Outcomes of induction versus spontaneous onset of labour at 40 and 41 GW: findings from a prospective database, Sri Lanka.

OBJECTIVES: The World Health Organization recommends induction of labour (IOL) for low risk pregnancy from 41 + 0 gestational weeks (GW). Nevertheless, in Sri Lanka IOL at 40 GW is a common practice. This study compares maternal/newborn outcomes after IOL at 40 GW (IOL40) or 41 GW (IOL41) versus spontaneous onset of labour (SOL). METHODS: Data were extracted from the routine prospective individual patient database of the Soysa Teaching Hospital for Women, Colombo. IOL and SOL groups were compared using logistic regression. RESULTS: Of 13,670 deliveries, 2359 (17.4%) were singleton and low risk at 40 or 41 GW. Of these, 456 (19.3%) women underwent IOL40, 318 (13.5%) IOL41, and 1585 (67.2%) SOL. Both IOL40 and IOL41 were associated with an increased risk of any maternal/newborn negative outcomes (OR = 2.21, 95%CI = 1.75-2.77, p < 0.001 and OR = 1.91, 95%CI = 1.47-2.48, p < 0.001 respectively), maternal complications (OR = 2.18, 95%CI = 1.71-2.77, p < 0.001 and OR = 2.34, 95%CI = 1.78-3.07, p < 0.001 respectively) and caesarean section (OR = 2.75, 95%CI = 2.07-3.65, p < 0.001 and OR = 3.01, 95%CI = 2.21-4.12, p < 0.001 respectively). Results did not change in secondary and sensitivity analyses. CONCLUSIONS: Both IOL groups were associated with higher risk of negative outcomes compared to SOL. Findings, potentially explained by selection bias, local IOL protocols and CS practices, are valuable for Sri Lanka, particularly given contradictory findings from other settings.

Risk-adjusted operative delivery rates and maternal-neonatal outcomes as measures of quality assessment in obstetric care: a multicenter prospective study.

BACKGROUND: Although the evaluation of caesarean delivery rates has been suggested as one of the most important indicators of quality in obstetrics, it has been criticized because of its controversial ability to capture maternal and neonatal outcomes. In an "ideal" process of labor and delivery auditing, both caesarean (CD) and assisted vaginal delivery (AVD) rates should be considered because both of them may be associated with an increased risk of complications. The aim of our study was to evaluate maternal and neonatal outcomes according to the outlier status for case-mix adjusted CD and AVD rates in the same obstetric population. METHODS: Standardized data on 15,189 deliveries from 11 centers were prospectively collected. Multiple logistic regression was used to estimate the risk-adjusted probability of a woman in each center having an AVD or a CD. Centers were classified as "above", "below", or "within" the expected rates by considering the observed-to-expected rates and the 95% confidence interval around the ratio. Adjusted maternal and neonatal outcomes were compared among the three groupings. RESULTS: Centers classified as "above" or "below" the expected CD rates had, in both cases, higher adjusted incidence of composite maternal (2.97%, 4.69%, 3.90% for "within", "above" and "below", respectively; p = 0.000) and neonatal complications (3.85%, 9.66%, 6.29% for "within", "above" and "below", respectively; p = 0.000) than centers "within" CD expected rates. Centers with AVD rates above and below the expected showed poorer and better composite maternal (3.96%, 4.61%, 2.97% for "within", "above" and "below", respectively; p = 0.000) and neonatal (6.52%, 9.77%, 3.52% for "within", "above" and "below", respectively; p = 0.000) outcomes respectively than centers with "within" AVD rates. CONCLUSIONS: Both risk-adjusted CD and AVD delivery rates should be considered to assess the level of obstetric care. In this context, both higher and lower-than-expected rates of CD and "above" AVD rates are significantly associated with increased risk of complications, whereas the "below" status for AVD showed a "protective" effect on maternal and neonatal outcomes.

Diabetes in pregnancy: timing and mode of delivery.

Diabetes in pregnancy represents a risk condition for adverse maternal and feto-neonatal outcomes and many of these complications might occur during labor and delivery. In this context, the obstetrician managing women with pre-existing and gestational diabetes should consider (1) how these conditions might affect labor and delivery outcomes; (2) what are the current recommendations on management; and (3) which other factors should be considered to decide about the timing and mode of delivery. The analysis of the studies considered in this review leads to the conclusion that the decision to deliver should be primarily intended to reduce the risk of stillbirth, macrosomia, and shoulder dystocia. In this context, this review provides useful information for managing specific subgroups of diabetic women that may present overlapping risk factors, such as women with insulin-requiring diabetes and/or obesity and/or prenatal suspicion of macrosomic fetus. To date, the lack of definitive evidences and the complexity of the problem suggest that the "appropriate" clinical management should be customized according with the clinical condition, the type and mode of intervention, its consequences on outcomes, and considering the woman's consent and informed decisions.

The implications of diagnosis of small for gestational age fetuses using European and South Asian growth charts: an outcome-based comparative study.

The antenatal condition of small for gestational age (SGA) is significantly associated with perinatal morbidity and mortality and it is known that there are significant differences in birth weight and fetal size among different populations. The aim of our study was to assess the impact on outcomes of the diagnosis of SGA according to Bangladeshi and European antenatal growth charts in Sri Lankan population. The estimated fetal weight before delivery was retrospectively reviewed according to Bangladeshi and European growth references. Three groups were identified: Group 1-SGA according to Bangladeshi growth chart; Group 2-SGA according to European growth chart but not having SGA according to Bangladeshi growth chart; Group 3-No SGA according to both charts. There was a difference in prevalence of SGA between Bangladeshi and European growth charts: 12.7% and 51.7%, respectively. There were statistically significant higher rates in emergency cesarean section, fetal distress in labour, and intrauterine death (P < 0.001) in Group 1 compared with Group, 2 and 3. No differences of outcomes occurred between Groups 2 and 3. Our study demonstrated that only cases diagnosed as SGA according to population-based growth charts are at risk of adverse outcome. The use of inappropriate prenatal growth charts might lead to misdiagnosis and potential unnecessary interventions.

Umbilical Vein Blood Flow in Uncomplicated Pregnancies: Systematic Review of Available Reference Charts and Comparison with a New Cohort.

The objectives of the study were (1) to perform a systematic review of the available umbilical vein blood flow volume (UV-Q) reference ranges in uncomplicated pregnancies; and (2) to compare the findings of the systematic review with UV-Q values obtained from a local cohort. Available literature in the English language on this topic was identified following the PRISMA guidelines. Selected original articles were further grouped based on the UV sampling sites and the formulae used to compute UV-Q. The 50th percentiles, the means, or the best-fitting curves were derived from the formulae or the reported tables presented by authors. A prospective observational study of uncomplicated singleton pregnancies from 20+0 to 40+6 weeks of gestation was conducted to compare UV-Q with the results of this systematic review. Fifteen sets of data (fourteen sets belonging to manuscripts identified by the research strategy and one obtained from our cohort) were compared. Overall, there was a substantial heterogeneity among the reported UV-Q central values, although when using the same sampling methodology and formulae, the values overlap. Our data suggest that when adhering to the same methodology, the UV-Q assessment is accurate and reproducible, thus encouraging further investigation on the possible clinical applications of this measurement in clinical practice.

The clinical interpretation and significance of electronic fetal heart rate patterns 2 h before delivery: an institutional observational study.

PURPOSE: To evaluate the clinical significance of intrapartum fetal heart rate (FHR) monitoring in low-risk pregnancies according to guidelines and specific patterns. METHODS: An obstetrician, blinded to neonatal outcome, retrospectively reviewed 198 low-risk cases that underwent continuous electronic fetal monitoring (EFM) during the last 2 h before delivery. The tracings were interpreted as normal, suspicious or pathological, according to specific guidelines of EFM and by grouping the different FHR patterns considering baseline, variability, presence of decelerations and bradycardia. The EFM groups and the different FHR-subgroups were associated with neonatal acid base status at birth, as well as the short-term neonatal composite outcome. Comparisons between groups were performed with Kruskal-Wallis test. Differences among categorical variables were evaluated using Fisher's exact test. Significance was set at p < 0.05 level. RESULTS: Significant differences were found for mean pH values in the three EFM groups, with a significant trend from "normal" [pH 7.25, 95 % confidence interval (CI) 7.28-7.32] to "pathological" tracings (pH 7.20, 95 % CI 7.17-7.13). Also the rates of adverse composite neonatal outcome were statistically different between the two groups (p < 0.005). Among the different FHR patterns, tracings with atypical variable decelerations and severe bradycardia were more frequently associated with adverse neonatal composite outcome (11.1 and 26.7 %, respectively). However, statistically significant differences were only observed between the subgroups with normal tracings and bradycardia. CONCLUSIONS: In low-risk pregnancies, there is a significant association between neonatal outcome and EFM classification. However, within abnormal tracings, neonatal outcome might differ according to specific FHR pattern.

Ascites in puerperium: a rare case of atypical pseudo-Meigs' syndrome complicating the puerperium.

PURPOSE: We report the case of puerperal ascites, associated with elevated CA125 levels and secondary to a uterine myoma. The literature on pseudo-Meigs' syndrome associated with pregnancy was reviewed. CASE: A 35-year-old woman complained of abdominal distension 2 days after a spontaneous vaginal delivery. A mass of 5 cm in the right uterine corner had been detected during the first trimester ultrasound and had been diagnosed as subserosal myoma. Physical examination and ultrasound revealed massive ascites. Computed tomography confirmed ascites and laboratory investigations showed CA125 raised levels. Cytology of ascitic fluid resulted negative for malignancy. A laparotomy was performed and a large pedunculated myoma was removed. A final diagnosis of atypical pseudo-Meigs' syndrome was performed, being computed tomography and chest X-ray negative for pleural effusion. CONCLUSIONS: To the best of our knowledge, this is the first case of pseudo-Meigs' syndrome caused by a uterine leiomyoma described in puerperium and without hydrothorax. Though ascites is very rare in obstetrics, it should be considered when evaluating puerperal patients complaining of abdominal distension.

Implementation of the WHO manual for Robson classification: an example from Sri Lanka using a local database for developing quality improvement recommendations.

OBJECTIVES: This study aimed at describing the use of a prospective database on hospital deliveries for analysing caesarean section (CS) practices according to the WHO manual for Robson classification, and for developing recommendations for improving the quality of care (QoC). DESIGN: Observational study. SETTING: University Obstetric Unit at De Soysa Hospital for Women, the largest maternity unit in Sri Lanka. DATA COLLECTION AND ANALYSIS: For each childbirth, 150 variables were routinely collected in a standardised form and entered into a database. Data were routinely monitored for ensuring quality. Information on deliveries occurring from July 2015 to June 2017 were analysed according the WHO Robson classification manual. Findings were discussed internally to develop quality improvement recommendations. RESULTS: 7504 women delivered in the hospital during the study period and at least one maternal or fetal pathological condition was reported in 2845 (37.9%). The CS rate was 30.0%, with 11.9% CS being performed prelabour. According to the Robson classification, Group 3 and Group 1 were the most represented groups (27.0% and 23.1% of population, respectively). The major contributors to the CS rate were group 5 (29.6%), group 1 (14.0%), group 2a (13.3%) and group 10 (11.5%). The most commonly reported indications for CS included abnormal cardiotocography/suspected fetal distress, past CS and failed progress of labour or failed induction. These suggested the need for further discussion on CS practices. Overall, 18 recommendations were agreed on. Besides updating protocols and hands-on training, activities agreed on included monitoring and supervision, criterion-based audits, risk management meetings and appropriate information for patients, and recommendations to further improve the quality of data. CONCLUSIONS: This study provides an example on how the WHO manual for Robson classification can be used in an action-oriented manner for developing recommendations for improving the QoC, and the quality of data collected.

Implementation of an individual patient prospective database of hospital births in Sri Lanka and its use for improving quality of care.

OBJECTIVES: This study was aimed at piloting a prospective individual patient database on hospital deliveries in Colombo, Sri Lanka, and at exploring its use for developing recommendations for improving quality of care (QoC). DESIGN: Observational study. SETTING: De Soysa Maternity Hospital, the largest referral hospital for maternity care in Sri Lanka. DATA COLLECTION AND ANALYSIS: From July 2015 to June 2017, 150 variables were collected for each delivery using a standardised form and entered into a database. Data were analysed every 8 months, and the results made available to local staff. Outcomes of the study included: technical problems; data completeness; data accuracy; key database findings; and use of data. RESULTS: 7504 deliveries were recorded. No technical problem was reported. Data completeness exceeded that of other existing hospital recording systems. Less than 1% data were missing for maternal variables and less than 3% for newborn variables. Mistakes in data collection and entry occurred in 0.01% and 0.09% of maternal and newborn data, respectively. Key QoC indicators identified in comparison with international standards were: relatively low maternal mortality (0.053%); relatively high maternal near-miss cases (3.4%); high rate of induction of labour (24.6%), caesarean section (30.0%) and episiotomy (56.1%); relatively high rate of preterm births (9.4%); low birthweight rate (16.5%); stillbirth (0.97%); and of total deaths in newborn (1.98%). Based on key indicators identified, a list of recommendations was developed, including the use checklists to standardise case management, training, clinical audits and more information for patients. A list of lessons learnt with the implementation of the data collection system was also drawn. CONCLUSIONS: The study shows that the implemented system of data collection can produce a large quantity of reliable information. Most importantly, this experience provides an example on how database findings can be used for discussing hospital practices, identifying gaps and to agree on recommendations for improving QoC.

The role of mannose-binding lectin gene polymorphisms in women with recurrent bacterial vaginosis.

OBJECTIVE: The objective of the study was to examine mannose-binding lectin gene (MBL2) polymorphisms in women with recurrent episodes of bacterial vaginosis (BV). STUDY DESIGN: Seventy-one women with at least 4 episodes of BV in the last 12 months and 130 healthy controls were enrolled to evaluate all 3 variant alleles of the MBL2 gene (polymorphisms at positions 52, 54, and 57 in the first exon of the MBL2 gene). RESULTS: No statistically significant differences in MBL2 polymorphism allelic and genotype frequencies were observed between women with recurrent BV and controls. Allele A (wild type) was present, respectively, in 78% of patients with recurrent BV and 77% of controls, whereas the allele 0 was present in 22% of women with recurrent BV and 23% of controls. MBL2 genotype and allelic frequencies were similar in the 2 groups, and the 2 populations were in accordance with the Hardy-Weiberg equilibrium. CONCLUSION: Our results indicate that MBL2 gene polymorphisms do not seem to be involved in susceptibility to recurrences of BV in gynecological patients.

First-trimester intrauterine hematoma and outcome of pregnancy.

OBJECTIVE: To evaluate the outcome of pregnancies complicated by first-trimester intrauterine hematoma. METHODS: An analysis was performed on 248 cases. The pregnancy outcome was correlated with hematoma volume, gestational age (weeks), and maternal age (years). RESULTS: One hundred eighty-two cases were eligible for the study. Clinical complications occurred in 38.5% of the cases (adverse outcome group). Spontaneous abortion (14.3%), fetal growth restriction (7.7%), and preterm delivery (6.6%) were the most frequent clinical conditions observed. Considering the hematoma variables in adverse and favorable outcome groups, we found a significant difference only for gestational age at diagnosis. The median gestational age was significantly lower (P < .02) in the adverse outcome group (7.27, I and III quartiles 6.22-8.78) than in the favorable outcome cases (8.62, I and III quartiles 6.70-9.98). Among clinical conditions, the median gestational age was significantly lower (P = .02) in pregnancies complicated by spontaneous abortion (6.60, I and III quartiles 5.95-8.36) than in cases not ending in a miscarriage (8.50, I and III quartiles 6.70-9.91). The overall risk of adverse outcome was 2.4 times higher when the hematoma was diagnosed before 9 weeks (odds ratio 2.37, 95% confidence interval 1.20-4.70). In particular, intrauterine hematoma observed before 9 weeks significantly increases the risk of spontaneous abortion (odds ratio 14.79, 95% confidence interval 1.95-112.09) CONCLUSION: Intrauterine hematoma can affect the outcome of pregnancy. The risk of spontaneous abortion is related to gestational age and is significantly increased if diagnosed before 9 weeks. LEVEL OF EVIDENCE: III.

Bacterial vaginosis and preterm delivery: an open question.

OBJECTIVE: To evaluate the prevalence of bacterial vaginosis in a population of Italian pregnant women and to study its association with adverse pregnancy outcomes, particularly preterm delivery. STUDY DESIGN: After giving informed consent, 598 women were consecutively enrolled at their first prenatal visit (13-18 weeks of gestation). The presence of bacterial vaginosis was assessed by Gram's method at 13-18 weeks of gestation (early bacterial vaginosis) and at 28-32 weeks of gestation (late bacterial vaginosis). Univariate and multiple logistic regression models of analysis were used to assess the statistical significance of the data. RESULTS: Preterm delivery occurred in 14.7% of pregnant women positivefor bacterial vaginosis at theirfirst prenatal visit and in 6.9% of healthy women (OR 1.6, CI 1.07-2.51). In patients with bacterial vaginosis, preterm delivery occurred more often in the 36th week of gestation (78.6%). CONCLUSION: The presence of bacterial vaginosis at an early gestational age is associated with preterm delivery, although in the study population the condition did not seem to be related to great prematurity.

Interinstitutional variation of caesarean delivery rates according to indications in selected obstetric populations: a prospective multicenter study.

The aim of the study was to identify which groups of women contribute to interinstitutional variation of caesarean delivery (CD) rates and which are the reasons for this variation. In this regard, 15,726 deliveries from 11 regional centers were evaluated using the 10-group classification system. Standardized indications for CD in each group were used. Spearman's correlation coefficient was used to calculate (1) relationship between institutional CD rates and relative sizes/CD rates in each of the ten groups/centers; (2) correlation between institutional CD rates and indications for CD in each of the ten groups/centers. Overall CD rates correlated with both CD rates in spontaneous and induced labouring nulliparous women with a single cephalic pregnancy at term (P = 0.005). Variation of CD rates was also dependent on relative size and CD rates in multiparous women with previous CD, single cephalic pregnancy at term (P < 0.001). As for the indications, "cardiotocographic anomalies" and "failure to progress" in the group of nulliparous women in spontaneous labour and "one previous CD" in multiparous women previous CD correlated significantly with institutional CD rates (P = 0.021, P = 0.005, and P < 0.001, resp.). These results supported the conclusion that only selected indications in specific obstetric groups accounted for interinstitutional variation of CD rates.

The application of the Ten Group classification system (TGCS) in caesarean delivery case mix adjustment. A multicenter prospective study.

BACKGROUND: Caesarean delivery (CD) rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this study was to evaluate whether the Ten Group classification system (TGCS) can be used in case-mix adjustment. METHODS: Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index), obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight) and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC) curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC) were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. RESULTS: Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS) identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively). In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024). CONCLUSIONS: The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the predictive discrimination of the risk adjusted model.