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


METHODS
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.


CONCLUSIONS
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.
Berghella
Vincenzo
V
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
Figueroa
Dana
D
Szychowski
Jeff M
JM
Owen
John
J
Hankins
Gary D V
GD
Iams
Jay D
JD
Sheffield
Jeanne S
JS
Perez-Delboy
Annette
A
Wing
Deborah A
DA
Guzman
Edwin R
ER
D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D023802:Cerclage, Cervical; D054791:Cervical Length Measurement; D005260:Female; D005313:Fetal Death / Q000517:prevention & control; D006801:Humans; D006908:Hydroxyprogesterones / Q000627:therapeutic use*; D007231:Infant, Newborn; D016015:Logistic Models; D015999:Multivariate Analysis; D054238:Perinatal Mortality; D011247:Pregnancy; D047928:Premature Birth / Q000401:mortality / Q000517:prevention & control*; D011372:Progestins / Q000627:therapeutic use*; D016896:Treatment Outcome; D002581:Uterine Cervical Incompetence / Q000188:drug therapy* / Q000601:surgery; D055815:Young Adult
D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate