Mid-trimester uterine electromyography in patients with a short cervix.

BACKGROUND: Preterm birth is the largest single cause of infant death in the United States. A cervical length of <2.5 cm, measured in the mid-trimester, has been shown to identify individuals at increased risk. Uterine electromyography is an emerging technology for noninvasively assessing uterine bioelectrical activity. With its ability to characterize nuanced differences in myometrial signals, uterine electromyography assessments during the mid-trimester may provide insight into the mechanisms of cervical shortening. OBJECTIVE: This study aimed to characterize uterine bioelectrical activity in pregnant individuals with short cervices in the mid-trimester compared with that of pregnant individuals of the same gestational age with normal cervical lengths. STUDY DESIGN: This is a prospective cohort study of subjects with singleton, nonanomalous pregnancies between 16 weeks and 0 days and 22 weeks and 6 days of gestational age. Subjects with normal cervical length (≥3.0 cm) were compared with subjects with short cervical length (<2.5 cm). The short-cervical-length cohort was further stratified by history of preterm birth. Multichannel uterine electromyography recordings were obtained for ∼60 minutes using proprietary, directional electromyography sensors on the abdomen. Uterine electromyography signals were observed and classified in groups as spikes, short bursts, and bursts. Primary outcomes were relative expression of spike, short-burst, and burst uterine electromyography signals. Subgroup analyses assessed each signal percentage by cervical length, history of preterm birth, and gestational age at delivery. Differences in percentage of uterine electromyography signals according to cervical length were analyzed using nonparametric tests of significance. RESULTS: Of the 28 included subjects, 10 had normal and 18 had short cervical length. There were 9 subjects with short cervical length and a history of preterm birth. Spikes were the most commonly recorded signals and were higher in the normal-cervical-length cohort (96.3% [interquartile range, 93.1%-100.0%]) than the short-cervical-length cohort (75.2% [interquartile range, 66.7%-92.0%], P=.001). In contrast, median percentages of short-bursts and bursts were significantly higher in subjects with a short cervical length (17.3% [interquartile range, 13.6%-23.9%] vs 2.5% for normal cervical length [interquartile range, 0%-5.5%], P=.001 and 6.6% [interquartile range, 0%-13.4%] vs 0% for normal cervical length [interquartile range, 0%-2.8%], P=.014, respectively). Within subgroup analyses, cervical length was inversely proportional to percentage of observed short-bursts (P=.013) and bursts (P=.014). Subjects with short cervical length and history of preterm birth had higher burst percentages (12.8% [interquartile range, 9.0%-15.7%]) than those with short cervical length and no history of preterm birth (3.3% [interquartile range, 0%-5.0%], P=.003). CONCLUSION: Short-burst and burst uterine electromyography signals are observed more frequently in mid-trimester patients with short cervical lengths. This relationship provides insight into abnormal myometrial activation in the mid-trimester and offers a plausible biophysiological link to cervical shortening.

Second trimester uterocervical angle and spontaneous preterm birth in twins.

Objective: To determine if there is an association between uterocervical angle (UCA) and spontaneous preterm birth (sPTB) < 37 weeks for women with twins.Materials and methods: Retrospective cohort study from 2014 to 2017 of twin pregnancies with cervical length (CL) screening between 15 0/7 and 24 6/7 weeks. Monochorionic-monoamniotic twins were excluded. Post-hoc UCA measurements were analyzed as a continuous variable and a wide UCA was also defined as an angle >95° and >110°. The primary outcome was sPTB < 37 weeks. Secondary outcomes were sPTB <34 weeks, <32 weeks, CL, and performance metrics for UCA. Binary logistic regression controlled for age, tobacco use, prior sPTB, CL, and gestational age at CL measurement.Results: A total of 114 women were studied. The rate of sPTB <37 weeks was 35.0%, <34 weeks was 21.4%, and <32 weeks was 17.1%. As a continuous variable, mean UCA was 117.9° (SD 27.1°) for delivery ≥37 weeks and 133.1° (SD 23.1°) <37 weeks (p = .002). A wider mean UCA was also associated with sPTB <34 weeks (sPTB ≥34 weeks: 120.9° [SD 26.5°] vs. <34 weeks: 133.0° [SD 22.8°], p = .025) and sPTB <32 weeks (sPTB ≥32 weeks: 121.2° [SD 25.9°] vs. <32 weeks: 135.0° [SD 24.0°], p = .018). However, after controlling for age, prior sPTB, tobacco use, CL measurement, and gestational age at CL measurement, UCA was not associated with sPTB <37 weeks, <34 weeks, or <32 weeks. UCA >110° was associated with sPTB <37 weeks after controlling for confounders (aOR 3.6 [95% CI 1.2-10.5], p = 0.02). There was no association between UCA >110° and sPTB <34 or <32 weeks. Furthermore, a UCA >95° was not associated with sPTB <37, <34, or <32 weeks. As a screening tool for sPTB <37 weeks, a UCA of >110° had a sensitivity of 85.7%, specificity of 43.1%, positive predictive value of 53.2%, negative predictive value of 80.0%, positive likelihood ratio of 1.5, and negative likelihood ratio of 0.3.Conclusions: In a cohort of dichorionic-diamniotic and monochroionic-diamniotic twins, UCA >110° was associated with sPTB <37 weeks. However, second trimester UCA had a low positive likelihood ratio and was not a robust marker for the prediction of sPTB in twins.

Cost and cost effectiveness of vaginal progesterone gel in reducing preterm birth: an economic analysis of the PREGNANT trial.

BACKGROUND: Preterm birth (PTB) is a costly public health problem in the USA. The PREGNANT trial tested the efficacy of vaginal progesterone (VP) 8 % gel in reducing the likelihood of PTB among women with a short cervix. OBJECTIVE: We calculated the costs and cost effectiveness of VP gel versus placebo using decision analytic models informed by PREGNANT patient-level data. METHODS: PREGNANT enrolled 459 pregnant women with a cervical length of 10-20 mm and randomized them to either VP 8 % gel or placebo. We used a cost model to estimate the total cost of treatment per mother and a cost-effectiveness model to estimate the cost per PTB averted with VP gel versus placebo. Patient-level trial data informed model inputs and included PTB rates in low- and high-risk women in each study group at <28 weeks gestation, 28-31, 32-36, and ≥37 weeks. Cost assumptions were based on 2010 US healthcare services reimbursements. The cost model was validated against patient-level data. Sensitivity analyses were used to test the robustness of the cost-effectiveness model. RESULTS: The estimated cost per mother was $US23,079 for VP gel and $US36,436 for placebo. The cost-effectiveness model showed savings of $US24,071 per PTB averted with VP gel. VP gel realized cost savings and cost effectiveness in 79 % of simulations. CONCLUSION: Based on findings from PREGNANT, VP gel was associated with cost savings and cost effectiveness compared with placebo. Future trials designed to include cost metrics are needed to better understand the value of VP.

The Polish National Registry for Fetal Cardiac Pathology: organization, diagnoses, management, educational aspects and telemedicine endeavors.

OBJECTIVE: We describe the National Registry for Fetal Cardiac Pathology, a program under the Polish Ministry of Health aimed at improving the prenatal diagnosis, care, and management of congenital heart disease (CHD). METHODS: An online database was created to prospectively record diagnosis, prenatal care, delivery, follow-up, and still images and video for fetuses with CHD. A certification program in fetal cardiac ultrasound was also implemented. Optimal screening and referral centers were identified by number of fetuses entered in the Registry yearly by each center. RESULTS: From 2004 to 2009, 2910 fetuses with CHD were registered (2473 structural, 437 functional anomalies). The most common reasons for referral for fetal echocardiography were abnormal four-chamber view (56.0%) and extra-cardiac anomalies (8.2% ), while the most common diagnoses were atrioventricular septal defects (10.2%) and hypoplastic left heart syndrome (9.7%). Prenatal diagnosis increased yearly, from 10.0% of neonatal diagnoses in 2003 to 38.0% in 2008. CONCLUSION: From inception of the registry up to 2009 there has been a fourfold increase in the number of neonates referred for cardiac surgery in whom the condition was prenatally diagnosed. Equally important achievements include the establishment of a certification program for fetal echocardiography and the organization of prenatal and neonatal management.

Predicting length of treatment for neonatal abstinence syndrome in methadone-exposed neonates.

OBJECTIVE: The objective of the study was to identify maternal variables predicting length of treatment for neonatal abstinence syndrome (NAS). STUDY DESIGN: This was a retrospective cohort study of infants treated for NAS during 2000-2006 whose mothers were on methadone maintenance at delivery. Mixed-effects linear regression was used to examine the interaction of maternal and neonatal variables with length of treatment. RESULTS: Of 204 neonates born to methadone exposed mothers, the average dose at delivery was 127 mg daily (25-340 mg) with median length of treatment 32 days (1-122 days). Trimester of initial exposure (P = .33), methadone dose at delivery (P = .198), body mass index (P = .31), antidepressant use (P = .40), cigarette use (P = .76), race (P = .78), and maternal age (P = .84) did not predict length of treatment. In the multivariate analysis, gestational age at delivery and benzodiazepine use were significant predictors of length of treatment. CONCLUSION: Later gestational age and concomitant benzodiazepine use were associated with longer treatment.