NeoNotes Journal Club
Andrew B. Kairalla MD, Editor
4-005 | Additional Comments | Previous Article | Next Article | List of Articles | Submit Comments | Index | FSN Home Page
17P Prevents
Preterm Birth
17 Alpha Hydroxyprogesterone Caproate Prevents Recurrent Preterm Birth.
Meis PJ for the NICHD MFMU Network.
Presented at the 23rd Annual Meeting of the Society for
Maternal-Fetal Medicine in
Objective: This trail was conducted to confirm a benefit for 17 alpha hydroxyprogesterone (17P) therapy in preventing recurrent preterm birth.
Study Design: Women with a documented history of a previous spontaneous preterm birth < 37 weeks EGA were enrolled 19 centers between 16 and 20 weeks gestation and randomly assigned in a double blinded fashion (in a 2 to 1 ratio) to weekly injections of 17P or placebo. The injections were continued to 36 weeks gestation.
Results: 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, <35, and <32 weeks gestation (See Table).
|
|
Placebo |
17P |
RR |
p |
|
N |
153 |
306 |
|
|
|
<37 wks |
55% |
36% |
0.66 |
0.0001 |
|
<35 wks |
31% |
21% |
0.67 |
0.0165 |
|
<32 wks |
20% |
11% |
0.58 |
0.0180 |
Conclusion: Treatment with 17P provided significant and powerful protection against recurrent preterm birth in women at high risk.
Comment:
The use of 17P has the potential of making a dramatic impact on the incidence
of recurrent preterm deliveries. One disadvantage is the need for weekly
injections starting at 16-20 weeks. I
also have concerns about possible fetal side effects (short-term and
long-term). I hope that the 19 centers involved in this study plan to do
long-term neuro-developmental follow up on the babies delivered to study
patients. It will take years to adequately address the long-term safety
concerns of this practice. ABK.
Additional Comments: You may add your own comments to the discussion of this topic by selecting : Submit Comments.