Betrand Obi Nwosu

Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings

To determine accuracy and costs of placental α‐microglobulin‐1 (PAMG‐1) test compared to standard clinical assessment (SCA) for diagnosing rupture of membranes (ROM).

Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor

Abstract Purpose: To determine values of combinations of interleukin-6 (IL-6)/cervical native insulin-like growth factor-binding protein-1 (IGFBP-1)/total IGFBP-1 (Premaquick©) in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in women with threatened preterm labor. Methods: Women with singleton pregnancies between gestation age (GA) of 24 weeks and 36 weeks and 6 days with preterm labor were recruited during a prospective multicenter study. Premaquick© was positive when at least two of three biomarkers were positive. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were estimated for both prediction of spontaneous deliveries and spontaneous exclusive preterm deliveries. Results: Ninety-seven (99.0%) out of 98 women enrolled were analyzed. Based on delivery status 7/14 days post-enrollment of general study population, Premaquick© had a sensitivity of 87.1/85.7%, a specificity of 92.4/96.8%, a PPV of 84.4/93.8% and a NPV of 93.9/92.3% for prediction of spontaneous delivery. Predictive accuracy of Premaquick© test in relation to days of enrollment were: 90.7% (≤7 days) and 92.8% (≤14 days). For women enrolled at GA <35 weeks, Premaquick© had a sensitivity of 100.0/87.5%, a specificity of 94.1/96.9%, a PPV of 70.5/87.5%, a NPV of 100.0/96.9% and an accuracy of 95.0/95.0% for prediction of preterm delivery within 7/14 days of enrollment, respectively. PPV was most significantly different in both groups when outcomes were compared between 2 days and 14 days post-enrollment (P<0.001). Conclusion: This novel triple biomarker model of native and total IGFBP-1 and IL-6 appears to be an accurate test in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in threatened preterm labor in singleton pregnancies.

Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes

Abstract Purpose: To determine the diagnostic accuracy of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) compared with traditional clinical assessment (TCA) of nitrazine, ferning and pooling for the diagnosis of prelabor rupture of membranes (PROM). Methods: A double-blinded, multicenter clinical study was conducted between February 2015 and August 2015 among pregnant women presenting with symptoms or features suggestive of PROM between 24 and 42 weeks gestation. Confirmation of PROM was done after delivery based on the presence of any two of these criteria: delivery within 48 h to 7 days, evidence of chorioamnionitis, membranes explicitly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Sensitivity, specificity and accuracy were outcome measures assessed. Results: Two hundred and thirty-six women were recruited. Three women were excluded from the final analysis due to lack of follow-up data and failure to meet inclusion criteria. Two hundred and thirty-three women had complete data for analysis. The specificity and sensitivity values for TCA were 76.2% and 85.2%, which were lower than those of Amnioquick duo+, which were 97.6% and 97.9%, respectively. The accuracy of Amnioquick duo+ was statistically higher (97.9% vs. 83.7%; RR=1.17; 95%CI=1.10–1.24; P<0.001). In equivocal cases (pooling=negative), the accuracy of Amnioquick duo+ vs. TCA was 98.4% vs. 69.4% (RR=1.42; 95%CI=1.20–1.68; P<0.001) at ≥34 weeks gestation and 100.0% vs. 71.4% (RR=1.40; 95%CI=1.07–1.83; P=0.021) at <34 weeks gestation. Conclusion: The performance matrix of Amnioquick duo+® was superior to that of TCA for diagnosing PROM even in equivocal cases.

Accuracy and response time of dual biomarker model of insulin‐like growth factor binding protein‐1/ alpha fetoprotein (Amnioquick duo+) in comparison to placental alpha‐microglobulin‐1 test in diagnosis of premature rupture of membranes

The aim of this study was to determine accuracy and response time of duo of insulin‐like growth factor binding protein‐1 (IGFBP‐1)/alpha‐fetoprotein (Amnioquick duo+) versus placental alpha‐microglobulin‐1 (PAMG‐1) in diagnosing premature rupture of membranes (PROM).

Is routine antenatal venereal disease research laboratory test still justified? Nigerian experience

Objective To determine the seroreactivity of pregnant women to syphilis in order to justify the need for routine antenatal syphilis screening. Methods A multicenter retrospective analysis of routine antenatal venereal disease research laboratory (VDRL) test results between 1 September 2010 and 31 August 2012 at three specialist care hospitals in south-east Nigeria was done. A reactive VDRL result is subjected for confirmation using Treponema pallidum hemagglutination assay test. Analysis was by Epi Info 2008 version 3.5.1 and Stata/IC version 10. Results Adequate records were available regarding 2,156 patients and were thus reviewed. The mean age of the women was 27.4 years (±3.34), and mean gestational age was 26.4 weeks (±6.36). Only 15 cases (0.70%) were seropositive to VDRL. Confirmatory T. pallidum hemagglutination assay was positive in 4 of the 15 cases, giving an overall prevalence of 0.19% and a false-positive rate of 73.3%. There was no significant difference in the prevalence of syphilis in relation to maternal age and parity (P>0.05). Conclusion While the prevalence of syphilis is extremely low in the antenatal care population at the three specialist care hospitals in south-east Nigeria, false-positive rate is high and prevalence did not significantly vary with maternal age or parity. Because syphilis is still a serious but preventable and curable disease, screening with VDRL alone, without confirmatory tests may not be justified. Because of the increase in the demand for evidence-based medicine and litigation encountered in medical practice, we may advocate that confirmatory test for syphilis is introduced in routine antenatal testing to reduce the problem of false positives. The government should increase the health budget that will include free routine antenatal testing including the T. pallidum hemagglutination assay.

A Water Leak Hang Test on a Random Sample of Condoms in Nnewi, South-East Nigeria

Background: Over the years, there has been frequent concern on the use of male latex condoms because of its dual functions of preventing unintended pregnancy and sexually transmitted infections in the society. However, their use is limited in part by questions about their performance which may be influenced by many factors including its production qualities. In Nigeria, all condoms in use are imported and as such greater effort needs to be applied in quality assurance of the numerous sources. Objectives: To estimate the rate of condom leakage among the available male latex condoms in Nigerian market and compare it with results published from other countries. Methods: A water leak hang test on a random sample of available brands of male latex condom in Nigerian health shops was done. Six commonly available male latex condoms were selected and labeled A I AII B C D & E. Fifty (50mls) of water was instilled into the unused condom and sequentially hung up for gravity effect. The primary outcome measure was the leakage of water in the condom within 2 minutes. Analysis was done using Epi-info 2008 version 5.3.1. Results: A total of 495 male latex condoms were used in the trial. All the condoms are expected to expire in at least 24 months. Of this number, 25 condoms leaked water, giving the estimated condom leakage rate of 5.05% in Nnewi South-East Nigeria. Conclusion: The leakage rate for male latex condom was very high in Nnewi, Nigeria based on this estimate. This poses a reproductive/public health concern with respect to prevention of unintended pregnancy and other preventable Sexually Transmitted Infections (STIs). Condom studies are therefore a high priority in Nigeria given the HIV/AIDs, hepatitis and sexually transmitted disease high prevalence.