Development and validation of a spontaneous preterm delivery predictor in asymptomatic women.

BACKGROUND: Preterm delivery remains the leading cause of perinatal mortality. Risk factors and biomarkers have traditionally failed to identify the majority of preterm deliveries. OBJECTIVE: To develop and validate a mass spectrometry-based serum test to predict spontaneous preterm delivery in asymptomatic pregnant women. STUDY DESIGN: A total of 5501 pregnant women were enrolled between 17(0/7) and 28(6/7) weeks gestational age in the prospective Proteomic Assessment of Preterm Risk study at 11 sites in the United States between 2011 and 2013. Maternal blood was collected at enrollment and outcomes collected following delivery. Maternal serum was processed by a proteomic workflow, and proteins were quantified by multiple reaction monitoring mass spectrometry. The discovery and verification process identified 2 serum proteins, insulin-like growth factor-binding protein 4 (IBP4) and sex hormone-binding globulin (SHBG), as predictors of spontaneous preterm delivery. We evaluated a predictor using the log ratio of the measures of IBP4 and SHBG (IBP4/SHBG) in a clinical validation study to classify spontaneous preterm delivery cases (<37(0/7) weeks gestational age) in a nested case-control cohort different from subjects used in discovery and verification. Strict blinding and independent statistical analyses were employed. RESULTS: The predictor had an area under the receiver operating characteristic curve value of 0.75 and sensitivity and specificity of 0.75 and 0.74, respectively. The IBP4/SHBG predictor at this sensitivity and specificity had an odds ratio of 5.04 for spontaneous preterm delivery. Accuracy of the IBP4/SHBG predictor increased using earlier case-vs-control gestational age cutoffs (eg, <35(0/7) vs ≥35(0/7) weeks gestational age). Importantly, higher-risk subjects defined by the IBP4/SHBG predictor score generally gave birth earlier than lower-risk subjects. CONCLUSION: A serum-based molecular predictor identifies asymptomatic pregnant women at risk of spontaneous preterm delivery, which may provide utility in identifying women at risk at an early stage of pregnancy to allow for clinical intervention. This early detection would guide enhanced levels of care and accelerate development of clinical strategies to prevent preterm delivery.

An exploratory analysis of the utility of adding cardiorespiratory biofeedback in the standard care of pregnancy-induced hypertension.

This study examined the efficacy of a cardiorespiratory biofeedback intervention compared to bed rest in the treatment of 47 women diagnosed with pregnancy-induced hypertension (PIH). The investigation consisted of a historical control group with 31 PIH subjects receiving treatment as usual (TAU), bed rest and antihypertensive medications, and an experimental group with 16 PIH subjects receiving TAU and instruction on using a portable respiratory sinus arrhythmia (RSA) biofeedback device once daily until delivery. Results indicated that systolic and diastolic blood pressure levels were unchanged for either group. Failing to find the intended main effects, a series of exploratory analyses were performed. Findings of associated hypotheses revealed that the RSA BF group had a 35 % higher birth weight than the TAU group. The gestational age at delivery was 10 % greater in the RSA BF group than in the TAU group. A significant relationship was found between the StressEraser Total and the 1-min Apgar score. Eighty-one percent of the subjects stated that the device was relaxing. Fifty percent of the subjects believed that the device helped them fall asleep. Overall, these results suggest that portable RSA biofeedback may be effective in reducing stress during pregnancy and improving perinatal outcomes.

Nonstress testing at ≤ 32.0 weeks' gestation: a randomized trial comparing different assessment criteria.

OBJECTIVE: Comparison of time and outcomes of National Institutes of Child Health and Human Development defined fetal heart rate acceleration criteria at ≤ 32 weeks (≥ 10 beats/min, ≥ 10 seconds) compared with standard criteria (≥ 15 beats/min, ≥ 15 seconds). STUDY DESIGN: Singleton high-risk pregnancies that were referred for nonstress testing at ≤ 32 weeks' gestation were randomly assigned to 15 × 15 or 10 × 10 criteria. Data included nonstress test information, maternal data, and outcomes. RESULTS: One hundred forty-three women were randomly assigned to 15 × 15 (n = 71) or 10 × 10 (n = 72). The groups were similar in maternal and pregnancy characteristics. Median time to reactive nonstress testing was shorter in the 10 × 10 group (37.3 minutes) than the 15 × 15 group (41.3 minutes; P = .04). There were no serious adverse events. CONCLUSION: The time to attain a reactive nonstress testing at ≤ 32 weeks' gestation was 4 minutes shorter when the 10 × 10 criteria were used. There were no adverse events related to use of 10 × 10 nonstress testing criteria.

AmniSure placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes.

The purpose of this study was to compare the AmniSure rapid immunoassay with standard methods for diagnosing rupture of fetal membranes. Patients presenting with signs/symptoms of membrane rupture between 15 and 42 weeks of gestation were invited to participate. Standard/control methods were performed to establish a diagnosis and compare it with AmniSure results. AmniSure performance metrics and their 95% confidence intervals were calculated. A total of 203 patients agreed to participate. Discrepancies between the control method and AmniSure were noted in seven cases. In these cases, true positives and negatives were determined by retesting with the control method and AmniSure and by noting sonographic evidence of low amniotic fluid. In the final analysis, the AmniSure diagnostic test demonstrated a sensitivity of 98.9%, specificity of 100%, positive predictive value of 100%, and a negative predictive value of 99.1%. AmniSure is highly accurate in diagnosing fetal membrane rupture.