Hydroxyprogesterone - 17 Alpha Hydroxyprogesterone Caproate


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17 ALPHA HYDROXYPROGESTERONE CAPROATE, (17P), PREVENTS PRETERM BIRTH IN WOMEN AT HIGH RISK

PAUL J. MEIS FOR THE NICHD MFMU NETWORK, BETHESDA MD

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 at 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

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