Table 1.
Characteristics of randomized trials comparing initial tocolysis vs. no tocolysis or placebo in women with PPROM
| Author, year (reference) | Methods, n | Inclusion criteria | Intervention | Antibiotics / Steroids | Primary outcome | Main result |
|---|---|---|---|---|---|---|
| Christensen, 1980 [29] | RCT, n = 30 | Singletons, 28–36 wks, with contractions | Ritodrine vs placebo, until 35 wks | Only for urogenital colonization / not specified | Not pre-specified | Significant reduction of deliveries within 24 h, no difference at 48 h |
| Levy, 1985 [30] | RCT, n = 42 | Singletons, 25–34 wks, no contractions | Ritodrine vs placebo, until labor | Only if cesarean section / no | Latency period | Significant prolonged mean latency period for treated women |
| Dunlop, 1986 [31] | RCT, n = 48 | Singletons, 26–34 wks, no uterine contractions |
A: no ritodrine, no cephalexin B: ritodrine, cephalexin C: ritodrine, no cephalexin D: no ritodrine, cephalexin |
Only for groups B and D / systematic | Type of labor, mode of delivery, neonatal and maternal outcomes including admission to birth interval | No advantage to the newborn |
| Garite, 1987 [32] | RCT, n = 79 | Singletons, 25–30 wks, with or without contractions | Ritodrine vs placebo, until 31 wks | Only if cesarean section / no | Time interval from PPROM to birth | No difference |
| Weiner, 1988 [33] | RT, n = 75 (+ 34 excluded from analyses) | Singletons, up to 34 wks, with contractions | Ritodrine, terbutaline or magnesium sulfate vs bedrest, no clear duration | Only for urogenital colonization / no | Not clearly stated | No difference |
| Matsuda, 1993 [34] | RT, n = 81 | Singletons, 23–34 wks, no contractions | Ritodrine vs bedrest, no clear duration | Only for treated women / not specified | Prolongation of pregnancy | Prolongation for more than 72 h was greater for treated women |
| How, 1998 [35] | RCT, n = 145 | Singletons and twins, 24–34 wks, not in labor | Magnesium sulfate (treatment initiated only if contractions occurred) vs no tocolysis | Systematic / systematic (weekly) | Not clearly stated | No difference in latency duration, no difference in neonatal outcomes |
| Ehsanipoor, 2011 [36] | RCT, n = 47 | Singletons, 24–31 w, no contractions | Indomethacin vs placebo, for 48 h | Systematic / systematic | Delivery within 48 h | No difference |
| Nijman, 2016 [37] | RCT, n = 50 | Singletons and twins, 24–33 wks, no contractions | Nifedipine vs placebo, until the onset of labor (up to 18 days or 34 wks) | According to local guidelines / Systematic | Composite of poor neonatal outcome | No difference |
h hours, RCT randomized controlled trial, RT randomized trial, wks weeks