Table 1.
Randomized double-blind placebo controlled trials of the efficacy of progesterone for the prevention of PTB (years 2003–2007)
| Authors (year) | Progest agent/dose/duration | GA @ initiation (week) | # of subjects
|
% preterm deliveries
|
||
|---|---|---|---|---|---|---|
| Progest | Placebo | Progest | Placebo | |||
| Meis et al104 (2003) | 17 OHP-C, weekly IM 250 mg. up to 36.9 wks | 16–20.9 singleton | 310 | 153a | <37 wk: 36.3
<35 wk: 20.6 <32 wk: 11.4 |
54.9
30.7 19.6 |
| da Fonseca et al103 (2003) | Natural micronized vaginal non-bioadhesive progest. suppositories, 100 mg daily, up to 34 wks | 24–34 singleton | 72 | 70 | <37 wk: 13.8
<34 wk: 2.8 |
28.5
18.6 |
| O’Brien et al106 (2007) | Natural micronized vaginal bioadhesive progest. gel, 90 mg daily, up to 36.9 wks | 18–22.9 singleton | 309 | 302 | ≤ 37 wk: 41.7
≤ 35 wk: 22.7 ≤ 32 wk: 10.0 ≤ 28 wk: 3.2 |
40.7
26.5 11.3 3.0 |
| de Fonseca et al108 (2007) | Natural micronized vaginal non-bioadhesive progest. capsule, 200 mg daily up to 33.9 wks | 20–25 singleton (~90%) and twin | 125 | 125b | <34 wk: 9.2 | 34.4 |
| Rouse et al107 (2007) | 17 OHP-C, weekly IM 250 mg, up to 35 wks | 16–20.9 twin | 325 | 330 | <37 wk: 69.5
<32 wk: 6.9 <27 wk: 8.0 |
70.3
14.5 6.1 |
a
Placebo used was castor oil.
b
Placebo used was safflower oil.
Abbreviations: Progest, progesterone; 17 OHP-C: 17 alpha hydroxyprogesterone caproate.