Abstract
Objective To examine pregnancy outcomes of women receiving weekly compounded 17 α-hydroxyprogesterone
caproate (17P) injections through a home nursing program compared with those reported
in a multicenter trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Network.
Methods The study sample was comprised of patients receiving compounded 17P through a home
nurse administration care management program. Included were women with current singleton
gestation and prior spontaneous preterm birth (SPTB) initiating 17P between 16 and
20 weeks. Maternal characteristics and pregnancy outcomes were compared between study
group and NICHD Network trial patients.
Results Women (n = 5493) received a mean of 16.9 ± 4.0 injections. Of the 92,700 injections, 98.4%
were administered within the recommended 5- to 9-day interval. Recurrent SPTB occurred
in 28.3%. The overall rate of SPTB at <37 weeks was similar for black and nonblack
women (p = 0.592). Within black or nonblack groups, preterm birth rates at <37 weeks were
similar regardless of gestational age at start of 17P (p = 0.894 and p = 0.374, respectively). These results were similar to those reported in the multicenter
trial. Fetal and neonatal death occurred in 0.8% (46/5493). No significant difference
was observed in rate of fetal or neonatal death by gestational age at initiation of
17P (p = 0.478).
Conclusion Home nurse administration of compounded 17P is safe and effective.
Keywords
17 alpha-hydroxyprogesterone caproate - compounded 17P - Makena - preterm birth prevention
- safety
