Randomized Trial of Labor Induction in Women 35 Years of Age or Older

Jordan Alava, Mercer University College of Pharmacy

A review of 96 population-based studies concluded that advanced maternal age was associated with a 65% increase in the chance of stillbirth.  The review also states that the odds of stillbirth increased with increasing age, doubling for women aged 40 or older.  [1]

Per the Centers for Disease Control and Prevention (CDC), approximately 1% of all pregnancies are stillbirths, which translates to about 24,000 stillborn babies in the United States each year.  The CDC also reports that the number of stillbirths each year is greater than 10 times that amount of deaths due to Sudden Infant Death Syndrome (SIDS).  [2]

Title: Randomized Trial of Labor Induction in Women 35 Years of Age or Older
Design Multicenter, randomized, controlled; N= 619
Objective To ascertain whether induction of labor at 39 weeks of gestation as compared with expectant management has an effect on the rate of cesarean delivery
Study Groups Labor induction (n= 305); expectant management (n= 314)
Methods Primigravid women who were 35 years of age or older were randomly assigned to labor induction between 39 weeks 0 days and 39 weeks 6 days of gestation or to expectant management.
Duration August 2012 to March 2015
Primary Outcome Measure Cesarean section delivery
Baseline Characteristics Baseline characteristics were similar between groups.  Mean age was 37 years and about 27% of patients had a body mass index of ≥30.  Over 90% of participants were white and 16% of them had a medical history of disease.
Results   Induction group (n= 305) Expectant-management group (n= 314) Relative Risk (95% CI) p value
Cesarean section, No. (%) 98 (32) 103 (33) 0.99 (0.87–1.14) 0.92

 

Abbreviations: confidence interval (CI)
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: primary postpartum hemorrhage (26.8%), neonatal sepsis (0.006%), neonatal jaundice (0.003%), neonatal intensive care unit admission (0.006%)
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Among women of advanced maternal age, induction of labor at 39 weeks of gestation as compared with expectant management had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.

This study demonstrated that induction of labor had no impact on the amount of cesarean deliveries when compared to expectant management.  The limitations of this study were its lack of ethnic diversity among participants and the exclusion of women who had given birth previously.  Both of these factors suggest that the data cannot be used to interpret how induction of labor affects the rate of cesarean delivery in all advanced maternal aged women.  Further research is needed that samples a wider range of ethnicities and includes both nulliparous and multiparous women to address these issues.

References

  1. Flenady V, Koopmans L, Middleton P, et al. Major risk factors for stillbirth in high-income countries: a systematic review and meta-analysis. Lancet. 2011;377(9774):1331-40.
  2. Facts about stillbirth. Centers for Disease Control and Prevention. 2015. Available at: http://www.cdc.gov/ncbddd/stillbirth/facts.html. Accessed March 18, 2016.
  3. Walker KF, Bugg GJ, Macpherson M, et al. Randomized Trial of Labor Induction in Women 35 Years of Age or Older. N Engl J Med. 2016;374(9):813-22.
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