen (initial-incremental rate of 6 milliunits/min) or standard-dose titration regimen (initial-incremental rate of 2 milliunits/min) for labor augmentation. A maximum oxytocin dose rate limit was not specified in the study protocol. For this secondary analysis, outcomes of participants who received oxytocin and exceeded a dose rate of 20 milliunits/min at any point in labor were compared with those whose rate remained at 20 milliunits/min or less. In addition, the cumulative proportions of labor and birth outcomes were calculated for each maximum dose rate of oxytocin reached among this study cohort. RESULTS: Of the 1,003 participants in the parent trial, 955 (95.2%) received oxytocin, as planned, and were included, with 190 (19.9%) exceeding a maximum dose rate of 20 milliunits/min. Those who exceeded 20 milliunits/min were older and were more likely to have rupture of membranes as their trial entry indication, have hypertensive disorders of pregnancy, receive intrapartum magnesium sulfate infusion, and receive oxytocin for longer. Those whose maximum rates exceeded 20 milliunits/min underwent cesarean delivery more frequently, but the majority (74%) still delivered vaginally. In multivariable analyses, there were no significant associations between maximum oxytocin dose rates greater than 20 milliunits/min and cesarean delivery (adjusted odds ratio [aOR] 1.57, 95% CI 1.00-2.46), peripartum infection (aOR 0.69, 95% CI 0.41-1.19), postpartum hemorrhage (aOR 1.37, 95% CI 0.70-2.71), or neonatal intensive care unit (NICU) admission (aOR 1.72, 95% CI 0.89-3.31). Although 85% of spontaneous vaginal deliveries occurred at maximum oxytocin dose rates of 20 milliunits/min or less, vaginal deliveries continued to occur at higher maximum dose rates. The cumulative proportions of NICU admissions and composite severe neonatal morbidity and mortality cases increased with increasing oxytocin dose rates even with maximum oxytocin dose rates at 20 milliunits/min or less. CONCLUSION: In multivariable analyses, there are no significant differences in maternal or perinatal adverse outcomes based on exceeding 20 milliunits/min of oxytocin. These data suggest that oxytocin dosing should be individualized to each patient and not be based on arbitrary thresholds. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02487797.

Management of the Pregnant Trauma Patient: A Systematic Literature Review.

INTRODUCTION: Trauma during pregnancy is the leading cause of non-obstetric maternal death and complicates up to 5%-7% of pregnancies. This systematic review without meta-analysis explores the current literature regarding the assessment and management of pregnant trauma patients to provide evidence-based recommendations to guide the general surgeon regarding the prognostic value of laboratory testing including Kleihauer-Betke testing, duration of maternal and fetal monitoring, the use of tranexamic acid, the safety of radiographic studies, and the utility of perimortem cesarean section to improve maternal and fetal mortality. MATERIALS AND METHODS: A systematic search of MEDLINE (Ovid), the Cochrane Library (Wiley), and Embase (Elsevier) was performed. The reference lists of included studies were reviewed for relevant citations. RESULTS: Of the 45 studies included in this review, there was reasonable evidence to suggest that the minimally injured pregnant trauma patient should be observed for a minimum of 4 h, CT scans to rule out traumatic injury are necessary and safe, perimortem cesarean sections should be performed as soon as maternal cardiac arrest occurs. CONCLUSIONS: We recommend delivery by perimortem cesarean section as soon as possible after maternal cardiac arrest, to provide TXA to the hemorrhaging pregnant trauma patient, to obtain trauma CT scans as indicated, and to observe the injured pregnant patient for a minimum of at least 4 h. Additional high-quality studies focusing on the prognostic potential of KB tests and other laboratory studies are needed.