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5: Foley or Misoprostol for the Management of Induction (The ‘FOR MOMI’ trial): A four-arm randomized clinical trial

      Objective

      Induction of labor occurs in over 20% of women, yet there is no clear evidence demonstrating which induction method achieves the shortest labor. The use of combined agents to decrease labor length is an understudied, novel approach to shortening the time to delivery. Our objective was to evaluate the difference in time to delivery among four different induction methods, including two combination methods.

      Study Design

      A four-arm randomized clinical trial was conducted from May 2013-June 2015 comparing the use of: Misoprostol/Cervical foley (MF) concurrently, foley/Pitocin concurrently (FP), misoprostol alone (M), and foley alone (F). Randomization was stratified by parity. Labor management was standardized among participants. Term (≥37 weeks) singletons with intact membranes undergoing an induction with bishop score ≤6 were included. Our primary outcome was median [IQR] time to delivery and secondary outcome was cesarean delivery (CD) rate. Kruskal-Wallis, Pearson chi-square and Cox survival analyses with intent-to-treat principles were performed.

      Results

      492 women were randomized. Both combined methods (MF, FP) had a significantly shorter time to delivery (hours) than individual methods (M, F): (MF: 13.1 [9.1-18.3], FP: 14.5 [9.3-20.0], M: 17.6 [12-26.7], F: 17.7 [12.6-24.9], p=0.0001), see Figure. When adjusting for parity and mode of delivery, women induced with MF delivered 2.5 times faster than women who received M (Hazard ratio (HR): 2.5 (95%CI: 1.9-3.3), p<0.0001) and 2 times faster than women who received F (HR: 2.0 (95%CI: 1.6-2.6), p<0.0001). Results were similar when FP was compared to M and to F. There was no difference in time to delivery between MF and FP (p=0.2). CD rates were similar (MF: 27.6%, FP: 30.4%, Mo: 24.0%, Fo: 28.5%, p=0.7). A non-significant increase in neonatal morbidity was noted for the groups with a longer labor (MF: 0.8%, FP: 0.8%, M: 3.3%, F: 2.4%, p=0.4).

      Conclusion

      This randomized trial is one of the first of its kind to compare four different induction methods in a head-to-head trial. We found that combination induction methods resulted in delivery in half the amount of time as single agents with no difference in CD rates. Therefore, combined methods should be used for induction to achieve the shortest delivery time.
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