Ambulation for latency during expectant management of preterm prelabor rupture of membranes: a randomized controlled trial (AMBLE).

BACKGROUND: Individuals hospitalized with preterm prelabor rupture of membranes are often advised to limit their activity or adhere to bed rest. Some evidence suggests that greater activity is associated with longer latency and improved outcomes, but no high-quality evidence from a randomized controlled trial exists. OBJECTIVE: This study aimed to evaluate whether encouragement to ambulate at least 2000 steps daily affects latency among individuals with preterm prelabor rupture of membranes compared with usual care. STUDY DESIGN: This was a multisite unblinded, 2-arm randomized trial of individuals at 23 0/7 to 35 0/7 weeks of gestation undergoing inpatient expectant management of preterm prelabor rupture of membranes with planned delivery at least 7 days away. Each participant wore a Fitbit Inspire that tracked steps. The intervention arm was encouraged (verbal and Fitbit-based reminders) to reach a goal of 2000 steps per day. The usual-care arm was allowed ad libitum activity with no step goal or reminders. The primary outcome was latency (days) from randomization to delivery. Secondary analyses included composite neonatal and maternal clinical outcomes and maternal mental health survey results. Statistical analyses were conducted with an intent-to-treat approach under a Bayesian framework using neutral priors (a priori assumed 50:50 likelihood of longer latency in either arm). A total of 100 participants were required to have 80% power to demonstrate a 4-day difference in latency with 75% certainty (Bayesian probability). RESULTS: Among 163 eligible individuals, 100 (61%) were randomized, and after loss to follow-up, 95 were analyzed. Gestational age at randomization was 29 3/7 weeks (interquartile range, 26 2/7 to 31 5/7) in the intervention arm and 27 4/7 weeks (interquartile range, 25 4/7 to 29 6/7) in the usual-care arm. Median step counts were 1690 per day in the intervention arm (interquartile range, 1031-2641) and 1338 per day in the usual-care arm (interquartile range, 784-1913). Median days of latency were 9 days in the intervention arm (interquartile range, 4-17) and 6 days in the usual-care arm (interquartile range, 2-14). The primary analysis indicated a 65% posterior probability that the intervention increased latency relative to usual care (posterior relative risk, 1.09; 95% credible interval, 0.70-1.71). The relative risk was 0.55 (95% credible interval, 0.32-0.82) for the composite neonatal adverse outcome, with 99% posterior probability of intervention benefit, and was 0.94 (95% credible interval, 0.72-1.20) for the composite maternal adverse outcome, with 70% posterior probability of intervention benefit. There was a 94% posterior probability of the intervention arm having a greater decrease in maternal stress score from baseline to before delivery compared with the usual-care arm (mean arm difference, 3.24 points [95% credible interval, -7.23 to 0.79]). Adjustment for gestational age at randomization had minimal impact on secondary outcome results. CONCLUSION: Individuals with preterm prelabor rupture of membranes randomized to encouragement to ambulate had a longer latency to delivery and improved neonatal and mental health outcomes, with similar maternal clinical outcomes compared with usual care.

Time to Completion of Two-Step Screening for Gestational Diabetes and Adverse Outcomes.

OBJECTIVE: This study aimed to ascertain whether the length of time to complete the gestational diabetes mellitus (GDM) screening was associated with adverse neonatal outcomes. STUDY DESIGN: This was a retrospective cohort study of singleton, nonanomalous individuals who were screened for GDM at ≥24 weeks' gestation at an academic hospital system. We compared outcomes among people who were diagnosed with GDM and completed the 3-hour glucose tolerance test (GTT) ≤14 second versus >14 days from the 1-hour glucose challenge test (GCT). The primary outcome was a composite adverse neonatal outcome of the following: large for gestational age, shoulder dystocia, birth injury, respiratory distress, hypoglycemia, or fetal/neonatal death. The secondary outcomes included several individual neonatal and maternal morbidities. Multivariable Poisson's regression models were used to evaluate the association. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated. RESULTS: Among the 313 individuals who completed the two-step screening for GDM and had an 1-hour GCT ≥ 135 mg/dL; of them, 171 (54.6%) completed the 3-hour GTT ≤14 days, 142 (45.4%) completed the 3-hour GTT > 14 days. Overall rate of the primary outcome was 44.1%. After multivariable adjustment, the risk of the primary outcome was similar between people who completed the two-step method in ≤14 versus >14 days (aRR = 1.11, 95% CI = 0.81-1.52). There was no significant difference in all secondary adverse outcomes between the two groups. Subgroup analyses, limited to people diagnosed with GDM (N = 89, 23.4%), also found similar results as the full analyses. CONCLUSION: Among individuals who completed the two-step screening for GDM, completion of the 3-hour GTT within ≤14 versus ≥ 14 days was not associated with an increase rate of the adverse outcomes. KEY POINTS: · Among pregnant people in an academic practice, 50% of people with abnormal 1-hour GTT completed GDM two-step screening in 14 days.. · Longer length of time to completion of diagnostic testing for GDM was not associated with an increased rate of adverse outcomes.. · Pregnant people that were diagnosed with GDM and completed the two-step method in >14 days did not have worse perinatal outcomes..

Continuous Glucose Monitoring and Time in Range: Association with Adverse Outcomes among People with Type 2 or Gestational Diabetes Mellitus.

OBJECTIVE: Continuous glucose monitoring (CGM) has become available for women with type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM) during pregnancy. The recommended time in range (TIR, blood glucose 70-140 mg/dL) and its correlation with adverse pregnancy outcomes in this group is unknown. Our aim was to compare maternal and neonatal outcomes in pregnant people with T2DM or GDM with average CGM TIR values >70 versus ≤ 70%. STUDY DESIGN: We conducted a retrospective cohort study of all individuals using CGM during pregnancy from January 2017 to June 2022. Individuals with type 1 diabetes mellitus, or those missing CGM or delivery data were excluded. Primary composite neonatal outcome included any of the following: large for gestational age, NICU admission, need for intravenous glucose, respiratory support, or neonatal death. Secondary outcomes included other maternal and neonatal outcomes. Regression models were used to estimate adjusted odds ratio (aOR) and 95% confidence interval (CI). RESULTS: During the study period, 141 individuals with diabetes utilized CGM during pregnancy, with 65 (46%) meeting inclusion criteria. Of the study population, 28 (43%) had TIR ≤70% and 37 (57%) had TIR > 70%. Compared with those with TIR > 70%, the primary composite outcome occurred more frequently in neonates of individuals TIR ≤70% (71.4 vs. 37.8%, aOR: 4.8, 95% CI: 1.6, 15.7). Furthermore, individuals with TIR ≤70% were more likely to have hypertensive disorders (42.9 vs. 16.2%, OR: 3.9, 95% CI: 1.3, 13.0), preterm delivery (54 vs. 27%, OR: 3.1, 95% CI: 1.1, 9.1): , and cesarean delivery (96.4 vs. 51.4%, OR: 4.6, 95% CI: 2.2, 15.1) compared with those with TIR >70%. CONCLUSION: Among people with T2DM or GDM who utilized CGM during pregnancy, 4 out 10 individuals had TIR ≤70% and, compared with those with TIR > 70%, they had a higher likelihood of adverse neonatal and maternal outcomes. KEY POINTS: · Time in range can be utilized as a metric for pregnant patients using continuous glucose monitor.. · Time in range >70% is achievable by 6 out of 10 patients.. · Time in range below goal is associated with adverse neonatal and maternal outcomes..

Leaving the Placenta In Situ in Placenta Accreta Spectrum Disorders: A Single-Center Case Series.

OBJECTIVE: The most common treatment for placenta accreta spectrum (PAS) disorders is planned primary cesarean hysterectomy. However, other management strategies may improve outcomes and/or allow fertility preservation. The objective of this study was to describe the course and outcomes of patients with PAS managed by leaving the placenta in situ. STUDY DESIGN: This is a series of 11 patients with PAS managed by leaving the placenta in situ at a single academic center in the United States from 2015 to 2022. The approach described involves delivery of the fetus via cesarean, no attempt at placental removal, closure of the hysterotomy, prophylactic intravenous antibiotics for up to 1 week, and close outpatient follow-up until the uterus is empty. RESULTS: The uterus was successfully preserved in six (55%), minimally invasive hysterectomy was performed in four (36%), and abdominal hysterectomy was performed in 1 (9%). During cesarean delivery, the median estimated blood loss was 650mL (range: 200-1,000mL). The majority of patients had no vaginal discharge for several weeks after delivery, followed by brown or bloody discharge, and intermittent mild-to-moderate cramping. The median time to resolution of PAS was 18 weeks in patients with successful uterine preservation (range: 5-25 weeks). Indications for hysterectomy included hemorrhage (n=1), coagulopathy (n=1), endomyometritis (n=2), and pain (n=1), and these occurred at a median of 5 weeks postpartum (range: 1-25 weeks). Four patients had subsequent pregnancies of whom three were live births at or near term and one was a spontaneous abortion at 19 weeks. CONCLUSION: Leaving the placenta in situ may be an appropriate management strategy for some carefully selected and counseled patients with PAS. KEY POINTS: · Overall, 55% had uterine preservation (6/11).. · Minimally invasive approach in 80% of hysterectomies (4/5).. · Of patients, 67% with uterine preservation had subsequent pregnancies (4/6)..

Triple Negative Breast Cancer: Updates on Classification and Treatment in 2021.

Breast cancer (BC) is the most common malignancy affecting women. It is a highly heterogeneous disease broadly defined by the differential expression of cell surface receptors. In the United States, triple negative breast cancer (TNBC) represents 15 to 20% of all BC. When compared with other subtypes of BC, TNBC tends to present in younger women, and has a higher mortality rate of 40% in advanced stages within the first 5 years after diagnosis. TNBC has historically had limited treatment options when compared to other types of BC. The mainstay of treatment for TNBC remains cytotoxic chemotherapy despite the emergence of new biologic and targeted agents. Defining the specific tumor molecular profile including PDL-1 and androgen receptor testing is expanding treatment options in the clinical setting. Identifying more targetable, novel biomarkers that may better define therapeutic targets or prognostic markers is currently underway. TNBC nomenclature is expected to be updated in favor of other nomenclature which would help direct therapy, and further redefine TNBC's heterogeneity. Given the continuous advances in the field of TNBC, this review assesses the latest developments in basic characterization, subtyping, and treatment of TNBC, including novel drug developments with antibody-drug conjugates, immune checkpoint inhibitors, PARP inhibitors and androgen receptor targeted agents. Future trials are necessary in the face of these innovations to further support the use of new therapies in TNBC and the detection of the appropriate biomarkers.