Pregnancy outcomes of women receiving compounded 17 α-hydroxyprogesterone caproate for prophylactic prevention of preterm birth 2004 to 2011
American Journal of Perinatology, 05/14/2012
Sibai BM et al. – Maternal characteristics and pregnancy outcomes were compared between study group and NICHD Network trial patients. Home nurse administration of compounded 17P is safe and effective.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.
- 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).