Birth In Asymptomatic High-risk Women Research Articles

Performance of QUiPP App v.2 tool for prediction of preterm birth in asymptomatic high-risk women attending preterm specialist clinic: external validation study.

To validate externally the QUiPP App v.2 algorithms in an independent cohort of high-risk asymptomatic women attending a preterm birth (PTB) surveillance clinic in Ireland. This was a retrospective, single-center, observational study assessing discrimination and calibration of the QUiPP App v.2 at six predetermined clinical timepoints (PTB at < 30, < 34 and < 37 weeks of pregnancy and PTB within 1, 2 and 4 weeks of testing). Discrimination was assessed by estimating the area under the receiver-operating-characteristics curve (AUC) and sensitivity at fixed false-positive rates of 5%, 10% and 20%. Model calibration was assessed to evaluate the concordance between expected and observed outcomes. P-values < 0.05 were considered statistically significant. No adjustments for treatment effects were made. Overall, 762 women with 1660 PTB surveillance clinic visits using the QUiPP App v.2 between 2019 and 2022 were analyzed. The study population included 142 (18.6%) patients who later experienced a PTB. The QuiPP App's performance in the prediction of short-term outcomes, such as birth within 1 week (AUC, 0.866 (95% CI, 0.755-0.955)), 2 weeks (AUC, 0.721 (95% CI, 0.569-0.854)) and 4 weeks (AUC, 0.775 (95% CI, 0.699-0.842)), and delivery at < 30 weeks (AUC, 0.747 (95% CI, 0.613-0.865)), was superior to its ability to predict longer-term outcomes (PTB at < 37 weeks: AUC, 0.631 (95% CI, 0.596-0.668)). Calibration was generally good for low-risk results, as the predicted risk in these patients tended to match the observed incidence. However, in women deemed to be at greater risk of PTB, the predicted probability superseded the observed incidence of PTB. The QUiPP App v.2 accurately discriminates women who are at short-term risk of PTB. A treatment paradox may influence calibration in high-risk women. Further research is needed to ascertain if QuiPP treatment thresholds can be safely adjusted in women receiving prophylactic treatment to prevent PTB, and whether this improves the outcome. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Predicting spontaneous preterm birth in asymptomatic high-risk women with cervical cerclage.

To determine the performance of the predictive markers of spontaneous preterm birth, cervicovaginal quantitative fetal fibronectin (fFN) and cervical length, in asymptomatic high-risk women with transabdominal, history-indicated or ultrasound-indicated cervical cerclage. This was a secondary analysis of a prospective cohort of asymptomatic high-risk women with cervical cerclage and no other prophylactic intervention (including progesterone), who attended the preterm birth clinic at a central London teaching hospital between October 2010 and September 2016. Women had either transabdominal cerclage, placed prior to conception, history-indicated cerclage, placed before 14 weeks' gestation, or ultrasound-indicated cerclage for a short cervix (< 25 mm), placed before 24 weeks. All women underwent serial cervical length assessment on transvaginal ultrasound in the second trimester (16-28 weeks), and quantitative fFN testing from 18 weeks onward. Test performance was analyzed for the prediction of spontaneous preterm birth before 30 weeks (cerclage failure), 34 weeks and 37 weeks, using receiver-operating-characteristics (ROC)-curve analysis. Overall, 181 women were included in the analysis. Cervical length and fFN were strong predictors of spontaneous preterm birth before 30 weeks in women with cerclage, with areas under the ROC curve (AUC) of 0.86 (95% CI, 0.79-0.94) and 0.84 (95% CI, 0.75-0.92), respectively. Cervical length was a better predictor of preterm birth before 30 weeks in women with history-indicated compared to those with ultrasound-indicated cerclage, although both showed clinical utility (AUC, 0.96 (95% CI, 0.91-1.00) vs 0.79 (95% CI, 0.66-0.91); P = 0.01). Quantitative fFN was a strong predictor of spontaneous preterm birth before 30 weeks in women with history-indicated cerclage (AUC, 0.91 (95% CI, 0.75-1.00)) and retained clinical utility in those with ultrasound-indicated cerclage (AUC, 0.76 (95% CI, 0.64-0.89)). There were no spontaneous deliveries before 34 weeks in women with a transabdominal cerclage, so AUC was not calculated. Delivery was delayed significantly in this group (P < 0.01). Cervical length and quantitative fFN retain clinical utility for the prediction of spontaneous preterm birth in women with cervical cerclage, and prediction is best in women with a history-indicated stitch. These tests can be relied upon to discriminate risk and have utility when planning clinical management with regard to treatment failure. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Vaginal progesterone for prevention of preterm birth in asymptomatic high-risk women with a normal cervical length: a systematic review and meta-analysis protocol

BackgroundPreterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8 to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronised) progesterone to prevent PTB in women with a shortened cervix (< 25 mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length.MethodsStudies will be sourced from MEDLINE, Embase and Cochrane Register of Trials (CENTRAL) from their inception onwards with the search terms ‘progesterone’ and ‘preterm birth’. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB < 37 weeks, with secondary outcomes of sPTB < 34 weeks.Two independent reviewers will conduct study screening at abstract and full text level, data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals.DiscussionThis review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high-risk singleton pregnancies and normal cervical length.Trial registrationPROSPERO CRD42020152051

Cervical Pessary to Prevent Preterm Birth in Asymptomatic High-Risk Women: A Systematic Review and Meta-analysis

(Abstracted from Am J Obstet Gynecol 2020;223:42–65.e2) Preterm birth is associated with a multitude of short-term complications in infants compared with term delivery. These short-term complications include respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, sepsis, intraventricular hemorrhage, periventricular leukomalacia, and retinopathy of prematurity.

Prediction of spontaneous preterm birth using fetal fibronectin in women with a low-lying placenta

Objective: To determine the effect of a low-lying placenta on the concentration of quantitative fetal fibronectin (qfFN) in the cervicovaginal fluid (CVF), and predictive accuracy for spontaneous preterm birth in asymptomatic high-risk women (18 + 0–24 + 0 weeks gestation). Methods: Median concentrations of qfFN were compared in women who had a low-lying placenta, covering the cervical os (n = 61) to matched controls (n= 61) without a low-lying placenta. Proportions of women with raised qfFN concentrations (>10 ng/ml), and false positive and negative rates (FPR and FNR) for spontaneous preterm delivery were also compared. Results: The median concentration of qfFN in women with low-lying placenta was 5.0 ng/mL, compared with 6.0 ng/mL in controls. Proportion of women with raised levels (>10 ng/mL), positive levels (>50 ng/mL) and very high levels (>200 ng/mL) were similar in both groups (62.3% versus 59.0%, 16.3% versus 22.0% and 6.5% versus 4.9%, p > 0.05 for all thresholds). The FPR and FNR rate for delivery before 34 and 37 weeks were also comparable (FPR 90.0% versus 85.7% and 80.0% versus 78.6%; FNR 5.8% versus 4.3% and 9.8% versus 8.5%).Conclusions: CVF qfFN concentrations in asymptomatic high-risk women are not affected by the presence of a low-lying placenta.

Biomarkers and Cervical Length to Predict Spontaneous Preterm Birth in Asymptomatic High-Risk Women

To investigate whether biomarkers from different pathways of spontaneous preterm birth (cervical membrane degradation [fetal fibronectin], cervical remodeling [soluble E-cadherin], and inflammation (elafin, surfactant protein-D, interleukin-6 [IL-6]) were superior to one biomarker alone in predicting preterm birth. Our secondary objective was to examine the association of these biomarkers with cervical length in predicting preterm birth. We performed a single-center, prospective cohort study from August 2011 to November 2012 of asymptomatic women at risk for spontaneous preterm birth as a result of obstetric and gynecologic history. Cervicovaginal fluid and cervical length measurements were collected at two time points (20-23 6/7 weeks and 24-27 6/7 weeks of gestation). Among the 104 women with complete data, the preterm birth rate was 24.5%. Prior preterm birth (P=.006) and cervical length at visit 1 (P=.003) were significantly associated with preterm birth, whereas fetal fibronectin and median biomarker levels (elafin, soluble E-cadherin, IL-6) were not. Median surfactant protein-D levels at visit 1 by preterm birth status were statistically but not clinically different (0.44 ng/mL compared with 0.40 ng/mL, P<.001). Analyses of biomarkers from more than one pathway were not superior to single biomarker analyses in predicting prematurity. Neither inclusion of biomarkers nor fetal fibronectin improved the predictive ability of cervical length alone. Cervical length assessment and obstetric history but not fetal fibronectin or biomarkers were useful in the risk stratification of women identified to be at greatest risk for spontaneous preterm birth. II.

PM.61 The Use of Quantitative Fetal Fibronectin to Predict Obstetric Outcome: A Comparison of a New and Established Quantitative Bedside Analyser in Asymptomatic High-Risk Women

Background Preterm birth (PTB) remains a significant cause of neonatal morbidity and mortality. The most accurate predictors of PTB are ultrasound determined cervical length (CL) and fetal fibronectin (fFN)1. Quantitative...

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 value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women

Objectives. To determine the value of the combined use of fetal fibronectin (fFN) testing and transvaginal ultrasound measurement of cervical length (CL) for prediction of preterm birth (PTB) in asymptomatic high-risk women.Methods. One hundred and forty-seven asymptomatic women at high-risk of PTB were referred to specialist antenatal clinics and underwent CL and fFN testing over a 12-month period. Women had both tests undertaken between 22+0 and 30+0 weeks' gestation, on one or more occasions.Results. In those who labored spontaneously (n = 132), positive fFN and CL ≤25 mm was associated with a 53% risk of PTB at <37+0 weeks' gestation, compared to a 10% risk in those with a negative fFN and CL > 25 mm. With a known CL, the addition of positive fFN yielded significant hazard ratios regardless of CL (CL > 25 mm-HR 2.78, CL ≤25 mm-HR 3.14, p <0.05). The hazard ratios were insignificant when CL results were added to a known fFN.Conclusions. In high-risk asymptomatic women, fFN may be used as a primary screening tool with CL measurement being reserved for those with a positive fFN result. Further prospective studies are needed to confirm our findings.

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...