Trial reportBMC pregnancy and childbirth2017
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.
Trial report in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02221427 (The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Diagnostic accuracy of the partograph alert and action lines to predict adverse birth outcomes: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2019Pooled it
- The effect of Zhang's guideline vs the WHO partograph on childbirth experience measured by the Childbirth Experience Questionnaire in the Labor Progression Study (LaPS): A cluster randomized trial.Acta obstetricia et gynecologica Scandinavica · 2022Trial
- Parturition in Mammals: Animal Models, Pain and Distress.Animals : an open access journal from MDPI · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundThe 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. METHODS/
designA 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. DISCUSSION: 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.
trial registrationClinicaltrials, NCT02221427.
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