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Randomized Controlled Trial
. 2010 Apr;202(4):351.e1-6.
doi: 10.1016/j.ajog.2010.02.019.

17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length

Vincenzo Berghella  1 , Dana Figueroa, Jeff M Szychowski, John Owen, Gary D V Hankins, Jay D Iams, Jeanne S Sheffield, Annette Perez-Delboy, Deborah A Wing, Edwin R Guzman; Vaginal Ultrasound Trial Consortium
Collaborators, Affiliations
Randomized Controlled Trial

17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length

Vincenzo Berghella et al. Am J Obstet Gynecol. 2010 Apr.

Abstract

Objective: We sought to evaluate 17-alpha-hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25 mm.

Study design: We conducted planned secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored randomized trial evaluating cerclage for women with singleton gestations, prior SPTB (17-33 6/7 weeks), and CL <25 mm between 16-22 6/7 weeks. Women were stratified at randomization to intent to use or not use 17P. The effect of 17P was analyzed separately for cerclage and no-cerclage groups. Primary outcome was PTB <35 weeks.

Results: In 300 women, 17P had no effect on PTB <35 weeks in either cerclage (P = .64) or no-cerclage (P = .51) groups. Only PTB <24 weeks (odds ratio, 0.08) and perinatal death (odds ratio, 0.14) were significantly lower for those with 17P in the no-cerclage group.

Conclusion: 17P had no additional benefit for prevention of PTB in women who had prior SPTB and got ultrasound-indicated cerclage for CL <25 mm. In women who did not get cerclage, 17P reduced previable birth and perinatal mortality.

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Figures

Figure 1
Figure 1
Time to delivery for women with and without progesterone use, randomized to cerclage (p=0.639).
Figure 2
Figure 2
Time to delivery for women with and without progesterone use, randomized to no cerclage (p=0.694)
See this image and copyright information in PMC

References

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