17 Alpha-Hydroxyprogesterone Caproate (17P) Prevents Preterm Birth in Women at High Risk
OBJECTIVE
Although early small studies suggested a benefit for 17P therapy in preventing preterm birth, no large rigorous trial has confirmed these data. The current study was undertaken to answer this question.
STUDY DESIGN
Women with a documented history of a previous spontaneous preterm birth at less that 37 weeks gestational age were enrolled at 19 Centers at 16 to 20 weeks gestation and randomly assigned by a central data center using a 2 to 1 ratio to weekly injections of 17P or to a placebo injection, with treatment continuing to 36 weeks gestation.
RESULTS
The predominant race of the subjects was African-American, (59%). Mean gestational age at birth of the qualifying delivery was 30.7 weeks. Baseline characteristics of the treatment group, n=306, and the placebo group, n=153, were similar. Treatment with 17P significantly reduced the risk of preterm birth at <37 weeks, <35 weeks and <32 weeks gestation. Treatment with 17P was equally effective in African American and non-African American subjects.
CONCLUSIONS
Weekly injections of 17P can provide a significant and powerful protection to prevent recurrent preterm birth in women at high risk.
|
Placebo |
17P |
Relative risk |
Conf. Int. |
p |
|
n |
153 |
306 |
|
|
|
|
<37 wks |
54.9% |
36.3% |
0.66 |
(0.54-0.81) |
0.0001 |
|
<35 wks |
30.7% |
20.6% |
0.67 |
(0.498-0.93) |
0.0165 |
|
<32 wks |
19.6% |
11.4% |
0.58 |
(0.37-0.91) |
0.0180 |
Source: New England Journal of Medicine PAUL J. MEIS FOR THE NICHD MFMU NETWORK, BETHESDA MD