Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic test used in trauma for goal-directed transfusion. However, there are limited data on baseline ROTEM parameters in the U.S. obstetric population. Obtaining baseline parameters is a first step in implementing a goal-directed massive transfusion protocol in obstetric hemorrhage.
Background: Several meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (<34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.Methods: This randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres. Women with singleton pregnancies and 12 to 20 weeks gestation were eligible. Randomisation was generated in SAS® by site in blocks of 4. The planned adaptive design periodically generated allocation ratios favoring the better performing dose. Managing study personnel were blind to treatment until 30 days after the last birth. The primary outcome was early preterm birth by dose and by enrollment DHA status (low/high). Bayesian posterior probabilities (pp) were determined for planned efficacy and safety outcomes using intention-to-treat. Findings: Eleven hundred participants (1000 mg, n=576; 200 mg, n=524) were enrolled between June 8, 2016 and March 13, 2020. 1032 (n=540 and n=492) were included in the primary analyses. The higher dose was superior for prevention of early preterm birth [1.7% (9/540) vs 2.4% (12/492), pp=0.81]. Participants with low enrollment DHA status had half the rate of early preterm birth with 1000 compared to 200 mg [2.0% (5/249) vs 4.1%, (9/219), pp=0.93]. Participants with high enrollment DHA status did not realize a dose effect [1000 mg: 1.4% (4/289); 200 mg: 1.1% (3/271), pp=0.57]. The higher dose was associated with fewer serious adverse events (maternal: chorioamnionitis, premature rupture of membranes and pyelonephritis; neonatal: feeding, genitourinary and neurologic problems, all pp>0.90).Interpretation: Physicians should consider prescribing 1000 mg DHA daily during pregnancy to reduce early preterm birth, particularly in women entering pregnancy with low DHA status.Trial Registration: The study is registered with ClinicalTrials.gov (NCT02626299) and closed to enrollment.Funding Statement: National Institutes of Health Child Health and Human Development (NICHD) R01HD083292.Declaration of Interests: SEC has received honorariums for presentations about DHA in infancy and pregnancy. CJV is an employee of RB Nutrition, which produces infant formulas and supplements, however, RB had no involvement in the study execution or analysis. She conducted this study through her role as an Adjunct Professor at The University of Cincinnati. The other authors have no competing interests.Ethics Approval Statement: The University of Kansas Medical Center granted approval under a central IRB with reliance by the other institutions (STUDY00003455). All participants gave written consent.
Cervical cerclage remains the preferred treatment for women with cervical insufficiency, but the best technique and timing for cerclage placement remain uncertain. This retrospective cohort study compared the use of a single stitch with 2 cerclage stitches in 150 women with singleton pregnancies. There were no baseline differences between the 112 patients given 1 stitch and the 38 given 2 stitches. These were consecutive pregnancies in women having cervical cerclage placement because of either a history of cervical insufficiency (habitual immature deliveries at 16–28 weeks’ gestation) or a sonographic cervical length less than 25 mm. All cerclages were placed before 24 weeks’ gestation. Nearly one-third of participants had complications following cerclage placement, but there were no significant differences in complication rates between the 2 surgical groups. There also was no significant difference between the 2 groups in gestational age at the time of delivery, either overall or for a given gestational age cutoff such as 37 weeks’ gestation. Five women in the single-stitch group (4.5%) and none of those in the 2-stitch group experienced pregnancy loss before 20 weeks’ gestation. The only outcomes that differed significantly were a longer duration of rupture of membranes and a longer time in the labor unit in the 2-stitch group. Logistic regression analysis confirmed a lack of significant difference in the relative risk of preterm birth between the 2-stitch and single-stitch groups.
Introduction: The incidence of cardiac disease in pregnancy continues to increase, particularly pregnancy with complex congenital heart diseases. Fontan circulation is a unique circulation surgically created for individuals with single ventricle physiology, effects of which on developing placenta and fetus are not completely understood. Chronic placental hypoxia in Fontan circulation might explain increased incidence of chorioangioma in those patients.
Introduction: Pregnancy is contraindicated in women with pulmonary hypertension (PH), yet many still decide to pursue pregnancy. Hypothesis: We hypothesized improved maternal mortality with PH at our center’s cardio-obstetrics program and sought to identify factors to estimate the risk of major adverse cardiac events (MACE). Methods: Pregnant women with right ventricular systolic pressure (RVSP) ≥35 mmHg or tricuspid regurgitant velocity > 2.8 m/s on transthoracic echocardiogram (TTE) were identified. Women with intermediate to high probability PH by ESC criteria (TTE or catheterization, n = 70) were classified using the 6 th World Society of PH definitions. Results: In 70 women with PH (30 ± 6 years-old, RVSP 52 ± 16 mmHg) there were 12 (17%) with WHO Group 1 PH, 45 (64%) with Group 2 PH, 4 (6%) with Group 3 PH and 9 (13%) with Group 5 PH (Figure A). Baseline characteristics were similar except: Group 1 PH had 83% on prostacyclin (PC) therapy, higher RVSP (78 ± 20 mmHg vs. Groups 2 (46 ± 9), 3 (44 ± 2 mmHg) and 5 PH (48 ± 10mmHg), p<0.01), and compared to Group 2 PH, more Group 1 PH women were diagnosed pre-pregnancy (9 (75%) vs. 12 (27%), p = 0.01) and had cardio-obstetrics care (10 (83%) vs. 16 (36%), p < 0.01) (Figure B - E). There were no peripartum deaths, however 3 (4.3%) women with Group 2 PH had late mortality (7 ± 4 months post-partum). MACE occurred in 24 (34%) women and was more likely in those with: NYHA FC ≥ 2 (95% CI 4.7-57, p < 0.01), pre-eclampsia (95% CI 1.2-13, p = 0.03), RVSP >50 mmHg (95% CI 1.3-10, p = 0.02) and LVEF <50% (95% CI 1.1-8.8, p = 0.04) (Figure F). Preterm birth occurred in 32 (49%) pregnancies, with no neonatal mortality. Conclusion: To conclude, in a large single center cohort we report 100% 1-year survival in Groups 1, 3, and 5 PH, with most Group 1 PH patients on PC therapy and under cardio-obstetrics care. We identify Group 2 PH as an under-recognized group for adverse outcomes in pregnancy, with NYHA FC, pre-eclampsia, RVSP >50 mmHg and LVEF <50% associated with increased MACE.
Introduction: Fetal heart rate monitoring presents one of the few available methods for evaluating the fetus prior to birth. However, current devices on the market have significant shortcomings. We sought to describe the use and experiences with external fetal monitoring (EFM) devices among obstetrical providers.Materials and methods: We performed a cross-sectional survey in an academic medical center between April and July 2017 including nurse, midwife, and physician obstetrical providers (n = 217) who were invited to participate in this study regarding their experiences with the external fetal monitoring (EFM) device utilized by their hospital system in the outpatient, inpatient, and labor and delivery (L&D) settings. Associations between provider characteristics, device use, perception of challenging patients, and potential usefulness of an improved system were assessed by Fisher’s exact test.Results: The 137 respondents (63.1%) reported difficulties monitoring obese women (98.5%), multiple gestation pregnancies (90.5%), and early gestational ages (71.5%). Over half (59.5%) of L&D nurses reported interacting with EFM devices for greater than 1-hour during a typical 12-hour shift and fewer than half (42.3%) reported being satisfied with current EFM devices. There were no statistically significant associations between provider age, experience, or time spent utilizing the devices with perception of challenging patient types.Conclusions: In conclusion, obstetrical providers perceive shortcomings of current EFM devices across all levels of provider experience and time utilizing these devices. Nurses reported significant time operating the devices, representing an opportunity to reduce time and costs with an improved device.
