Actim Partus Research Articles

Cervical Length as a Predictor of Success of Induction of Labor

Background: Vaginal delivery is the most important event occurring in women’s life. It carries many risks of significant concerns to the physicians. Predicting the chances of vaginal delivery is of paramount concern for the pregnant woman. Antenatal cervical length measurement has paramount importance in the prediction of labor. Objective: This study aimed to study the role of cervical length in prediction of success of induction of labor in term pregnancy. Patients and Methods: A prospective study where 140 pregnant women undergoing induction of labor for various indications were included, the cases were recruited from Obstetric Department of Shebin El-Kom Teaching Hospital in the period from October 2019 to December 2020. Results: Methods of induction was misoprostol in (75) females and amniotomy with oxytocin in (65) females. 97 Females were delivered by simple vaginal delivery, 79 females were delivered within 24 hours of induction, 18 females were delivered after 24 hours, and 43 females were delivered by caesarian section (C.S.). Indications of C.S. were mainly due to failed induction and fetal distress. Conclusions: We concluded that successful induction of labor was correlated significantly with detection of insulin-like growth factor-binding protein 1 (iGFBP-1) in cervical secretions and measurement of cervical length by transvaginal ultrasound (TVUS), IGFBP-1 detection by Actim Partus test is simple, easy bed side test that can predict successful induction of labor and measurement of cervical length by TVUS is a good predictor factor for successful induction of labor.

Three biomarker tests to help diagnose preterm labour: a systematic review and economic evaluation.

Preterm birth may result in short- and long-term health problems for the child. Accurate diagnoses of preterm births could prevent unnecessary (or ensure appropriate) admissions into hospitals or transfers to specialist units. The purpose of this report is to assess the test accuracy, clinical effectiveness and cost-effectiveness of the diagnostic tests PartoSure™ (Parsagen Diagnostics Inc., Boston, MA, USA), Actim® Partus (Medix Biochemica, Espoo, Finland) and the Rapid Fetal Fibronectin (fFN)® 10Q Cassette Kit (Hologic, Inc., Marlborough, MA, USA) at thresholds ≠50 ng/ml [quantitative fFN (qfFN)] for women presenting with signs and symptoms of preterm labour relative to fFN at 50 ng/ml. Systematic reviews of the published literature were conducted for diagnostic test accuracy (DTA) studies of PartoSure, Actim Partus and qfFN for predicting preterm birth, the clinical effectiveness following treatment decisions informed by test results and economic evaluations of the tests. A model-based economic evaluation was also conducted to extrapolate long-term outcomes from the results of the diagnostic tests. The model followed the structure of the model that informed the 2015 National Institute for Health and Care Excellence guidelines on preterm labour diagnosis and treatment, but with antenatal steroids use, as opposed to tocolysis, driving health outcomes. Twenty studies were identified evaluating DTA against the reference standard of delivery within 7 days and seven studies were identified evaluating DTA against the reference standard of delivery within 48 hours. Two studies assessed two of the index tests within the same population. One study demonstrated that depending on the threshold used, qfFN was more or less accurate than Actim Partus, whereas the other indicated little difference between PartoSure and Actim Partus. No study assessing qfFN and PartoSure in the same population was identified. The test accuracy results from the other included studies revealed a high level of uncertainty, primarily attributable to substantial methodological, clinical and statistical heterogeneity between studies. No study compared all three tests simultaneously. No clinical effectiveness studies evaluating any of the three biomarker tests were identified. One partial economic evaluation was identified for predicting preterm birth. It assessed the number needed to treat to prevent a respiratory distress syndrome case with a 'treat-all' strategy, relative to testing with qualitative fFN. Because of the lack of data, our de novo model involved the assumption that management of pregnant women fully adhered to the results of the tests. In the base-case analysis for a woman at 30 weeks' gestation, Actim Partus had lower health-care costs and fewer quality-adjusted life-years (QALYs) than qfFN at 50 ng/ml, reducing costs at a rate of £56,030 per QALY lost compared with qfFN at 50 ng/ml. PartoSure is less costly than Actim Partus while being equally effective, but this is based on diagnostic accuracy data from a small study. Treatment with qfFN at 200 ng/ml and 500 ng/ml resulted in lower cost savings per QALY lost relative to fFN at 50 ng/ml than treatment with Actim Partus. In contrast, qfFN at 10 ng/ml increased QALYs, by 0.002, and had a cost per QALY gained of £140,267 relative to fFN at 50 ng/ml. Similar qualitative results were obtained for women presenting at different gestational ages. There is a high degree of uncertainty surrounding the test accuracy and cost-effectiveness results. We are aware of four ongoing UK trials, two of which plan to enrol > 1000 participants. The results of these trials may significantly alter the findings presented here. The study is registered as PROSPERO CRD42017072696. The National Institute for Health Research Health Technology Assessment programme.

Diagnostic Accuracy of PremaQuick versus Actim Partus in Prediction of Preterm Labor in Symptomatic Women within 14 Days

Background: Preterm labor (PTL) remains a major source of neonatal morbidity, and mortality. Currently the trans-vaginal cervical length (TVCL), and/or cervico-vaginal fetal fibronectin (fFN) are the common diagnostic tools used for prediction of PTL. Consequently, many women and their fetuses are exposed unnecessarily tocolysis and hospital admission. Objectives: This study was designed to compare the diagnostic accuracy of PremaQuick versus Actim Partus in prediction of PTL in symptomatic women within 14 days. Patients and Methods: Two-hundred and twenty women (220) were included in this comparative prospective study and classified into two groups: 110 women with threatened preterm labor (TPTL) in the study group, and 110 controls (no TPTL). Women included in the study were subjected to: through history, collection of the cervico-vaginal fluid (CVF) samples for assessment by PremaQuick and Actim Partus tests, followed by trans-vaginal cervical length (TVCL) assessment. Studied women managed according to the hospitals protocol, with follow-up weekly in the obstetrics outpatients’ clinic after discharge from the hospital until delivery. The main outcome measures the diagnostic accuracy of PremaQuick versus Actim Partus in prediction of PTL in symptomatic women within 14 days of admission. Results: PremaQuick test was significantly more specific with higher positive predictive value (PPV) in prediction of PTL in symptomatic women within 14 days (95.5% and 89.6%; respectively) compared to CL < 25 mm (56.3% and 54.6%; respectively), (P = 0.02 and 0.03; respectively). In addition, PremaQuick test was significantly more sensitive with higher positive predictive value (PPV) in prediction of PTL in symptomatic women within 14 days (39.8% and 89.6%; respectively) compared to Actim Partus (13.9% and 55.5%; respectively), (P = 0.001 and 0.01; respectively). The Odds ratio and the relative risk for prediction of PTL in symptomatic women within 14 days were significantly high for PremaQuick compared to the CL < 25 mm, and Actim Partus. Conclusion: PremaQuick test seems to be the best complementary test to the CL < 25 in prediction of PTL in symptomatic women within 14 days. PremaQuick test compensates the low specificity and low PPV of the CL < 25 mm in prediction of PTL.

OP136 Full Texts Versus Conference Abstract Data: How Does The Message Change?

Introduction:High quality evidence for test accuracy can be scarce. We assessed the test accuracy of two tests (Actim Partus and PartoSure) for the prediction of preterm birth. Twenty published full-text papers were included whilst conference abstracts were excluded. Since systematic reviews of diagnostic tests on other topics may need to rely on data from conference abstracts, we test whether the findings of our review would change with conference abstracts included.Methods:Conference citations previously excluded (n=108) were re-screened for inclusion using the following criteria: i) the diagnostic test was Actim Partus or PartoSure ii) test accuracy data of preterm delivery within seven days was reported iii) the population was women with signs/symptoms of preterm labor with intact membranes. Relevant test accuracy data were extracted and used to calculate sensitivity and specificity. Pooled sensitivity and specificity for each test were run using data from full-text papers and conference abstracts combined. These values were compared with the pooled sensitivities and specificities produced for the systematic review using full-text papers only.Results:Preliminary pooled sensitivities of the sixteen full-text Actim Partus studies and sixteen full-texts and two abstracts were 0.77 (95% confidence interval (CI) 0.68, 0.83) and 0.76 (95% CI 0.69, 0.83) respectively whilst pooled specificities were 0.81 (95% CI 0.76, 0.85).and 0.80 (95% CI 0.75, 0.84) respectively. Preliminary, pooled sensitivities of the four full-text PartoSure studies and four full-texts and three abstracts were 0.83 (95% CI 0.61, 0.94) and 0.82 (95% CI 0.65, 0.92), respectively, whilst pooled specificities were 0.95 (95% CI 0.89, 0.98) and 0.96 (95% CI 0.94, 0.97), respectively.Conclusions:Our findings suggest that the test accuracy results would not alter substantially with the inclusion of conference abstracts. However, work is ongoing to investigate how the assessment of heterogeneity and risk of bias across studies would alter given the difficulties associated with limited methodological reporting from conference abstracts.

The Role of PTB Clinics: A Review of the Screening Methods, Interventions and Evidence for Preterm Birth Surveillance Clinics for High-Risk Asymptomatic Women

Context: Preterm birth accounts for significant neonatal mortality and morbidity as well as substantial health costs. As our understanding of aetiology and risk factors for preterm birth increases, predictive tools and prophylactic interventions have been developed to improve maternal and fetal outcomes. These are effective, but require surveillance of asymptomatic high-risk women, as well as ultrasound and surgical expertise. This has led to the development of preterm birth surveillance clinics (PSCs), which pool these resources together and have changed the focus of care from reactive to predictive and preventative management. Methods: A literature review of the evidence surrounding the predictive tests (cervical length, fetal fibronectin, Actim Partus, Partosure) and prophylactic interventions (cerclage, progesterone, Arabin pessary, antibiotics, and steroids) for preterm birth to understand what preterm birth surveillance clinics do and how effective they are. Results: Measuring cervical length and fetal fibronectin levels are two of the most accurate predictive tests preterm birth, especially when used in combination. Other predictive tools like Actim Partus and Partosure are effective for symptomatic women, but their role in surveillance of asymptomatic women is unclear. Cervical cerclage is effective in reducing preterm birth in women with previous losses, but the role of progesterone and pessaries remains debated. Steroids remain one of the most effective antenatal intervention, but they need to be administered within a tight timeframe in order to confer maximal benefit. The role of PSCs in predicting the timing of birth and targeting women at highest risk to appropriate interventions is therefore crucial in optimizing care and improving outcomes. Conclusions: Nearly every step of management is still debated although many have a strong evidence-base and effective interventions do exist. The challenge is finding the optimal management pathway, and details of which populations benefit from which interventions need to be evaluated. While evidence continues to be collated, the poor outcomes of preterm birth and the multiple options available to reduce them justify preterm birth surveillance clinics being resourced.

An audit of in-utero transfers in a district general hospital

Objective: To assess the quantity and nature of transfers from a district general hospital with the aim of identifying suitable outcome measures for the assessment of future service improvements. Background: In-utero transfer is an essential part of daily obstetric practice. A need for an in-utero transfer will arise if the referring unit is unable to cope with the particular clinical condition at the time of transfer for a variety of reasons including: neonatal gestational thresholds, specialist maternal care, antenatal diagnosis requiring specialist postnatal care, bed/cot capacity or staffing issues. It has been reported that most major perinatal centres in the United Kingdom are regularly unable to meet in-house demand. Approximately 25% of women will remain undelivered 96 h after in-utero transfer. To avoid in-utero transfers, which is clearly a source of significant stress and anxiety for parents, the rationale for transfer has to be clear and the final decision made at consultant obstetric level. Method: Retrospective analysis of case notes of women who had in-utero transfers from 01/01/15 to 30/08/15. Results: 39 in-utero transfers identified over the 6 months period. Gestations ranged from 24 + 4 to 36 weeks. 34 of the transfers involved singletons, the other 5 were twin pregnancies. 36 out of the 39 patients (92%) had consent for transfer documented in their notes/IUT proforma. 72% of the transfers were due to cot availability (>28 weeks) in our unit, 10% of these being more that 34 weeks gestation. 14 patients (36%) required tocolytics i.e. Nifedipine or Atosiban prior to or during transfer. Only 33% of the in-utero transfers delivered at the receiving hospital. All 12 patients (31%) with a positive actim partus on transfer were discharged home. Conclusion and recommendations: Our results highlight an apparent lack of capacity in the neonatal service, resulting in considerable numbers in-utero transfers. We need to document maternal consent with every patient being transferred in-utero and to review and develop guidance on the use of Actim Partus in the department.

Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement

ObjectiveTo compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement. Study designWe performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result. ResultsIn total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively. ConclusionAccording to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study.

EP18.02: Comparison of partosure (PAMG‐1) and actim partus (phlGFBP‐1) for the prediction of preterm delivery in patients with preterm labour and a short cervix

EP18.02: Comparison of partosure (<scp>PAMG</scp>‐1) and actim partus (<scp>phlGFBP</scp>‐1) for the prediction of preterm delivery in patients with preterm labour and a short cervix

IGFBP-1 marker of cervical ripening and predictor of preterm birth

Aim To establish a correlation between positive values of IGFBP-1(>10 mg/L, Actim Partus Test, APT) and premature cervical ripening in imminent preterm labor. Methods A prospective study was conducted in primary health care centers in Tuzla, Gynecology and Obstetrics Clinic of the University Clinical Centre in Tuzla and General Hospital Tešanj. The study included 50 women (singleton pregnancy, 28-37 week) with imminent preterm labor diagnosed by cervical biometry and modified Bishop score) (examinees) and 30 healthy pregnant women (control group). The presence of IGFBP-1 was tested in cervical secretion several times in weeks 28-37 until a positive test was shown. Results IGFBP-1 was positive in 43 (86%) examinees and in six (20%) patients from the control group (p=0.001). In 31 (62%) examinees APT was positive in weeks 28-30, and in nine (18%) in weeks 31- 33, while three (6%) examinees had positive test in 34-37 week; in the control group, three (10%) were tested positive in weeks 31-33 and three (10%) in weeks 34-37. At first testing (28-30 weeks) APT was statistically significantly more frequently positive in the examined group (p<0.05). Later, tests did not find statistically significant difference in the frequency of positivity between the control and examined group (p=0.08). Conclusion Elevated values of IGFBP -1 in cervical secretion were highly correlated with preterm labor. Screening for IGFBP could help in preventing preterm labor and its complications.

Phosphorylated IGFBP-1 in predicting successful vaginal delivery in post-term pregnancy.

PurposeTo estimate whether phosphorylated IGFBP-1 (phIGFBP-1) in cervical secretion in term and post-term pregnancies can predict spontaneous onset of labor or vaginal delivery.MethodsA prospective cohort study of 167 women in singleton term and post-term pregnancies, was conducted at 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, between 2013 and 2014. phIGFBP-1 test (Actim Partus Medix Biochemica), ultrasound cervix assessment and Bishop score were analyzed in the study group. Spontaneous onset of labor was the primary and vaginal delivery was the secondary outcome.ResultsIn 32.5 % of patients, spontaneous uterine contractions appeared. 67.5 % of women delivered vaginally, 32.5 % had cesarean section. phIGFBP-1 test predicted spontaneous onset of labor (sensitivity 0.69, specificity of 0.42) and successful vaginal delivery (0.67, 0.48). In the prediction of spontaneous delivery onset ultrasound cervical assessment and phIBFBP-1 had comparable sensitivity and in the prediction of successful vaginal birth all three tests had comparable sensitivity. The time from preinduction to spontaneous onset of delivery was significantly shorter in women with positive phIGFBP-1 test (13.65 ± 6.7 vs 20.75 ± 2.6 h; p = 0.006).ConclusionA test for phIGFBP1 presence might be an additional tool for predicting both spontaneous onset of labor and successful vaginal delivery in post-term pregnancies.

Correlation of cervical length, fetal fibronectin, phIGFBP-1, and cytokines in spontaneous preterm birth up to 14 days from sampling.

The aim of this study was to determine the relationship between sonographic cervical length, fetal fibronectin (fFN), phIGFBP-1 (actim partus test), cytokines (IL-6, IL-2R, and TNF-α), and spontaneous preterm birth (SPTB) up to 14 days from sampling. Fifty-eight patients were recruited in a period of 6 months from September 2013 until March 2014 with symptoms or complaints suggestive of preterm labor. Consenting women were treated according to usual hospital protocol, with addition of vaginal swabs taken for fetal fibronectin, phIGFBP-1 (actim partus test) and cervical IL6, IL2R, and TNF-α. The outcome variable was occurrence of preterm delivery within 14 days from the day of hospital admission. Thirty-six patients (62.07%) were delivered within 14 days from admission. Our results indicated that the cervical length significantly inversely correlates with the concentration of IL-6 in the CVF (Spearman's coefficient R=-0.382, P<0.05). Cervical length also correlated with a positive phIGFBP-1 test, i.e., patients with a positive test had an average cervical length of 18.5±4.63 mm, which is significantly lower than patients with a negative test -23.43±7.39 mm (P=0.003). The studied biochemical markers were only moderately successful in the prediction of preterm delivery.

Predictive value of phosphorylated insulin-like growth factor binding protein-1 (PIGFBP-1) (bedside test) in preterm labor.

This study evaluated the predictive value of phosphorylated insulin like growth factor binding protein-1 in cervical secretion as bedside test for prediction of preterm labor in symptomatic women. A total of 57 patients with singleton pregnancy at 24-34 weeks gestation, with symptoms suggestive of preterm labor were included in this study. A rapid cervical sample for PIGFBP-1 determination (Actim partus test, Medix Biochemical, and Kaunianen, Finland) was taken by means of a polyester-tipped swab during a speculum examination of the cervix, and extracted with specimen- extraction solution. We analyzed the prevalence of preterm labor in these patients within seven days upon admission. And calculate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for PIGFBP-1. This study was done at Kuwait Oil Company hospital (KOC) and Taiba hospital (Kuwait) during the period between April 2011 and June 2012. The test was positive in 50.9% of patients and negative in 49.1%, among those tests was positive 64% delivered less than a week, and among those tests was negative 35.7 delivered less than one week, with 74.3% sensitivity, 61% spesivity, 76.3% PPV and 73.6% NPV.

PPO.26 Actim partus – the first year at St. Michael’s Hospital, Bristol

IntroductionActim Partus use as a predictor of preterm labour in symptomatic women was audited. It was hoped that clinical outcomes would match anticipated efficacy and that Actim Partus would serve...

Evaluation of pregnant women at risk of preterm delivery by correlating ultrasound markers with Insulin-like growth factor binding protein-1

The aim of the study was to assess the preterm birth risk, by correlating Actim Partus test with ultrasound markers. The present study was conducted in the Clinic of Obstetrics and Gynecology from Municipal Hospital, Craiova from Romania, on 67 pregnant women from whom we selected 34 at risk of preterm delivery with gestational ages between 22 and 32 weeks. To include pregnant women in the premature birth risk group we observed personal obstetrical history, transvaginal ultrasound cervical length (CL) (≤ 25 mm, ± funneling), Actim Partus test and the correlations between these elements. For inclusion in the group we need to determinate CL and test every two weeks. Our results showed that the women who had a concentration of pheripheral insulin-like growth factor binding protein-1 less than 10 ug/l (negative) did not deliver prematurely or in the next two weeks following the testing. None of the women tested gave birth before 35 weeks of pregnancy. Treatment was effective in these cases. Evidence suggests that a CL < 25-25 mm increases moderately preterm birth rate at < 37 weeks, although values between 20 and 25 mm do not exclude preterm birth, as well as associating funneling. Actim Partus test is a quick, facile and reliable test, which requires no additional equipment, and could be further used to monitor the rate of premature births in pregnant women. <br/><a href=

740: Comparison of the Actim Partus test and fetal fibronectin test in combination with cervical length in the prediction of spontaneous preterm delivery in symptomatic women: a post-hoc analysis

740: Comparison of the Actim Partus test and fetal fibronectin test in combination with cervical length in the prediction of spontaneous preterm delivery in symptomatic women: a post-hoc analysis

Impact of antenatal tests on acute in-utero transfers

BackgroundFewer than 50% of mothers referred for acute in-utero transfer (IUT) from the East of England (EoE) region deliver within 7 days. Appropriate antenatal tests for symptomatic women are recommended.1...

Phosphorylated insulin-like growth factor binding protein-1 (ACTIM PARTUS) testing in management of threatened preterm labour

IntroductionPreterm labour is one of the commonly encountered problems in pregnancy complicating nearly 20% of women. It is not only a cause for increased perinatal morbidity and mortality, but also...

National survey of utilisation of tests for pre-term labour

IntroductionPrematurity is the leading cause of neonatal morbidity and mortality. However threatened pre-term labour is common and it is difficult to distinguish the subset of women who will deliver. We...

The Actim Partus test to predict pre-term birth in asymptomatic high-risk women

The Actim Partus test has been shown to be a useful predictor of pre-term birth in symptomatic women, but limited research has been carried out in high-risk asymptomatic women. This is a pilot study to evaluate the use of this test as a direct comparator with the fetal fibronectin test. All asymptomatic high-risk women attending a pre-term surveillance clinic over a 9-month period, took an Actim Partus and fetal fibronectin test, between 23 +0–24 +6 weeks’ gestation. A total of 45 women were eligible. The positive and negative predictive values of the Actim Partus test for delivery at ≤ 37 weeks’ gestation were 0% and 70%, respectively, compared with the fetal fibronectin test, with values of 67% and 79%, respectively. It was concluded that the Actim Partus test did not perform well as a predictor of pre-term birth in high-risk asymptomatic women.

The use of phosphorylated insulin-like growth factor binding protein-1, the Actim Partus test to predict preterm birth in asymptomatic high-risk women

ObjectiveThe Actim Partus test has been shown to be a useful predictor of preterm birth in symptomatic women but it has not been assessed in high-risk asymptomatic women. This is...