Table 1 Demographics of women and pregnancy outcomes in the study (excluding the withdrawals)
From: A randomised feasibility tolerability study of aminophylline for the prevention of preterm labour
SoC and aminophylline treatment (n = 30) | SoC (n=-29) | |||||||
|---|---|---|---|---|---|---|---|---|
*Age (years) | 36 ±4.0 | 33 ±5.1 | ||||||
*BMI | 24.5+-6.1 | 24.0 ±5.0 | ||||||
Smoking status | 0 | 0 | ||||||
*GA at baseline | 16.6 weeks ±2.2 | 15.4±2.7 | ||||||
Preterm birth risk factors | ||||||||
Short cervix in pregnancy | 0 | 2 (6.9%) | ||||||
Second trimester loss | 11 (36.7%) | 8 (27.6%) | ||||||
Spontaneous PTB in prev pregnancy | 14 (46.7%) | 14 (48.3%) | ||||||
MTOP second trimester | 1 (3.3%) | 0 | ||||||
Cervical treatment | 3 (10%) | 2 (6.9%) | ||||||
Cervical suture in previous pregnancy | 3 (10%) | 2 (6.9%) | ||||||
Ethnicity | ||||||||
Black (British, African, Caribbean) | 4 (13.3%) | 2 (6.9%) | ||||||
Indian | 3 (10%) | 1 (3.4%) | ||||||
Asian | 2 (6.7%) | 0 | ||||||
Middle eastern | 1 (3.3%) | |||||||
White | 8 (26.7%) | 10 (34.5%) | ||||||
Other/mixed | 5 (16.7%) | |||||||
Cervical suture during pregnancy | ||||||||
History indicated suture | 9 (30%) | 9 (31%) | ||||||
Ultrasound indicated cervical suture | 12 (40%) | 9 (31%) | ||||||
Transabdominal suture | 1 | 0 | ||||||
Maternal outcomes | ||||||||
Blood loss at birth | 425mls±394.9mls | 400mls±260.0mls | ||||||
GDM | 4 (13.3%) | 3 (10.3%) | ||||||
PET | 0 | 2(6.9%) | ||||||
Fetal outcomes | ||||||||
Admission to NICU | 5 (16.7%) | 3 (10.3%) | ||||||
Extreme Prematurity (< 26 weeks) | 0 | 1 (3.4%) | ||||||
26 weeks to 31 weeks | 1 (3.3%) | 0 | ||||||
32 weeks to 36 weeks | 4 (13.3%) | 4 (13.8%) | ||||||
Fetal abnormality | 1 (3.3%) | 2 (6.9%) | ||||||
*Length of latency of pregnancy (weeks) | 11.07±9.06 | 8.36±7.22 | ||||||
Side effect and tolerability profile | ||||||||
Aδ | Bε | Cγ | Dλ | Aδ | Bε | Cγ | Dλ | |
No of women | 24 | 20 | ||||||
Stomach upset | 3 (12.5%) | 21 (87.5%) | 20 (100%) | |||||
Diarrhoea | 4 (16.7%) | 1 (4.2%) | 19 (79.2%) | 1 (5%) | 19 (95%) | |||
Restlessness | 5 (20.8%) | 5 (20.8%) | 16 (66.7%) | 1 (5%) | 19 (95%) | |||
Headaches | 3 (12.5%) | 3(12.5%) | 18 (75%) | 2 (10%) | 18 (90%) | |||
Increased heart rate | 1 (4.2%) | 7 (29.2%) | 4 (16.7%) | 12 (50%) | 1 (5%) | 19 (95%) | ||
Skin rashes | 1 (4.2%) | 1 (4.2%) | 1 (4.2%) | 21 (87.5%) | 20 (100%) | |||
Other** | Mood swings n = 1 (4.2%) Dry mouth n = 1 (4.2%) Occasional dizziness and nausea n = 1 (4.2%) | Severe constipation n = 1 (5%) Depression and anxiety n = 2 (10%) | ||||||