Real-world evidence for the utility of serum soluble fms-like tyrosine kinase 1/placental growth factor test for routine clinical evaluation of hospitalized women with hypertensive disorders of pregnancy.

BACKGROUND: An imbalance of the antiangiogenic factor, soluble fms-like tyrosine kinase-1, and proangiogenic factor, placental growth factor, in the circulation is a reliable predictor for the development of preeclampsia with severe features and related adverse outcomes. In 2023, the US Food and Drug Administration approved a serum soluble fms-like tyrosine kinase-1/placental growth factor test at a cutoff of 40 to aid in the risk assessment of women hospitalized for hypertensive disorders of pregnancy for the progression to preeclampsia with severe features between 23 and 35 weeks. OBJECTIVE: This study aimed to generate real-world evidence for clinical utility for serum soluble fms-like tyrosine kinase-1/placental growth factor test when made available to clinicians in a timely fashion as an aid in risk stratification of development of preeclampsia with severe features within 2 weeks of testing among hospitalized patients with hypertensive disorders of pregnancy. STUDY DESIGN: Hospitalized patients with hypertensive disorders of pregnancy between 23 weeks to 34 weeks and 6 days of gestation were prospectively studied from June 2023 to January 2024 after the implementation of serum soluble fms-like tyrosine kinase-1/placental growth factor testing into routine clinical practice. Serum samples were obtained from patients via venipuncture and analyzed on an automated immunoassay platform (placental growth factor and soluble fms-like tyrosine kinase-1 assays; Thermo Fisher Scientific). Before implementation, physicians were educated on appropriate use and management guidelines on the basis of biomarkers but made pragmatic management decisions independently. Results of soluble fms-like tyrosine kinase-1/placental growth factor tests were available to clinicians within 24 hours of venipuncture. The association between soluble fms-like tyrosine kinase-1/placental growth factor ≥40 and progression to preeclampsia with severe features and adverse maternal/perinatal outcomes were assessed. RESULTS: Of the 65 patient encounters, 36 had a soluble fms-like tyrosine kinase-1/placental growth factor <40 (55.4%). The rate of delivery for indications related to hypertensive disorders of pregnancy within 2 weeks was significantly lower among encounters with a low ratio vs high ratio (2/36 [5.6%] vs 21/29 [72.4%]) even after controlling for relevant confounders (adjusted hazard ratio, 7.52; 95% confidence interval, 3.05-18.54; P<.001). A diagnosis of preeclampsia with severe features within 2 weeks of testing was also less likely among the encounters with soluble fms-like tyrosine kinase-1/placental growth factor ratio <40 when compared with soluble fms-like tyrosine kinase-1/placental growth factor ratio ≥40 (2/36 [5.6%] vs 23/29 [79.3%], P<.001; positive predictive value of 79% [95% confidence interval, 0.65-0.94] and negative predictive value of 0.94 [95% confidence interval, 0.87-1.00]). The positive and negative likelihood ratios for the development of preeclampsia with severe features within 2 weeks of testing were 6.13 and 0.09, respectively. Encounters with a soluble fms-like tyrosine kinase-1/placental growth factor ratio <40 were less likely to experience a maternal or fetal adverse event as compared with encounters with soluble fms-like tyrosine kinase-1/placental growth factor ratio ≥40 (3/36 [8.3%] vs 10/29 [34.5%], P=.01). Among 36 encounters involving low soluble fms-like tyrosine kinase-1/placental growth factor values, 22 had had equivocal clinical or laboratory criteria resembling preeclampsia at presentation but were expectantly managed on the basis of biomarkers, and none developed preeclampsia with severe features or adverse outcomes at 2 weeks. The median latency defined as days between biomarker measurement and delivery in patients with a low biomarker ratio was 33 (interquartile ratio, 23-47) vs 7 (interquartile ratio, 4-14) days among patients with a high ratio (P<.001). Corticosteroid use within 2 weeks was also significantly reduced in the low biomarker group when compared with the high biomarker group (8/35 [22.9%] vs 24/29 [82.8%], P<.001). CONCLUSION: In this study, the incorporation of soluble fms-like tyrosine kinase-1/placental growth factor ratio into clinical practice serves as a dependable supplement in assessing risk for progression to preeclampsia with severe features and adverse outcomes in patients with hypertensive disorders of pregnancy in the United States. Among patients with a low ratio, pregnancy may be prolonged, which results in better neonatal outcomes without harm to the mother.

Zika Virus Disease and Pregnancy Outcomes in Colombia.

BACKGROUND: In 2015 and 2016, Colombia had a widespread outbreak of Zika virus. Data from two national population-based surveillance systems for symptomatic Zika virus disease (ZVD) and birth defects provided complementary information on the effect of the Zika virus outbreak on pregnancies and infant outcomes. METHODS: We collected national surveillance data regarding cases of pregnant women with ZVD that were reported during the period from June 2015 through July 2016. The presence of Zika virus RNA was identified in a subgroup of these women on real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Brain or eye defects in infants and fetuses and other adverse pregnancy outcomes were identified among the women who had laboratory-confirmed ZVD and for whom data were available regarding pregnancy outcomes. We compared the nationwide prevalence of brain and eye defects during the outbreak with the prevalence both before and after the outbreak period. RESULTS: Of 18,117 pregnant women with ZVD, the presence of Zika virus was confirmed in 5926 (33%) on rRT-PCR. Of the 5673 pregnancies with laboratory-confirmed ZVD for which outcomes had been reported, 93 infants or fetuses (2%) had brain or eye defects. The incidence of brain or eye defects was higher among pregnancies in which the mother had an onset of ZVD symptoms in the first trimester than in those with an onset during the second or third trimester (3% vs. 1%). A total of 172 of 5673 pregnancies (3%) resulted in pregnancy loss; after the exclusion of pregnancies affected by birth defects, 409 of 5426 (8%) resulted in preterm birth and 333 of 5426 (6%) in low birth weight. The prevalence of brain or eye defects during the outbreak was 13 per 10,000 live births, as compared with a prevalence of 8 per 10,000 live births before the outbreak and 11 per 10,000 live births after the outbreak. CONCLUSIONS: In pregnant women with laboratory-confirmed ZVD, brain or eye defects in infants or fetuses were more common during the Zika virus outbreak than during the periods immediately before and after the outbreak. The frequency of such defects was increased among women with a symptom onset early in pregnancy. (Funded by the Colombian Instituto Nacional de Salud and the Centers for Disease Control and Prevention.).

Zika Virus Disease in Colombia - Preliminary Report.

BACKGROUND: Colombia began official surveillance for Zika virus disease (ZVD) in August 2015. In October 2015, an outbreak of ZVD was declared after laboratory-confirmed disease was identified in nine patients. METHODS: Using the national population-based surveillance system, we assessed patients with clinical symptoms of ZVD from August 9, 2015, to April 2, 2016. Laboratory test results and pregnancy outcomes were evaluated for a subgroup of pregnant women. Concurrently, we investigated reports of microcephaly for evidence of congenital ZVD. RESULTS: By April 2, 2016, there were 65,726 cases of ZVD reported in Colombia, of which 2485 (4%) were confirmed by means of reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay. The overall reported incidence of ZVD among female patients was twice that in male patients. A total of 11,944 pregnant women with ZVD were reported in Colombia, with 1484 (12%) of these cases confirmed on RT-PCR assay. In a subgroup of 1850 pregnant women, more than 90% of women who were reportedly infected during the third trimester had given birth, and no infants with apparent abnormalities, including microcephaly, have been identified. A majority of the women who contracted ZVD in the first or second trimester were still pregnant at the time of this report. Among the cases of microcephaly investigated from January 2016 through April 2016, four patients had laboratory evidence of congenital ZVD; all were born to asymptomatic mothers who were not included in the ZVD surveillance system. CONCLUSIONS: Preliminary surveillance data in Colombia suggest that maternal infection with the Zika virus during the third trimester of pregnancy is not linked to structural abnormalities in the fetus. However, the monitoring of the effect of ZVD on pregnant women in Colombia is ongoing. (Funded by Colombian Instituto Nacional de Salud and the Centers for Disease Control and Prevention.).

Topical negative pressure wound therapy to prevent wound complications following caesarean delivery in high-risk obstetric patients: A randomised controlled trial.

BACKGROUND AND AIMS: We investigated whether the use of a prophylactic negative pressure wound therapy (NPWT) system in women undergoing caesarean would decrease wound complications in a high-risk population. MATERIALS AND METHODS: A randomised controlled trial was performed. Women with risk factors for wound complications undergoing caesarean delivery were randomised to a standard dressing or NPWT placed over their caesarean wound. We standardised the closure of the subcutaneous fat and skin layers, both with Vicryl. Patients were followed for wound complications for up to 6 weeks after their caesareans. The incidence of wound complications was the primary outcome. The single-use NPWT system, PICO, was provided by Smith and Nephew for use in this trial. The trial was registered on clinicaltrials.gov, # NCT03082664. RESULTS: We report here on 154 women randomised to either a standard dressing or to the NPWT. Wound complication rates were equivalent between groups, with 19.4 and 19.7% (P = 0.43) of women with follow-up information available experiencing wound complications. CONCLUSION: We found no difference in wound complications in women with risk factors treated with a prophylactic NPWT system or standard wound dressing at the time of caesarean birth.

Severity of illness by pregnancy status among laboratory-confirmed SARS-CoV-2 infections occurring in reproductive-aged women in Colombia.

BACKGROUND: Multiple studies have described increased risk of severe coronavirus disease (COVID-19) among pregnant women compared to nonpregnant women. The risk in middle-income countries where the distributions of age groups and preexisting conditions may differ is less known. OBJECTIVES: To determine whether pregnant women with SARS-CoV-2 infection are at increased risk for severe COVID-19 compared to nonpregnant women in Colombia. METHODS: We analysed national surveillance data from Colombia, of women aged 15-44 years with laboratory-confirmed infection with SARS-CoV-2 by molecular or antigen testing, from 6 March 2020 to 12 December 2020. An enhanced follow-up of pregnant women with COVID-19 was established to monitor pregnancy and birth outcomes. RESULTS: Of 371,363 women aged 15-44 years with laboratory-confirmed SARS-CoV-2 infection, 1.5% (n = 5614) were reported as pregnant; among those, 2610 (46.5%) were considered a complete pregnancy for reporting purposes at the time of analysis. Hospitalisation (23.9%) and death (1.3%) occurred more frequently among pregnant symptomatic women compared to nonpregnant symptomatic women (2.9% and 0.3%, respectively). Compared to nonpregnant symptomatic women, pregnant symptomatic women were at increased risk of hospitalisation (adjusted risk ratio [RR] 2.19, 95% confidence interval [CI] 2.07, 2.32) and death (RR 1.82, 95% CI 1.60, 2.07), after adjusting for age, type of health insurance and presence of certain underlying medical conditions. Among complete pregnancies, 55 (2.1%) were pregnancy losses, 72 (2.8%) resulted in term low birthweight infants and 375 (14.4%) were preterm deliveries. CONCLUSIONS: Although pregnant women were infrequently reported with laboratory-confirmed SARS-CoV-2 infection, pregnant symptomatic women with COVID-19 were at increased risk for hospitalisation and death compared to nonpregnant symptomatic women. Almost all infections we reported on were third-trimester infections; ongoing follow-up is needed to determine pregnancy outcomes among women infected earlier in pregnancy. Healthcare providers should counsel pregnant women about preventive measures to protect from SARS-CoV-2 infection and when to seek care.

Epidemiology of cytomegalovirus Infection among mothers and infants in Colombia.

We assessed maternal and infant cytomegalovirus (CMV) infection in Colombia. Maternal serum was tested for CMV immunoglobulin G antibodies at a median of 10 (interquartile range: 8-12) weeks gestation (n = 1501). CMV DNA polymerase chain reaction was performed on infant urine to diagnose congenital (≤21 days of life) and postnatal (>21 days) infection. Maternal CMV seroprevalence was 98.1% (95% confidence interval [CI]: 97.5%-98.8%). Congenital CMV prevalence was 8.4 (95% CI: 3.9%-18.3%; 6/711) per 1000 live births. Among 472 infants without confirmed congenital CMV infection subsequently tested at age 6 months, 258 (54.7%, 95% CI: 50.2%-59.1%) had postnatal infection.

Neurodevelopmental findings in children 20-30 months of age with postnatal Zika infection at 1-12 months of age, Colombia, September-November 2017.

BACKGROUND: Zika virus (ZIKV) infection during pregnancy can cause infant brain and eye abnormalities and has been associated with adverse neurodevelopmental outcomes in exposed infants. Evidence is limited on ZIKV's effects on children infected postnatally within the first year of life. OBJECTIVE: To determine whether any adverse neurodevelopmental outcomes occurred in early childhood for children infected postnatally with ZIKV during infancy, given the neurotoxicity of ZIKV infection and the rapid brain development that occurs in infancy and early childhood. METHODS: The Colombia Instituto Nacional de Salud (INS) conducted health and developmental screenings between September and November 2017 to evaluate 60 children at ages 20-30 months who had laboratory-confirmed symptomatic postnatal ZIKV infection at ages 1-12 months. We examined the frequency of adverse neurologic, hearing, eye, and developmental outcomes as well as the relationship between age at Zika symptom onset and developmental outcomes. RESULTS: Nine of the 60 (15.0%) children had adverse outcomes on the neurologic, hearing, or eye examination. Six of the 47 (12.8%) children without these adverse findings, and who received a valid developmental screening, had an alert score in the hearing-language domain which signals the need for additional developmental evaluation. CONCLUSION: Neurologic, hearing, eye, and developmental findings suggest reassuring results. Since the full spectrum of neurodevelopmental outcomes in children postnatally infected with ZIKV remains unknown, routine paediatric care is advised to monitor the development of these children to ensure early identification of any adverse neurodevelopmental outcomes.

UV radiation dose in real time with a cryogenic SiPM using Monte Carlo-Geant4 simulation.

At the moment, there is no method that allows the user to calculate the dose of UV radiation during the liquid nitrogen (LN2) sterilization process while complying with quality control regulations. This article describes a simulating method using Geant4 to obtain the dose of UV radiation in real-time with a cryogenic Silicon PhotoMultipliers (SiPM) inside the LN2 container. The results present the zone of minimum UV radiation and the estimation of the radiation dose with a cryogenic SiPM, located in the minimum zone to certify the absence of microorganisms in the LN2.

Performance of a Maternal Abdominal Surface Electrode System for Fetal Heart Rate and Uterine Contraction Monitoring from 34 to 37 Weeks.

OBJECTIVE: The objective of this study was to compare performance of a maternal surface electrode patch with ultrasound- and tocodynamometer-based monitoring to detect fetal heart rate and uterine contractility in late preterm labors. STUDY DESIGN: Thirty women between 340/7 and 366/7 weeks' gestation were monitored simultaneously with a Doppler/tocodynamometer system and a wireless fetal-maternal abdominal surface electrode system. Fetal and maternal heart rate and uterine contraction data from both systems were compared. Reliability was measured by the success rate and percent agreement. Deming regression and Bland-Altman analysis estimated the concordance between the systems. Uterine contractions were assessed by visual interpretation of monitor tracings. RESULTS: The success rate for the surface electrode system was 89.5% (95% confidence interval [CI], 85.7-93.3), and for ultrasound it was 88.4% (95% CI, 84.9-91.9; p = 0.73), with a percent agreement of 88.1% (95% CI, 84.2-92.8). Results were uninfluenced by the patients' body mass. The mean Deming slope was 1 and the y-intercept was -3.0 beats per minute (bpm). Bland-Altman plots also showed a close relationship between the methods, with limits of agreement less than 10 bpm. The percent agreement for maternal heart rate was 98.2% (95% CI, 97.4-98.8), and for uterine contraction detection it was 89.5% (95% CI, 85.5-93.4). CONCLUSION: Fetal heart rate and uterine contraction monitoring at 340/7 to 366/7 weeks using abdominal surface electrodes was not inferior to Doppler ultrasound/tocodynamometry for fetal-maternal assessment. REGISTRATION: clinicaltrials.gov/February 20, 2017/identifier NCT03057275. KEY POINTS: · Monitoring the preterm fetal heart rate with surface electrodes is feasible.. · Preterm contractions can be monitored with surface electrodes.. · The technique was noninferior to standard external monitors..

Zika virus detection in amniotic fluid and Zika-associated birth defects.

BACKGROUND: Zika virus infection during pregnancy can cause serious birth defects, which include brain and eye abnormalities. The clinical importance of detection of Zika virus RNA in amniotic fluid is unknown. OBJECTIVE: The purpose of this study was to describe patterns of Zika virus RNA testing of amniotic fluid relative to other clinical specimens and to examine the association between Zika virus detection in amniotic fluid and Zika-associated birth defects. Our null hypothesis was that Zika virus detection in amniotic fluid was not associated with Zika-associated birth defects. STUDY DESIGN: We conducted a retrospective cohort analysis of women with amniotic fluid specimens submitted to Colombia's National Institute of Health as part of national Zika virus surveillance from January 2016 to January 2017. Specimens (maternal serum, amniotic fluid, cord blood, umbilical cord tissue, and placental tissue) were tested for the presence of Zika virus RNA with the use of a singleplex or multiplex real-time reverse transcriptase-polymerase chain reaction assay. Birth defect information was abstracted from maternal prenatal and infant birth records and reviewed by expert clinicians. Chi-square and Fisher's exact tests were used to compare the frequency of Zika-associated birth defects (defined as brain abnormalities [with or without microcephaly, but excluding neural tube defects and their associated findings] or eye abnormalities) by frequency of detection of Zika virus RNA in amniotic fluid. RESULTS: Our analysis included 128 women with amniotic fluid specimens. Seventy-five women (58%) had prenatally collected amniotic fluid; 42 women (33%) had amniotic fluid collected at delivery, and 11 women (9%) had missing collection dates. Ninety-one women had both amniotic fluid and other clinical specimens submitted for testing, which allowed for comparison across specimen types. Of those 91 women, 68 had evidence of Zika virus infection based on detection of Zika virus RNA in ≥1 specimen. Testing of amniotic fluid that was collected prenatally or at delivery identified 39 of these Zika virus infections (57%; 15 [22%] infections were identified only in amniotic fluid), and 29 infections (43%) were identified in other specimen types and not amniotic fluid. Among women who were included in the analysis, 89 had pregnancy outcome information available, which allowed for the assessment of the presence of Zika-associated birth defects. Zika-associated birth defects were significantly (P<.05) more common among pregnancies with Zika virus RNA detected in amniotic fluid specimens collected prenatally (19/32 specimens; 59%) than for those with no laboratory evidence of Zika virus infection in any specimen (6/23 specimens; 26%), but the proportion was similar in pregnancies with only Zika virus RNA detected in specimens other than amniotic fluid (10/23 specimens; 43%). Although Zika-associated birth defects were more common among women with any Zika virus RNA detected in amniotic fluid specimens (ie, collected prenatally or at delivery; 21/43 specimens; 49%) than those with no laboratory evidence of Zika virus infection (6/23 specimens; 26%), this comparison did not reach statistical significance (P=.07). CONCLUSION: Testing of amniotic fluid provided additional evidence for maternal diagnosis of Zika virus infection. Zika-associated birth defects were more common among women with Zika virus RNA that was detected in prenatal amniotic fluid specimens than women with no laboratory evidence of Zika virus infection, but similar to women with Zika virus RNA detected in other, nonamniotic fluid specimen types.

Dengue, chikungunya and zika virus coinfection: results of the national surveillance during the zika epidemic in Colombia.

Our objective was to determine the frequency of zika (ZIKV), chikungunya (CHIKV) and dengue (DENV) virus coinfection and describe the mortality cases that occurred during the epidemiologic surveillance of the ZIKV epidemic in Colombia. We analysed all cases of suspected ZIKV infection that were reported to the National Institute of Health (October 2015-December 2016). DENV, CHIKV and ZIKV RNA were detected in serum or tissue samples using polymerase chain reaction assay. Medical records of the fatal cases were reviewed. We identified that 23 871 samples were processed. The frequency of viral agents was 439 (1.84%) for DENV, 257 (1.07%) for CHIKV and 10118 (42.38%) for ZIKV. Thirty-four (0.14%) cases of coinfection were identified. The CHIKV-ZIKV coinfection was present in 28 cases (82.3%), DENV-CHIKV in three (8.8%) and DENV-ZIKV in three (8.8%). Seven (20.6%) coinfection cases were fatal (two DENV-CHIKV cases and five CHIKV-ZIKV cases). Two cases were foetal deaths and the others were related to neurological syndrome and sepsis. In conclusion, the frequency of arbovirus coinfection during epidemic of ZIKV was low, and CHIKV-ZIKV coinfection was the most common. Mortality was high among coinfection patients. The role of each virus in the mortality cases of coinfection warrants further studies.

Misoprostol in Addition to a Double-Balloon Catheter for Induction: A Double-Blind Randomized Controlled Trial.

OBJECTIVE: This article aims to evaluate whether the use of a double-balloon catheter with oral misoprostol results in a lower rate of cesarean and shorter times to delivery than the use of the double-balloon catheter with oral placebo. STUDY DESIGN: In a double-blind randomized controlled trial, a double-balloon catheter was used for induction of labor with two doses of either 50 µg of misoprostol or placebo. Outcomes included cesarean rate, time to vaginal delivery, change in Bishop's score, and oxytocin usage. RESULTS: A total of 343 women were screened and 199 randomized: 99 to the misoprostol arm and 100 to the placebo arm. Cesarean delivery rate was not different between the groups (misoprostol: 13.1% vs. placebo: 17.0%, p = 0.45). Time to vaginal delivery was significantly shorter (mean: 14.6 ± 6.9 vs. 20.8 ± 13.8 hours, p < 0.0001), change in Bishop's score was significantly greater (median: 5 vs. 4 points, p = 0.005), and use of oxytocin was significantly less frequent (86.9 vs. 98.0% patients, p = 0.01) in the misoprostol group. CONCLUSION: The use of a double-balloon catheter with oral misoprostol for induction did not reduce the cesarean delivery rate, but did result in shorter labors, a greater increase in Bishop's score, and a lower need for oxytocin use.

Zika Virus Disease in Children in Colombia, August 2015 to May 2016.

BACKGROUND: Children are considered a potentially vulnerable population for Zika virus infection. However, data on paediatric Zika virus infection are sparse. METHODS: We analysed data from Colombia's national surveillance system during the 2015-2016 Zika virus outbreak on patients meeting the clinical case definition of Zika virus disease (ZVD) among children aged 1 month to 18 years to estimate incidence by demographic characteristics and characterize the occurrence of selected complications. RESULTS: Between August 14, 2015, and May 28, 2016, there were 18 576 reported cases of postnatal ZVD among children aged 1 month to 18 years. Laboratory testing was prioritized for high-risk patients (infants, pregnant women, adults aged ≥65 years, and persons with serious co-morbidities); among 1655 that were tested by real-time reverse transcriptase polymerase chain reaction, 1207 (72.9%) were positive. The cumulative incidence of reported ZVD was 114.4 per 100 000. The incidence differed by sex, depending on age group; the largest difference was observed for 15-18 year olds, with females having a higher incidence than males (cumulative incidence ratio 2.5, 95% confidence interval 2.3, 2.7). At the time of report to the surveillance system, 631 patients (3.4%) were hospitalised and 96 (0.5%) had a report of an accompanying neurological diagnosis, including Guillain-Barré syndrome in 40 patients. CONCLUSIONS: Only a small proportion of reported paediatric ZVD cases in Colombia were hospitalized or had reported neurological conditions following ZVD. However, the potential for some serious outcomes demonstrates the importance of preventing Zika virus infection in children.

Does Maternal Body Mass Index Have an Effect on the Accuracy of Ultrasound-Derived Estimated Birth Weight?: A Retrospective Study.

OBJECTIVES: The purpose of this study was to investigate the relationship between the maternal body mass index (BMI) and the accuracy of ultrasound-derived birth weight. METHODS: A retrospective chart review was performed on women who had an ultrasound examination between 36 and 43 weeks' gestation and had complete delivery data available through electronic medical records. The ultrasound-derived fetal weight was adjusted by 30 g per day of gestation that elapsed between the ultrasound examination and delivery to arrive at the predicted birth weight. RESULTS: A total of 403 pregnant women met inclusion criteria. Age ranged from 13-44 years (mean ± SD, 28.38 ± 5.97 years). The mean BMI was 32.62 ± 8.59 kg/m2 . Most of the women did not have diabetes (n = 300 [74.0%]). The sample was primarily white (n = 165 [40.9%]) and Hispanic (n = 147 [36.5%]). The predicted weight of neonates at delivery (3677.07 ± 540.51 g) was higher than the actual birth weight (3335.92 ± 585.46 g). Based on regression analyses, as the BMI increased, so did the predicted weight (P < .01) and weight at delivery (P < .01). The accuracy of the estimated ultrasound-derived birth weight was not predicted by the maternal BMI (P = .22). Maternal race and diabetes status were not associated with the accuracy of ultrasound in predicting birth weight. CONCLUSIONS: Both predicted and actual birth weight increased as the BMI increased. However, the BMI did not affect the accuracy of the estimated ultrasound-derived birth weight. Maternal race and diabetes status did not influence the accuracy of the ultrasound-derived predicted birth weight.

Preliminary Report of Microcephaly Potentially Associated with Zika Virus Infection During Pregnancy - Colombia, January-November 2016.

In Colombia, approximately 105,000 suspected cases of Zika virus disease (diagnosed based on clinical symptoms, regardless of laboratory confirmation) were reported during August 9, 2015-November 12, 2016, including nearly 20,000 in pregnant women (1,2). Zika virus infection during pregnancy is a known cause of microcephaly and serious congenital brain abnormalities and has been associated with other birth defects related to central nervous system damage (3). Colombia's Instituto Nacional de Salud (INS) maintains national surveillance for birth defects, including microcephaly and other central nervous system defects. This report provides preliminary information on cases of congenital microcephaly identified in Colombia during epidemiologic weeks 5-45 (January 31-November 12) in 2016. During this period, 476 cases of microcephaly were reported, compared with 110 cases reported during the same period in 2015. The temporal association between reported Zika virus infections and the occurrence of microcephaly, with the peak number of reported microcephaly cases occurring approximately 24 weeks after the peak of the Zika virus disease outbreak, provides evidence suggesting that the period of highest risk is during the first trimester of pregnancy and early in the second trimester of pregnancy. Microcephaly prevalence increased more than fourfold overall during the study period, from 2.1 per 10,000 live births in 2015 to 9.6 in 2016. Ongoing population-based birth defects surveillance is essential for monitoring the impact of Zika virus infection during pregnancy on birth defects prevalence and measuring the success in preventing Zika virus infection and its consequences, including microcephaly.

Zika virus prevention behaviors and knowledge among male partners of pregnant people and lack of condom use as a prevention behavior from the Zika en Embarazadas y Niños (ZEN) prospective cohort study, Colombia.

OBJECTIVE: Zika virus (ZIKV) infection in pregnancy can cause brain and eye abnormalities and neurodevelopmental sequelae. In the absence of medical countermeasures, behavioral interventions were recommended to prevent mosquito bites and sexual transmission of ZIKV. This report uses data from the Zika en Embarazadas y Niños (ZEN) prospective cohort study in Colombia to describe the knowledge, attitudes, and behaviors (KAB) related to ZIKV prevention in male partners compared to those of their pregnant partners at study enrollment during February 2017-2018. RESULTS: Most male partners reported wearing protective clothing such as long pants (97.6%) and long sleeves (72.8%), as well as covering ankles and feet (89.1%) to prevent ZIKV infection. When comparing the preventive behavior of condom use between male and pregnant partners, 26 pairs (10.0%) both responded that they performed the behavior. Overall, 25.1% of male partners and 18.9% of pregnant people reported any condom use during the three months before enrolling in ZEN. When comparing other preventive behaviors between male and pregnant partners, the behavior which was most frequently reported by both partners was wearing long pants (85.4%), and the least frequently reported by both partners was using condoms after finding out about a partner's pregnancy (3.4%).

Birth Outcomes Related to Prenatal Zika, Dengue, and Other Flavivirus Infections in the Zika en Embarazadas y Niños Prospective Cohort Study in Colombia.

Zika virus (ZIKV) infection in pregnancy is associated with severe abnormalities of the brain and eye and other adverse outcomes. Zika en Embarazadas y Niños was a prospective cohort study conducted in multiple Colombian cities that enrolled pregnant women in their first trimester. Specimens collected from pregnant women (n = 1,519) during February 2017-September 2018 and their infants (n = 1,080) during June 2017-March 2019 were tested for prenatal ZIKV infection by nucleic acid amplification tests or IgM antibody testing. Zika virus infection in pregnancy was present in 3.2% of pregnant women (incidence rate [IR] per 1,000 person-months = 5.9, 95% CI: 4.3-7.8). Presumptive ZIKV infection was present in 0.8% of infants (IR = 1.6, 95% CI: 0.7-2.9). Five percent of infants with prenatal ZIKV exposure or infection presented with Zika-associated abnormalities; 4.7% were small for gestational age. Understanding the risk of ZIKV infection during pregnancy and associated adverse outcomes can help inform counseling efforts.

Zika virus knowledge, attitudes and prevention behaviors among pregnant women in the ZEN cohort study, Colombia, 2017-2018.

BACKGROUND: Zika virus (ZIKV) infection during pregnancy can cause severe birth defects in the fetus and is associated with neurodevelopmental abnormalities in childhood. Our objective was to describe ZIKV knowledge and attitudes among pregnant women in Colombia while ZIKV was circulating and whether they predicted the adoption of behaviors to prevent ZIKV mosquito-borne and sexual transmission. METHODS: We used self-reported data from Zika en Embarazadas y Niños (ZEN), a cohort study of women in early pregnancy across three regions of Colombia during 2017-2018. We used Poisson regression to estimate associations between knowledge, attitudes and previous experience with mosquito-borne infection and preventative behaviors. RESULTS: Among 1519 women, knowledge of mosquito-borne transmission was high (1480; 97.8%) and 1275 (85.5%) participants were worried about ZIKV infection during pregnancy. The most common preventive behavior was wearing long pants (1355; 89.4%). Regular mosquito repellent use was uncommon (257; 17.0%). While ZIKV knowledge and attitudes were not associated with the adoption of ZIKV prevention behaviors, previous mosquito-borne infection was associated with increased condom use (prevalence ratio 1.4, 95% CI 1.1 to 1.7). CONCLUSIONS: Participants were well informed about ZIKV transmission and its health consequences. However, whether this knowledge resulted in behavior change is less certain.

Pregnancy, Birth, Infant, and Early Childhood Neurodevelopmental Outcomes among a Cohort of Women with Symptoms of Zika Virus Disease during Pregnancy in Three Surveillance Sites, Project Vigilancia de Embarazadas con Zika (VEZ), Colombia, 2016-2018.

Project Vigilancia de Embarazadas con Zika (VEZ), an intensified surveillance of pregnant women with symptoms of the Zika virus disease (ZVD) in Colombia, aimed to evaluate the relationship between symptoms of ZVD during pregnancy and adverse pregnancy, birth, and infant outcomes and early childhood neurodevelopmental outcomes. During May-November 2016, pregnant women in three Colombian cities who were reported with symptoms of ZVD to the national surveillance system, or with symptoms of ZVD visiting participating clinics, were enrolled in Project VEZ. Data from maternal and pediatric (up to two years of age) medical records were abstracted. Available maternal specimens were tested for the presence of the Zika virus ribonucleic acid and/or anti-Zika virus immunoglobulin antibodies. Of 1213 enrolled pregnant women with symptoms of ZVD, 1180 had a known pregnancy outcome. Results of the Zika virus laboratory testing were available for 569 (48.2%) pregnancies with a known pregnancy outcome though testing timing varied and was often distal to the timing of symptoms; 254 (21.5% of the whole cohort; 44.6% of those with testing results) were confirmed or presumptive positive for the Zika virus infection. Of pregnancies with a known outcome, 50 (4.2%) fetuses/infants had Zika-associated brain or eye defects, which included microcephaly at birth. Early childhood adverse neurodevelopmental outcomes were more common among those with Zika-associated birth defects than among those without and more common among those with laboratory evidence of a Zika virus infection compared with the full cohort. The proportion of fetuses/infants with any Zika-associated brain or eye defect was consistent with the proportion seen in other studies. Enhancements to Colombia's existing national surveillance enabled the assessment of adverse outcomes associated with ZVD in pregnancy.

Cell-Free DNA as an Addition to Ultrasound for Screening of a Complete Hydatidiform Mole and Coexisting Normal Fetus Pregnancy: A Case Report.

Background Complete hydatidiform mole and coexisting normal fetus pregnancies (CHMCF) are rare and can be life-threatening to the mother. Definitive diagnosis can be made with chorionic villus sampling or amniocentesis. However invasive procedures carry a risk of bleeding. We present the case of a twin molar pregnancy where a cell-free DNA screening test was utilized to evaluate for CHMCF pregnancy. Case A patient presented at 15-week gestational age with suspected CHMCF pregnancy. Ultrasound revealed a normal-appearing pregnancy abutting a multicystic lesion concerning for a complete mole. Cell-free DNA was obtained and was suggestive of complete paternal uniparental disomy. Pathological evaluation of the products of conception confirmed the diagnosis of CHMCF. Conclusion In atypical cases, cell-free DNA may be useful in evaluation of molar pregnancy.