Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.
OBJECTIVE
To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.


METHODS
We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks.


RESULTS
One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks.


CONCLUSIONS
Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00099164


METHODS
I.
Caritis
Steve N
SN
Departments of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, PA 15213, USA. scaritis@mail.magee.edu
Rouse
Dwight J
DJ
Peaceman
Alan M
AM
Sciscione
Anthony
A
Momirova
Valerija
V
Spong
Catherine Y
CY
Iams
Jay D
JD
Wapner
Ronald J
RJ
Varner
Michael
M
Carpenter
Marshall
M
Lo
Julie
J
Thorp
John
J
Mercer
Brian M
BM
Sorokin
Yoram
Y
Harper
Margaret
M
Ramin
Susan
S
Anderson
Garland
G
D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D005260:Female; D006801:Humans; D006908:Hydroxyprogesterones / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011372:Progestins / Q000008:administration & dosage*; D012306:Risk; D017211:Treatment Failure; D014310:Triplets
D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate