Reduction of late stillbirth with the introduction of fetal movement information and guidelines – a clinical quality improvement

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  Background Women experiencing decreased fetal movements (DFM) are at increased risk of adverse outcomes, including stillbirth. Fourteen delivery units in Norway registered all cases of DFM in a population-based quality assessment. We found that
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  BioMed   Central Page 1 of 10 (page number not for citation purposes) BMC Pregnancy and Childbirth Open Access Research article Reduction of late stillbirth with the introduction of fetal movement information and guidelines – a clinical quality improvement JulieVictoria HolmTveit* 1,2 , EliSaastad 2,3 , BabillStray-Pedersen 1 , PerEBørdahl 4,5 , VickiFlenady  6 , RuthFretts 7  and J FrederikFrøen* 2,7  Address: 1 Division of Obstetrics and Gynecology, and Centre for Perinatal Research, Rikshospitalet University Hospital, University of Oslo, Medical Faculty, Norway, 2 Norwegian Institute of Public Health, Division of Epidemiology, Oslo, Norway, 3  Akershus University College, and University of Oslo, Medical faculty, Norway, 4 Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway, 5 Institute for Clinical Medicine, Section for Gynaecology and Obstetrics, University of Bergen, Norway, 6 Department of Obstetrics and Gynecology, University of Queensland, Mater Mothers' Hospital, South Brisbane, Australia and 7 Brigham and Women's Hospital, Div. of Maternal-Fetal Medicine, Harvard Medical School, Boston, MA, USA Email: JulieVictoria HolmTveit*-julievh@medisin.uio.no; EliSaastad-eli.saastad@fhi.no; BabillStray-Pedersen-babill.stray-pedersen@medisin.uio.no; PerEBørdahl-per.e.bordahl@helse-bergen.no; VickiFlenady-vicki.flenady@mater.org.au; RuthFretts-rfretts@vmed.org; J FrederikFrøen*-frederik.froen@fhi.no* Corresponding authors Abstract Background: Women experiencing decreased fetal movements (DFM) are at increased risk of adverse outcomes, including stillbirth. Fourteen delivery units in Norway registered all cases of DFM in a population-based quality assessment. We found that information to women andmanagement of DFM varied significantly between hospitals. We intended to examine two cohortsof women with DFM before and during two consensus-based interventions aiming to improve carethrough: 1) written information to women about fetal activity and DFM, including an invitation tomonitor fetal movements, 2) guidelines for management of DFM for health-care professionals. Methods: All singleton third trimester pregnancies presenting with a perception of DFM wereregistered, and outcomes collected independently at all 14 hospitals. The quality assessment periodincluded April 2005 through October 2005, and the two interventions were implemented fromNovember 2005 through March 2007. The baseline versus intervention cohorts included: 19,407versus 46,143 births and 1215 versus 3038 women with DFM, respectively. Results: Reports of DFM did not increase during the intervention. The stillbirth rate amongwomen with DFM fell during the intervention: 4.2% vs. 2.4%, (OR 0.51 95% CI 0.32–0.81), and 3.0/1000 versus 2.0/1000 in the overall study population (OR 0.67 95% CI 0.48–0.93). There was noincrease in the rates of preterm births, fetal growth restriction, transfers to neonatal care or severeneonatal depression among women with DFM during the intervention. The use of ultrasound inmanagement increased, while additional follow up visits and admissions for induction were reduced. Conclusion: Improved management of DFM and uniform information to women is associated withfewer stillbirths. Published: 22 July 2009 BMC Pregnancy and Childbirth  2009, 9 :32doi:10.1186/1471-2393-9-32Received: 25 February 2009Accepted: 22 July 2009This article is available from: http://www.biomedcentral.com/1471-2393/9/32© 2009 Tveit et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the srcinal work is properly cited.  BMC Pregnancy and Childbirth   2009, 9 :32http://www.biomedcentral.com/1471-2393/9/32Page 2 of 10 (page number not for citation purposes) Background Maternal perception of fetal movements (FM) is a univer-sally implemented self-screening, administered and inter-preted individually by all pregnant women, with or  without guidance from health care professionals [1].Maternal reporting of decreased fetal movements (DFM)is a frequent reason for unplanned health consultationsthrough the third trimester ranging between 4%–16% in various populations [1-3] and 5% in a previous report [2]. Pregnancies affected by DFM are at increased risk of adverse outcome such as fetal growth restriction (FGR),preterm birth and fetal death [4-9].  There is no universally accepted methodology for assess-ing DFM. Every method has its limitations and a "goldstandard" is difficult to define. Maternal perception of FMarises first and foremost as a result of pressure against body-wall structures, and thus the mother's perceptionreflects gross FM or limb movements [10,11]. The propor-tion of movements perceived by the mother and docu-mented during ultrasound monitoring at the same timeranges from 37% to 88% [12]. A common factor in thesestudies is that the mother is lying down and focusing onfetal activity. This is the only situation in which we know that maternal perception and objective measures of FMare strongly correlated with objective measures of fetalactivity. Outside such a setting, both the actual frequency of movements as well as the mother's ability to perceivethem are influenced by factors such as maternal position[13], activity and exercise [14], anxiety [15], stress [16], blood sugar [17], smoking [18], placenta localization [10], and obesity [19]. Parity has not been found to affect maternal perception of FM in the third trimester [10], but multiparous might be able to perceive FM earlier in preg-nancy than primiparous [20]. There are significant diurnal variations in normal fetal activity, which changes gradu-ally with gestation [10,20]. Among the attempts to define DFM, a variety of methodsof FM counting with different alarm limits have been pub-lished [1,6,7]. Among these, the rule of "ten movements  within 2 hours" [21]. This is the only definition of DFMbased on focused maternal counting which has been bothdeveloped and tested as a screening tool in a total popula-tion, and currently the definition of DFM recommendedby the American Academy of Pediatrics and the AmericanCollege of Obstetricians and Gynecologists if maternalmovement counting is performed [22]. Other definitionsof DFM have mostly been based on counting throughboth rest and activity and have little evidence in support of their association with actual fetal activity. The most important clinical understanding of DFM is still themother's own perception of a decrease [1,23-26]. There are no universally accepted guidelines for the man-agement of DFM [7,12]. Although several studies have presented guidelines including non-stress test (NST),ultrasound examination and Doppler [2,3,5,7,22,27], most of these recommendations are based on limited evi-dence, as we have reviewed elsewhere [7,12].  We intended to examine two cohorts of women with DFMbefore and during a quality improvement intervention by implementing guidelines for management of DFM anduniform information on fetal activity to women. Methods  Women with singleton pregnancies of at least 28 weeksgestation or more who reported a concern for DFM (either by spontaneous reporting or upon questioning), were reg-istered prospectively for quality-assurance purposes at 14delivery units in eastern Norway and the city of Bergen. The registrations were a part of the international collabo-ration, Fetal Movement Intervention Assessment (Femina) [2]. Recurrent visits for DFM in already regis-tered pregnancies were excluded as we intended to report the number of women newly reporting DFM. Data from women with a stillborn infant were obtained separately,to ensure completeness of mortality data, but stillbirthsnot initially identified by DFM were subsequently excluded, as were pregnancies with a gestational age under 28 weeks and multiple pregnancies (figure 1). To ensureunbiased registrations for quality-assurance of clinicalpractice at the individual hospital, maternal consent wasnot sought. The study was approved by The RegionalCommittees for Medical Research Ethics and PersonalData Act and advised by The Norwegian Data Inspector-ate. Data collection  The registration period included 7 months of baselineobservation followed by 17 months of intervention: from April 1, 2005 to March 31, 2007. In Norway, almost allpregnant women attend the antenatal program which isfree of charge and covered by the public health-care serv-ices. The Norwegian antenatal care program is following contemporary guidelines composed by the National Insti-tute of Clinical Excellence [28]. The community midwivesand general practitioners are in charge of the antenatalprogram, and without the possibility to perform an NST or ultrasound examinations locally, they usually refer theconcerned mothers to the nearby hospital with a mater-nity ward. Hence, the pregnant women in Norway typi-cally contact maternity wards directly with any acuteconcerns for DFM. There are no private delivery wards inNorway. Women fulfilling the inclusion criteria were reg-istered prospectively by the caregiver at the time the woman presented to the hospital. Pregnancy outcome were collected independently after delivery from the med-ical files by study coordinator at each hospital. Data wereanonymized and submitted to the study-coordinating centre. DFM was defined as any woman presenting with  BMC Pregnancy and Childbirth   2009, 9 :32http://www.biomedcentral.com/1471-2393/9/32Page 3 of 10 (page number not for citation purposes) concerns for DFM, irrespective of whether this was basedon her subjective opinion or it emerged during an antena-tal visit for other reasons. In addition to the registrationsby our study protocol, the numbers of births and still-births from our population were obtained from the Med-ical Birth Registry in Norway to assess overall trends instillbirth, for the most updated period available: April2005 to December 2006. Guideline development Our observations of pregnancies with DFM prior to theintervention identified significant differences in manage-ment between hospitals – none had provided the women with written information – and there were indications of co-variation between management and pregnancy out-comes [2]. Almost all hospitals would perform an NST,about half performed an ultrasound scanning, and somecarried out an umbilical artery Doppler examinations [2]. The risk of adverse outcomes increased with the severity (perceived absence of DFM) and duration of DFM. Unde-sirable behavior was frequent, with one-third of the women did not present before an absence of FM was per-ceived: one-quarter of these women waited for more that 24 hours [2]. An initial survey of all 55 birth clinics inNorway found a wide range of definitions of DFM used toinform women, varying from three kicks per hour to anabsence of more than 24 hours [29]. Among the fourteenparticipating clinics, the women received a wide range of advice in terms of normal frequency of FM: varying from25 kicks per hour to 3 kicks per 24 hours [30]. With this in mind, a systematic review of all currently pub-lished literature was undertaken to determine the optimalmanagement for women with DFM. A group of expertstogether with Chairs of midwifery and obstetrics of allparticipating hospitals developed a best- practice- andconsensus-based approach to the best-practice manage-ment of DFM and the information provided to pregnant  women. In our own quality assessment of care prior to theintervention, NST and ultrasound examination were Trial profile Figure 1Trial profile . Trial profile of total births and reports of decreased fetal movements before and during the intervention *All deaths, irrespective of how they were initially identified, were included in analyses of mortality in the total population. Total population n = 65,550 Total births prior to the intervention, Total births during the intervention, n=19,407 n=46,143 Reports of DFM prospectively registered in singleton third trimester pregnancies prior to the intervention, n = 1370 Reports of DFM prospectively registered in singleton third trimester pregnancies during the intervention, n = 3534 Excluded Recurrent visits, gestational age < 28 weeks, fetal deaths not initially identified by DFM and multiple pregnancies, n = 128* Excluded Recurrent visits, gestational age < 28 weeks, fetal deaths not initially identified by DFM and multiple pregnancies, n = 439* Baseline cohortIntervention cohortReports of DFM prospective registered in singleton third trimester pregnancies, n = 1215 Reports of DFM prospective registered in singleton third trimester pregnancies, n = 3038 Lost to follow-up, n=27 (2.2%) Lost to follow-up, n=57 (1.9%)  BMC Pregnancy and Childbirth   2009, 9 :32http://www.biomedcentral.com/1471-2393/9/32Page 4 of 10 (page number not for citation purposes) found to be the most useful tools for fetal surveillance inDFM, while an umbilical artery Doppler examinationfailed to add significant information among 3014 cases of DFM. Ultrasound scanning was, by comparison, the most important tool, being the source of information in 86.2%of cases where abnormalities were detected [12]. In brief,our implemented guidelines recommended: a standardclinical evaluation for all women reporting DFM, an NST,and an ultrasound scan to quantify FM, amniotic fluid volume, and fetal anatomy and growth. A mother present-ing with a concern of DFM was to be examined within two2 hours if absence of FM was suspected, otherwise within12 hours (guidelines published in detail) [12]. Information for women  We developed a brochure of information that aimed toincrease maternal awareness and vigilance to significant decreases in fetal activity, and to aid health-promoting behavior. This was provided as a part of the routine infor-mation given to women at the standard ultrasound assess-ment at 17–19 weeks of pregnancy (to which 98% of thepopulation adhere). In addition to Norwegian, the bro-chure was available in Somali, Urdu, English, Turkish,and Arabic. The brochure included certain "rules of thumb" about fetal activity (additional files 1, 2, 3, 4, 5and 6). The primary indicator of DFM was defined as her perception of a major and lasting reduction in the normalactivity of her baby. In some situations the woman wasadvised to contact health-professionals for further exami-nations: 1) never to wait to the next day if the baby did not kick one day or, 2) if the baby kicked less and less in thecourse of a day/days, or 3) if she felt less than ten FM in 2hours at a time of the day when the baby was usually active, and she perceived this as a reduction. As a guide tohelp the women to identify DFM, an invitation to use akick chart was included. The informational brochure onFM for the mothers and new guidelines for health-careprofessionals were implemented in November 2005 in allhospitals included in the Femina trial. End points  The main outcome measures were all antepartum, intra-partum and neonatal death in the delivery room (i.e., thedeath occurred immediately after completion of delivery)from 28 completed weeks of gestation in women who were previously registered as having one or more episodesof DFM. As there was only one neonatal death, all deathsare called "stillbirths" in the following. The number of births and third trimester stillbirths (singleton and multi-ples) in the Norwegian population from the years 1999–2004 ranges between 56,374 to 59,927 births, and 2.9/1000 to 3.9/1000 stillbirths, respectively. However, as anadditional 0.2/1000 to 0.4/1000 of stillbirths during thesame period are registered as of unknown gestational age,this may be underestimates [31]. Secondary outcomes for  women with DFM were: severe neonatal depression,defined as Apgar score of < 3 at 5 minutes postpartum;symptoms of multisystem organ failure and pH < 7 in theumbilical artery or fetal capillary scalp, if obtained; pre-term birth (28° – 36 6  weeks); FGR (< 10th percentile of birthweight adjusted for gender and mother's height, weight, parity, and ethnicity) [32]; fetal heart rate tracingsjudged clinically as nonreassuring and leading to inter- vention in labor; oligohydramnios defined as an amniotic fluid index of < 5 cm or at < 2.5th percentile; polyhydram-nios defined as an amniotic fluid index of > 25 cm or at >97.5th percentile; investigations undertaken for reducedFM; and examinations of DFM resulting in immediateadmission for induction of labor or caesarean section.Outcomes related to maternal behavior were: the number of women waiting more than 24 hours with an absence of FM or more than 48 hours with a decrease of FM beforecontacting health-care professionals. Statistical analysis  All statistical analysis were performed with SPSS version15.0. (SPSS Chicago, IL, USA) using cross tabulations, with χ 2 tests and logistic regressions to find crude (unad-justed) and adjusted odds ratios (OR) with 95% confi-dence intervals (CI). The level of statistical significance was set at p < 0.05. In the multivariate analysis, all out-comes were adjusted for potential confounding factors –such as maternal age, body mass index (BMI), smoking habits, parity, and ethnicity – due to prior knowledge of their impact on pregnancy outcomes and health-promot-ing behavior. Results Number of cases included in the baseline and interven-tion cohorts are described in figure 1. The number of women presenting with DFM remainedunchanged during intervention at 6.3% versus 6.6% (OR 1.05; 95% CI 0.98–1.12, p = 0.19), respectively. The rateof unplanned repeat visits for DFM was consistently very low, but increased from 0.3% to 0.5%, p = 0.002. The stillbirth rates among women with DFM were reducedby almost 50% (OR 0.51; 95% CI 0.32–0.81, p = 0.004))from 4.2% (n = 50) to 2.4% (n = 73) during the interven-tion. Stillbirth rates among women in the entire cohort  were reduced by one third from 3.0/1000 to 2.0/1000(OR 0.67; 95% CI 0.48–0.93, p = 0.02). Independent datafrom the Medical Birth Registry in Norway, confirmedthat the stillbirth rate in our total cohort of births wascomparable to the rest of Norway in the baseline observa-tion (OR 1.06; 95% CI 0.70–1.65, p = 0.73), and signifi-cantly lower during the intervention period (OR 0.64;95% CI 0.47–0.87, p = 0.005). The intervention was fol-lowed prospectively with statistical process control charts  BMC Pregnancy and Childbirth   2009, 9 :32http://www.biomedcentral.com/1471-2393/9/32Page 5 of 10 (page number not for citation purposes)  which indicated a significant change in mortality after 7months of intervention (arrow in figure 2), and no monthduring the intervention with a mortality exceeding thepre-intervention mean (figure 2). There was no increase insecondary outcomes such as preterm births, FGR, severeneonatal depression or transfers to neonatal care among  women with DFM during the intervention period (table1). Among those with DFM, fewer women with a perceivedabsence of FM waited more than 24 hours, or a perceiveddecrease for more than 48 hours, before contacting health-care professionals during the intervention. There were no changes over time in the population in potentialconfounding factors as maternal age, BMI, smoking hab-its, parity or ethnicity (table 2). At consultations for DFM the use of ultrasound increased while there were no differences in frequency of umbilicalartery Doppler examinations. The complete detection rateof FGR following consultations for DFM and subsequent follow up was not captured, only diagnoses set at the ini-tial consultation. This detection rate rose by 83% from2.4% to 4.4%, p = 0.020 in term (> 36 weeks) pregnan- Table 1: Outcomes of the quality improvement intervention, N = 4253 Univariate*Multivariate*Baseline % (n)Intervention % (n)Crude OR95% CIP ValueAdjusted OR†95% CIP Value MATERNAL BEHAVIOR IN DFM Consultation rate of DFM 6.3 (1215)6.6 (3038)1.050.98–1.120.19Not available Time to contact > 24 hours in absent fetal movements 24 (99)18 (201)0.700.53–0.920.010.730.53–1.000.05 Time to contact ≥  48 hours in DFM 54 (415)49 (897)0.830.70–0.980.030.730.60–0.900.002 E XAMINATIONS AT CONSULTATION FOR DFMUsed CTG 96 (1155)98 (2929)1.671.16–2.410.0061.460.92–2.300.11 Used ultrasound 86 (1040)94 (2764)2.502.02–3.12< 0.0012.642.02–3.45< 0.001 Used Doppler  44 (532)47 (1415)1.151.00–1.300.041.120.96–1.330.20 C ONSEQUENCES OF THE EXAMINATION FOR DFM No follow up 63 (716)69 (1980)1.341.16–1.55< 0.0011.361.14–1.61< 0.001 Admissions 14 (158)11 (300)0.730.59–0.900.0030.710.55–0.910.006 Admissions for induction 7.0 (80)4.9 (141)0.690.52–0.920.010.680–49–0.960.03 Admissions for emergency section 1.8 (21)1.2 (35)0.660.38–1.140.140.730.40–1.590.43 P REGNANCY OUTCOMES Non-reassuring heart rate tracings in labor (DFM) 11 (130)14 (398)1.271.03–1.570.031.230.96–1.570.11 Severe neonatal depression (DFM) 1.7 (19)1.1 (30)0.640.39–1.030.070.550.29–1.040.07 Admitted to neonatal care (DFM) 4.4 (52)4.5 (131)1.020.73–1.410.911.020.69–1.520.92 Preterm births 28 ° - 36 6  weeks (DFM) 12 (145)10 (169)0.790.62–1.000.050.790.60–1.050.10 FGR < 10 percent (DFM) 14 (168)13.5 (391)0.930.77–1.130.480.970.77–1.230.82 Stillbirths (DFM) 4.2 (50)2.4 (73)0.580.41–0.840.0040.510.32–0.810.004 Normally formed stillbirths (DFM) 3.9 (46)2.2 (65)0.570.39–0.830.0040.500.31–0.810.005 Stillbirths (rate in total population) 3.0/10002.0/10000.670.48–0.930.02Not available Normally formed stillbirths (rate in total population) 2.8/10001.8/10000.600.42–0.850.004Not available* Univariate and multivariate logistic regression showing crude (unadjusted) and adjusted odds ratios (OR) with their 95% confidence intervals (CI). † OR adjusted for maternal weight, age, parity, smoking habits and ethnicity (considered as potential confounding factors). DFM: cases of decreased fetal movements.
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