Because reduced fetal movement is associated with higher stillbirth risk, asking women to be alert to RFM and report it immediately has emerged as a potential intervention to prevent stillbirth. But a large, randomized trial of one reporting and management protocol showed no reduction in stillbirths, only a rise in C-sections and preterm inductions.
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Jane E. Norman, MD, of the University of Edinburgh, and her colleagues published results from a trial in the Lancet, in which 409,175 pregnant women (mean age, 30 years) across 33 hospitals in the United Kingdom and Ireland received either standard care or the experimental RFM care intervention before delivery. Women were seen during an experimental 3-month period, in which all were treated according to the protocol, or the 3-month control period that preceded it. A 2-month washout period occurred between allocations as institutions adapted to the study protocol.
The trial intervention consisted of training clinical staff on the implications and management of RFM, distributing written information on RFM to women at about 20 weeks’ gestation, and a management protocol aimed at quick action following a report of RFM at 24 or more weeks’ gestation. The protocol included cardiotocography within 2 hours of presentation followed by measurement of liquor volume and a growth scan, along with umbilical artery Doppler where available. Delivery was recommended for women at 37 or more weeks’ gestation with estimated fetal weight below the 10th centile, abdominal circumference below the 10th centile, a low liquor volume, an abnormal cardiotocograph, or recurrent RFM.
Incidence of stillbirth at or beyond 24 weeks was 4.40 per 1,000 births during the control period and 4.06 per 1,000 births in the intervention period (adjusted odds ratio, 0.90; 95% confidence interval, 0.75-1.07; P = .23), the researchers found. No differences were seen when stratifying for different gestational ages.
Meanwhile, induction of labor before 39 weeks was more frequent during intervention period at 40% of deliveries, compared with 34% during the control time (P less than .0001), and at term (41% vs. 36%; P = .0015). C-section was higher in the intervention group at 28% versus 26% (P = .0001). Neonatal ICU stays were not more common but were likely to be longer in the intervention period, with stays of 2 days or longer occurring in 6.7% of deliveries versus 6.2% (P =.0001).
The investigators concluded that their protocol, in its current design, was not effective and could not be recommended because of the significant increase in interventions.
Dr. Norman and her colleagues wrote that the findings would “reignite the controversy about the efficacy of RFM awareness to reduce stillbirth and the underlying mechanisms linking RFM and stillbirth.” However, the results do not mean that RFM is a sign of inevitable fetal death or that there is no role for RFM awareness as a stillbirth-prevention strategy. Other large trials testing RFM-based interventions are still underway, they noted.
“Further research to identify better predictive tests for stillbirth [to enable targeting of the only current treatment of earlier delivery] is urgently needed,” the investigators added.
In a related study also published in the Lancet, Lucy K. Smith, PhD, of the University of Leicester (England), and her colleagues reported that the real burden of stillbirth in Europe, while much lower than in the developing world, is still a third higher than reported using the current international cutoff established by the World Health Organization.
Dr. Smith and her colleagues examined national cohort data from 19 European countries between 2004 and 2015 for pregnancy outcomes from 22 completed weeks’ gestation. In 2015, they found more than 9,000 stillbirths occurred among more than 25 million births, and 3,022 of these (32%) occurred between 22 and 28 weeks’ gestation.
The WHO officially defines stillbirth as any baby born without life at 28 weeks or beyond, although it recommends that countries collect data on fetal death from 22 weeks. However, discrepancies between and even within countries in reporting laws and their implementation “inhibit reliable international comparisons” at those earlier gestational ages, Dr. Smith and her colleagues wrote.
The researchers, pooling data from the 19 countries, found that the stillbirth rate at 24-28 weeks’ gestation declined from 0.97 per 1,000 births (95% CI, 0.80-1.14) to 0.70 per 1,000 births (95% CI, 0.57-0.82) between 2004 and 2015, a reduction of 25% (risk ratio; 0.75; 95% CI, 0.65-0.85).
“The decrease of 25% in stillbirths at 24 weeks to less than 28 weeks is very similar to that seen globally for stillbirths of 28 weeks of gestation [25.5% worldwide and 24.5% in developed regions] and above for a similar time period of 2000-2015, suggesting consistent improvements over time in the reduction of stillbirths from 24 completed weeks of gestation,” the researchers wrote in their analysis.
Data from France, Spain, and Cyprus was not included in the analysis as these countries did not collect fetal death reports for the gestational periods in the study. Also, for a few countries in the study, late terminations of pregnancy could not be distinguished from spontaneous fetal death.
“The consistency in reporting of births over time at 24 weeks to less than 28 weeks of gestation and the similarity of reduction in the rate of stillbirth over time to births at 28 completed weeks of gestation and above suggest that stillbirths at 24 weeks to less than 28 weeks of gestation can be routinely included in rates of stillbirth for international comparisons from now on,” at least in high-income countries, the investigators wrote.
The study by Norman et al. was funded by the Scottish government, Tommy’s Health Center, and Sands, a U.K. stillbirth charity. The article presents research funded in part by the National Institute for Health Research. Several investigators, including the lead author, reported financial support from these entities. One author reported salary from National Health Service Lothian. All other authors reported no relevant financial disclosures. The study by Smith et al. was funded by the European Union and National Institute for Health Research. Dr. Smith received funding from a National Institute for Health Research Career Development Fellowship. All other authors reported no financial conflicts of interest.
SOURCES: Norman JE et al. Lancet. 2018;392:1629-38; Smith LK et al. Lancet. 2018;392:1639-46.