DALLAS – A hospital-wide intervention designed to prevent stillbirth by focusing on reduced fetal movement failed to do so – but did result in significant increases in labor induction and cesarean sections.
After the interventions was implemented, hospitals achieved a stillbirth rate of 4 per 1,000 – not significantly different than the 4.4 per 1,000 rate in the controls, Jane Norman, MD, reported at the meeting sponsored by the Society for Maternal-Fetal Medicine. On the other hand, the risk of a C-section increased by 9% and the risk of a labor induction by 8%, said Prof. Norman of the University of Edinburgh.
Michele G Sullivan/Frontline Medical News
Dr. Jane Norman
The results are disappointing, but consistent with most of the literature on this topic, she said.
“There is very good evidence that, if you ask women to count kicks, it doesn’t prevent stillbirth,” said Dr. Norman, referring to a 2015 Cochrane review. That paper, which examined five studies comprising more than 71,000 women, found that rates of stillbirth were similar between those who employed kick counts and those who did not.
Still, said Dr. Norman, there is evidence that stillbirth often is preceded by a period of reduced fetal movement. And a 2009 quality improvement project conducted in Oslo has driven enthusiasm for the idea of implementing some form of maternal and provider awareness of this area of obstetric care.
Stillbirth rates fell about 2% after the participating hospitals provided written information to women about fetal activity and reduced fetal movement, including an invitation to monitor fetal movements and formalized clinical guidelines for management of reduced fetal movement.
“There is a huge interest in the United Kingdom right now in using reduced fetal movement as an alert to act on to prevent stillbirth,” Dr. Norman said. “The National Health Service has recommended that we talk with women and clinicians about reduced fetal movement,” and try to incorporate it into clinical care.
Dr. Norman and her team wanted to emulate the Oslo experience, with a target of a 30% reduction in stillbirth rate.
The AFFIRM trial employed a clinical management guideline and patient education handout to raise awareness of reduced fetal movement as a trigger to investigate fetal well-being. The study used hospital records from 37 institutions in the United Kingdom and Ireland, which sequentially implemented the package. Hospitals were grouped into eight clusters. The trial began in January 2014. The first cluster began the intervention in mid-March; a new cluster came online every 3 months thereafter, until April 2016. Each cluster used its own baseline data as control.
The leaflet educated women about what fetal movements should feel like in all stages of pregnancy and what to expect from normal fetal movement. It encouraged them to report any lessening or cessation of fetal movement to their health care provider without delay.
The clinical guideline was matched to different gestational stages, but generally advocated cardiotocography and scans to estimate amniotic fluid volume and fetal size in cases of reduced movement with a low threshold for early delivery if there were abnormal findings at 37 weeks or later.
The final sample comprised 385,582 births, with 157,692 in the control period and 227,860 in the intervention period. The mean age of women was 30 years; 50% were white, 50% were overweight or obese, and 15% smoked. About 40% were nulliparous.
In the control arm, there were 691 stillbirths at 24 weeks’ gestational age or older (4.4/1,000). In the intervention arm, there were 921 events (4.06/1,000). The 10% risk reduction was not statistically significant.
The investigators also examined stillbirths occurring at 22 weeks or older, 28 weeks or older, and 37 weeks or older. Again, there were no significant between-group differences. Nor was there a difference in the perinatal mortality rate (0.68% vs. 0.62%).
There were, however, differences in interventions. The risk of a C-section increased by 5% (25.5% vs. 28.5%; adjusted odds ratio, 1.05), and the risk of induction by 9% (33.6% vs. 39.8%; AOR, 1.09). Most of the induction risk was driven by an 11% increase in induction risk at 39 weeks or older. The team also found a 5% increase in the chance of an elective delivery at 39 weeks or older (45.2% vs. 52.4%; AOR, 1.05)
There was a corresponding significant 10% decrease in the chance of spontaneous vaginal delivery (59.8% vs. 57.4%; AOR, 0.90).
Although there was no overall increase in the risk of a neonatal ICU admission, there was a significant 12% increase in the risk of a neonatal ICU admission of at least 48 hours (6.2% vs. 6.7%; AOR, 1.12). There were no other significant differences in neonatal outcomes (gestational age, size at birth, preterm delivery).
“We also looked at the potential impact if we implemented this intervention on a population of 10,000 pregnancies,” Dr. Norman said. “We would have 5 fewer stillbirths – but potentially anywhere from 11 fewer to 3 more. However, we would have 162 more cesarean deliveries and 108 more inductions.”
The AFFIRM trial was sponsored by the University of Edinburgh and the National Health Service. Dr. Norman had no financial disclosures.