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A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method.

ABSTRACT: BACKGROUND:Maternal 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. METHODS:In 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. RESULTS:The 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. CONCLUSIONS:Raising awareness about fetal movements through Mindfetalness decreased the rate of cesarean sections, labor inductions and small-for-gestational age babies. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02865759 ). Registered 12 August 2016, www.clinicaltrials.gov .

SUBMITTER: Akselsson A

PROVIDER: S-EPMC7528254 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method.

Akselsson Anna A Lindgren Helena H Skokic Viktor V Rådestad Ingela I

BMC pregnancy and childbirth 20201001 1

<h4>Background</h4>Maternal 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 Min ...[more]

PMID: 32998708

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Project description:Background2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth.MethodsThis stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022.Findings37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23).InterpretationThe RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven.FundingChief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

Project description:BackgroundIn 2013, the stillbirth rate in the UK was 4.2 per 1000 live births, ranking 24th out of 49 high-income countries, with an annual rate of reduction of only 1.4% per year. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency the most common clinical finding. Maternal perception of reduced fetal movements (RFM) is associated with placental insufficiency and increased risk of subsequent stillbirth.This study will test the hypothesis that the introduction of a package of care to increase women's awareness of the need for prompt reporting of RFM and standardised management to identify fetal compromise with timely delivery in confirmed cases, will reduce the rate of stillbirth. Following the introduction of a similar intervention in Norway the odds of stillbirth fell by 30%, but the efficacy of this intervention (and possible adverse effects and implications for service delivery) has not been tested in a randomised trial.MethodsWe describe a stepped-wedge cluster trial design, in which participating hospitals in the UK and Ireland will be randomised to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from detailed routinely collected maternity data, allowing us to robustly test our hypothesis. The degree of implementation of the intervention will be assessed in each site. A nested qualitative study will examine the acceptability of the intervention to women and healthcare providers and identify process issues including barriers to implementation.Ethics and disseminationEthical approval was obtained from the Scotland A Research Ethics Committee (Ref 13/SS/0001) and from Research and Development offices in participating maternity units. The study started in February 2014 and delivery of the intervention completed in December 2016. Results of the study will be submitted for publication in peer-reviewed journals and disseminated to local investigating sites to inform education and care of women presenting with RFM.Trial registration numberwww.clinicaltrials.gov NCT01777022.VersionProtocol Version 4.2, 3 February 2017.

Project description:BACKGROUND:Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. METHODS/DESIGN:This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. DISCUSSION:Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. TRIAL REGISTRATION:ACTRN12614000291684. Registered 19 March 2014. VERSION:Protocol Version 6.1, February 2018.

Project description: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.

Dataset Information

A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method.

Publications

A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method.

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