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Study protocol: the Labor Progression Study, LAPS - does the use of a dynamic progression guideline in labor reduce the rate of intrapartum cesarean sections in nulliparous women? A multicenter, cluster randomized trial in Norway.

ABSTRACT: The increasing rate of intrapartum cesarean sections is subject of attention and concern as it is associated with adverse outcomes. Labor dystocia is one of the most frequent indications for cesarean sections even though there is no consensus on criteria for labor dystocia. Traditionally the progression of labor follows guidelines based on Friedman's curve from the mid 1950s. In 2010 Zhang presented a new labor curve and a dynamic guideline for labor progression based on contemporary research. The main aim of this trial is to evaluate whether adhering to Zhang's guideline for labor progression, changes the intrapartum cesarean section rate in nulliparous women without jeopardising maternal and neonatal outcomes compared to a traditional guide line called the 4-h action line based on Friedman's curve.A multicenter cluster randomized trial including 14 birth care units in Norway is conducted. Seven units are randomized to use the 4-h action line guideline for labor progression and seven units are randomized to use Zhang's new dynamic guideline for labor progression, for all nulliparous women with a singleton fetus in a cephalic presentation and spontaneous onset of labor at term. Clinical outcomes are compared between the groups. The determination of the sample size (number of clusters and individuals) is based on a power calculation of intrapartum cesarean section, which is 9.2% in the study population (p1). Further, we expect that the intrapartum cesarean section rate will be 6.7% (p2) which is a 25% reduction, when using the new guideline. With a chosen significance level of 0.05, a power of 80% and p1?=?9.2% and p2?=?6.9%, we should include at least 14 clusters and 6582 individuals.Clinical consequences when using the guideline by Zhang have, to the best of our knowledge, not been investigated earlier. The results will provide a strong basis to make a qualified decision on whether it is beneficial to introduce a dynamic labor progression curve in contemporary obstetrics both nationally and internationally.Clinicaltrials, NCT02221427.

SUBMITTER: Bernitz S

PROVIDER: S-EPMC5683365 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Study protocol: the Labor Progression Study, LAPS - does the use of a dynamic progression guideline in labor reduce the rate of intrapartum cesarean sections in nulliparous women? A multicenter, cluster randomized trial in Norway.

Bernitz Stine S Dalbye Rebecka R Øian Pål P Zhang Jun J Eggebø Torbjørn Moe TM Blix Ellen E

BMC pregnancy and childbirth 20171113 1

<h4>Background</h4>The increasing rate of intrapartum cesarean sections is subject of attention and concern as it is associated with adverse outcomes. Labor dystocia is one of the most frequent indications for cesarean sections even though there is no consensus on criteria for labor dystocia. Traditionally the progression of labor follows guidelines based on Friedman's curve from the mid 1950s. In 2010 Zhang presented a new labor curve and a dynamic guideline for labor progression based on conte ...[more]

PMID: 29132336

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Project description:BackgroundWith the development of China's two-child-policy, vaginal birth after cesarean section (VBAC) has aroused public concern. It is important to understand the labour characteristics and intrapartum management of women attempting VBAC to enhance the rates of successful VBAC. The purpose of our research was to investigate the differences in the characteristics of labor, intervention measures and perinatal outcomes between women who had a VBAC and primiparas or multiparas not undergoing VBAC, providing clinical references of intrapartum management for women who are planning a VBAC.Material and methodsThis observational retrospective study enrolled all women who laboured spontaneously and who had a VBAC (n = 139) at the Second Affiliated Hospital of Wenzhou Medical University in China between 2016 and 2019. They were allocated into VBAC group A (the previous cesarean section was performed before dilation of the cervix) and VBAC group B (the previous cesarean section was performed after dilation of the cervix). The primipara control group included 149 primiparae, and the multipara control group included 155 multiparae with second vaginal birth. Durations of labor, intervention measures and perinatal outcomes were compared among the groups.ResultsThe durations of labor, intrapartum interventions and maternal and neonatal outcomes in VBAC group A were similar to those of the VBAC group B. However, all women who had a VBAC and those in VBAC group A had shorter first, second and the total stages of labor than primiparae. All women with VBAC and those in VBAC group B had longer second stage of labor, but shorter third stage of labor than multiparae. Oxytocin, labor analgesia and artificial rupture of membranes were administered less often in women with VBAC than in primiparae, while phloroglucinol was administered more often in women with VBAC than in multiparae. Women who had a VBAC were more likely to receive episiotomy and had higher incidences of postpartum hemorrhage than primipara and multipara women.ConclusionsLabor characteristics, intrapartum interventions and perinatal outcomes in women who had a VBAC with cervical dilation were similar to those in women who had a VBAC without cervical dilation before the previous cesarean section, but differed significantly from those of multiparae and primiparae who did not undergo VBAC.

Project description:IntroductionChildbirth experience is an increasingly recognized and important measure of quality of obstetric care. Previous research has shown that it can be affected by intrapartum care and how labor is followed. A partograph is recommended to follow labor progression by recording cervical dilation over time. There are currently different guidelines in use worldwide to follow labor progression. The two main ones are the partograph recommended by the World Health Organization (WHO) based on the work of Friedman and Philpott and a guideline based on Zhang's research. In our study we assessed the effect of adhering to Zhang's guideline or the WHO partograph on childbirth experience. Zhang's guideline describes expected normal labor progression based on data from contemporary obstetric populations, resulting in an exponential progression curve, compared with the linear WHO partograph. The choice of labor curve affects the intrapartum follow-up of women and this could potentially affect childbirth experience.Material and methodsThe Labor Progression Study (LaPS) study was a prospective, cluster randomized controlled trial conducted at 14 birth centers in Norway. Birth centers were randomized to either follow Zhang's guideline or the WHO partograph. Nulliparous women in active labor, with one fetus in cephalic presentation at term and spontaneous labor onset were included. At 4 weeks postpartum, included women received an online login to complete the Childbirth Experience Questionnaire (CEQ). Total score on the CEQ, the four domain scores on the CEQ, and scores on the individual items on the CEQ were compared between the two groups.ResultsThere were 1855 women in the Zhang group and 1749 women in the WHO partograph group. There was no difference in the total or domain CEQ scores between the two groups. We found statistically significant differences for two individual items; women in the Zhang group scored lower on positive memories and feeling of control.ConclusionsBased on our findings on childbirth experience there is no reason to prefer Zhang's guideline over the WHO partograph.

Project description:To compare intrapartum results associated with differing degrees of ketonuria in nulliparous women with gestational diabetes mellitus (GDM), we implemented a retrospective cohort study comparing clinical characteristics among differing degrees of ketonuria and the duration and distribution of ketonuria at different stages of labor. We also analyzed adverse maternal and neonatal outcomes for each group. A total of 570 GDM deliveries were included; of these, 238 had negative ketonuria (41.8%), 180 had moderate ketonuria (31.6%), and 152 had ketosis (26.6%). The proportion of patients with a family history of diabetes significantly increased as the degree of ketonuria increased (P < 0.001). Moreover, a significantly lower level of HOMA-IR (the insulin resistance index) was observed for the Negative group (P < 0.001). The triglyceride (TG) level was significantly higher in the Ketosis group (P < 0.001), and the total cholesterol (TC) levels significantly increased as the degree of ketonuria progressed (P < 0.001). There were also higher maternal blood sugar levels and a significantly higher proportion of oxytocin augmentation in ketonuria cases (P < 0.001). Over three-fourths of patients (75.6%) had a ketonuria duration of ≤2 hours in the Moderate group, 61.2% had a ketonuria duration of between 3 and 4 h in the Ketosis group, and most of the ketonuria cases resolved in the first stage of labor. As the degree of ketonuria progressed, we observed a significantly higher number of cases with fetal heart rate pattern III (FHR pattern III), meconium-stained amniotic fluid III (MSAF III), postpartum hemorrhages, prolonged labor, neonatal hypoglycemia, an umbilical cord arterial pH of <7.2, low Apgar scores, increased neonatal intensive care admissions, augmented forceps-assisted deliveries, and conversions to cesarean sections. The results showed that ketonuria is common during the intrapartum period and that the risk of adverse maternal and neonatal outcomes may increase when complicated with ketonuria.

Project description:BackgroundMaternal perception of decreased fetal movements is commonly used to assess fetal well-being. However, there are different opinions on whether healthcare professionals should encourage maternal observation of fetal movements, as researchers claim that raising awareness increases unnecessary interventions, without improving perinatal health. We aimed to investigate whether cesarean sections and labor induction increase by raising women's awareness of fetal movements through Mindfetalness. Further, we aimed to study perinatal health after implementing Mindfetalness in maternity care.MethodsIn a cluster randomized controlled trial, 67 maternity clinics were allocated to Mindfetalness or routine care. In the Mindfetalness group, midwives distributed a leaflet telling the women to focus on the character, strength and frequency of the fetal movements without counting each movement. The instruction was to do so for 15 min daily when the fetus was awake, from gestational week 28 until birth. In this sub-group analysis, we targeted women born in Sweden giving birth from 32 weeks' gestation. We applied the intention-to-treat principle.ResultsThe Mindfetalness group included 13,029 women and the Routine-care group 13,456 women. Women randomized to Mindfetalness had less cesarean sections (18.4% vs. 20.0%, RR 0.92, CI 0.87-0.97) and labor inductions (19.2% vs. 20.3%, RR 0.95, CI 0.90-0.99) compared to the women in the Routine-care group. Less babies were born small for gestational age (8.5% vs. 9.3%, RR 0.91, CI 0.85-0.99) in the Mindfetalness group. Women in the Mindfetalness group contacted healthcare due to decreased fetal movements to a higher extent than women in the Routine care group (7.8% vs. 4.3%, RR 1.79, CI 1.62-1.97). The differences remain after adjustment for potential confounders.ConclusionsRaising awareness about fetal movements through Mindfetalness decreased the rate of cesarean sections, labor inductions and small-for-gestational age babies.Trial registrationClinicalTrials.gov ( NCT02865759 ). Registered 12 August 2016, www.clinicaltrials.gov .

Project description:ImportanceFetal death during labor at term is a complication that is rarely studied in high-income countries. There is a need for large population-based studies to examine the rate of term intrapartum stillbirth in high-income countries and the factors associated with its occurrence.ObjectiveTo evaluate trends in term intrapartum stillbirth over time and to investigate the association between the trends and term intrapartum stillbirth risk factors from 1999 to 2018 in Norway.Design, setting, and participantsThis cohort study used data from the Medical Birth Registry of Norway from 1999 to 2018 to examine rates of term intrapartum stillbirth and risk factors associated with this event. A population of 1 021 268 term singleton pregnancies without congenital anomalies or antepartum stillbirths was included in analyses, which were performed from September 2022 to February 2023.ExposureThe main exposure variable was time, which was divided into four 5-year periods: 1999 to 2003, 2004 to 2008, 2009 to 2013, and 2014 to 2018.Main outcomes and measuresThe primary study outcome was term intrapartum stillbirth. Risk ratios were calculated, and multivariable logistic regression analyses were conducted to identify factors associated with secular trends of term intrapartum stillbirth.ResultsThe study population consisted of 1 021 268 term singleton births (maternal mean [SD] age, 29.72 [5.01] years; mean [SD] gestational age, 39.69 [1.27] weeks). During the study period, there were 95 term intrapartum stillbirths (0.09 per 1000 births). Maternal age, the proportion of individuals born in a country other than Norway, and the prevalence of gestational diabetes, labor induction, operative vaginal delivery, and previous cesarean delivery increased over the course of the study period. Conversely, the prevalence of infants large for gestational age, hypertensive disorder in pregnancy, and spontaneous vaginal delivery and the proportion of individuals who smoked decreased. The term intrapartum stillbirth rate decreased by 87% (95% CI, 68%-95%) from 0.15 per 1000 births in 1999 to 2008 to 0.02 per 1000 births in 2014 to 2018. Three in 4 term intrapartum stillbirths (70 of 95) occurred during intrapartum operative deliveries. The increased prevalence of older maternal age and obstetric risk factors were not associated with the variation in intrapartum stillbirth rates among the time periods. The prevalence of term intrapartum stillbirth was higher for individuals who gave birth in maternity units with fewer than 3000 annual births (adjusted odds ratio, 1.67; 95% CI, 1.07-2.61) than for those who gave birth in units with 3000 or more annual births.Conclusions and relevanceFindings of this study suggest that, despite increases in maternal and obstetric risk factors, term intrapartum stillbirth rates substantially decreased during the study period. Reasons for this decrease may be due to improvements in intrapartum care.

Project description:BackgroundIncreases in the proportion of the population with increased likelihood of cesarean section (CS) have been postulated as a driving force behind the rise in CS rates worldwide. The aim of the study was to assess if changes in selected maternal risk factors for CS are associated with changes in CS births from 1999 to 2016 in Norway.Methods and findingsThis national population-based registry study utilizes data from 1,055,006 births registered in the Norwegian Medical Birth Registry from 1999 to 2016. The following maternal risk factors for CS were included: nulliparous/≥35 years, multiparous/≥35 years, pregestational diabetes, gestational diabetes, hypertensive disorders, previous CS, assisted reproductive technology, and multiple births. The proportion of CS births in 1999 was used to predict the number of CS births in 2016. The observed and predicted numbers of CS births were compared to determine the number of excess CS births, before and after considering the selected risk factors, for all births, and for births stratified by 0, 1, or >1 of the selected risk factors. The proportion of CS births increased from 12.9% to 16.1% (+24.8%) during the study period. The proportion of births with 1 selected risk factor increased from 21.3% to 26.3% (+23.5%), while the proportion with >1 risk factor increased from 4.5% to 8.8% (+95.6%). Stratification by the presence of selected risk factors reduced the number of excess CS births observed in 2016 compared to 1999 by 67.9%. Study limitations include lack of access to other important maternal risk factors and only comparing the first and the last year of the study period.ConclusionsIn this study, we observed that after an initial increase, proportions of CS births remained stable from 2005 to 2016. Instead, both the size of the risk population and the mean number of risk factors per birth continued to increase. We observed a possible association between the increase in size of risk population and the additional CS births observed in 2016 compared to 1999. The increase in size of risk population and the stable CS rate from 2005 and onward may indicate consistent adherence to obstetric evidence-based practice in Norway.

Project description:OBJECTIVE:To estimate the contributions of patient and health care provider-hospital characteristics to the variation in the frequency of nulliparous, term, singleton, vertex cesarean delivery in a multi-institutional U.S. cohort. METHODS:We performed a secondary analysis of the multicenter Assessment of Perinatal Excellence cohort of 115,502 mother and neonatal pairs who were delivered at 25 hospitals between March 2008 and February 2011. Women met inclusion criteria if they were nulliparous and delivered a singleton in vertex presentation at term. Hospital ranks for nulliparous, term, singleton, vertex cesarean delivery frequency were determined after risk adjustment. The fraction of variation in nulliparous, term, singleton, vertex cesarean delivery frequency attributable to patient and health care provider-hospital characteristics was assessed using hierarchical logistic regression. RESULTS:Of the 115,502 deliveries in the initial cohort, 38,275 nulliparous, term, singleton, vertex deliveries met inclusion criteria. The median hospital nulliparous, term, singleton, vertex cesarean delivery frequency was 25.3% with a range from 15.0% to 35.2%. The majority of hospitals (16/25) changed rank quintiles after risk adjustment; overall the changes in rank were not statistically significant (P=.53). Patient characteristics accounted for 24% of the nulliparous, term, singleton, vertex cesarean delivery variation. The analyzed health care provider-hospital characteristics were not significantly associated with cesarean delivery frequency. CONCLUSION:Although patient characteristics accounted for some of the variation in nulliparous, term, singleton, vertex cesarean delivery frequency and accounting for case mix had implications for hospital cesarean delivery rankings, the majority of the variation was not explained by the characteristics evaluated. These findings emphasize the importance of continued efforts to understand aspects of obstetric care, including case mix, that contribute to cesarean delivery variation.

Dataset Information

Study protocol: the Labor Progression Study, LAPS - does the use of a dynamic progression guideline in labor reduce the rate of intrapartum cesarean sections in nulliparous women? A multicenter, cluster randomized trial in Norway.

Publications

Study protocol: the Labor Progression Study, LAPS - does the use of a dynamic progression guideline in labor reduce the rate of intrapartum cesarean sections in nulliparous women? A multicenter, cluster randomized trial in Norway.

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