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Andrew B. Kairalla MD, Editor

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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 San Francisco , Feb 3-8, 2003 .

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).

Table: Rates of Preterm Birth

 

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.

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