Progesterone n = 19 | Placebo n = 22 | p-value* | Median/Mean/Risk Difference (95% Confidence Interval)* | |
---|---|---|---|---|
Primary outcome | ||||
Median Gestational age at delivery (weeks and days) | 36+2 (IQR 7+4) Range 26+6 to 41+2 | 36+4 (IQR 8+0) Range 24+3 to 41+2 | 0.865 | −0+2 (−3+1 to 2+3) |
Mean Latency from randomization to delivery (days) | 44.5 (SD 35.6) Range 0 to 113 | 46.6 (SD 29.9) Range 2 to 116 | 0.841 | −2.1 (−22.8 to 18.6) |
Secondary outcomes | ||||
Maternal outcomes | ||||
Gestational age at delivery <37 weeks | 11 (57.9%) | 11 (50.0%) | 0.758 | 7.9% (−23.1% to 38.0%) |
Gestational age at delivery <35 weeks | 8 (42.1%) | 9 (40.9%) | >0.999 | 1.2% (−29.5% to 31.4%) |
Gestational age at delivery <34 weeks | 7 (36.8%) | 8 (36.4%) | >0.999 | 0.5% (−30.0% to 30.4%) |
Tocolytics at any time during this pregnancy | ||||
Yes | 14 (77.8%) | 16 (84.2%) | 0.693 | −6.4% (−36.3% to 26.3%) |
No | 4 (22.2%) | 3 (15.8%) | ||
Unknown | 1 | 3 | ||
PPROM | ||||
Yes | 3 (16.7%) | 4 (18.2%) | >0.999 | −1.5% (−32.0% to 28.8%) |
No | 15 (83.3%) | 18 (81.8%) | ||
Unknown | 1 | 0 | ||
Betamethasone treatment | ||||
Yes | 15 (93.8%) | 18 (94.7%) | >0.999 | −1.0% (−33.1% to 31.6%) |
No | 1 (6.3%) | 1 (5.3%) | ||
Unknown | 3 | 3 | ||
Mode of delivery | ||||
Vaginal | 9 (47.4%) | 16 (72.7%) | 0.493 | 14.1% (−16.5% to 43.2%) |
Operative vaginal | 3 (15.8%) | 1 (4.6%) | ||
Cesarean Section | 7 (36.8%) | 5 (22.7%) | ||
Delivery complications | ||||
None | 15 (83.3%) | 18 (90.0%) | 0.653 | 6.7% (−24.7% to 38.1%) |
Hypertension | 0 (0.0%) | 1 (5.0%) | ||
AP bleed | 0 (0.0%) | 1 (5.0%) | ||
Othera | 3 (16.7%) | 0 (0.0%) | ||
Unknown | 1 | 2 | ||
Infant outcomes | ||||
Median Birth weight (grams) | 2625 (IQR 1340) Range 750 to 3766 (missing = 1) | 2660 (IQR 1555) Range 670 to 3955 | 0.734 | −105 (−739 to 506) |
Adverse outcomes | 0.732 | 9.5% (−23.9% to 41.1%) | ||
One or more | 10 (66.7%) | 12 (57.1%) | ||
None | 5 (33.3%) | 9 (42.9%) | ||
Unknown | 4 | 1 | ||
Description of outcomes (could be more than one) | ||||
Stillbirth/neonatal death | 0 | 0 | ||
BPD | 0 | 3 | ||
IVH | 0 | 0 | ||
NEC | 0 | 1 | ||
RDS | 4 | 7 | ||
Apnea/bradycardia | 1 | 2 | ||
Jaundice/hyperbilirubinemia | 4 | 6 | ||
Suspected sepsis | 2 | 2 | ||
Transient tachypnea | 1 | 2 | ||
Otherb | 8 | 20 | ||
On ventilator | 0 | 4 | ||
Median Baby length of stay (days) | 6 (IQR 29) Range 0 to 86 (missing = 3) | 3 (IQR 38) Range 1 to 127 (missing = 4) | 0.903 | 0 (−15 to 10) |