Table 1.
Pregnancy and neonatal outcomes and sociodemographic characteristics of 57 mothers and their children who participated in Triple P follow‐up study and underwent BSID‐III assessment at 2 years of age, according to whether mothers were randomized to progesterone or placebo in Triple P trial
| Parameter | Progesterone (n = 28) | Placebo (n = 29) | P |
|---|---|---|---|
| Maternal characteristics | |||
| Age at randomization (years) | 31 (26–34) | 31 (29–34) | 0.46 |
| Nulliparous | 22 (79) | 18 (62) | 0.17 |
| Parental education* | 0.94 | ||
| High | 17 (61) | 18/28 (64) | |
| Middle | 5 (18) | 5/28 (18) | |
| Low | 6 (21) | 5/28 (18) | |
| White European | 22 (79) | 22 (76) | 0.81 |
| Infant characteristics at 2 years | |||
| Living in two‐parent family† | 25 (89) | 26/27 (96) | 0.51 |
| First‐born child | 22 (79) | 16/27 (59) | 0.12 |
| Dutch main language spoken at home | 26 (93) | 21/27 (78) | 0.11 |
| Bilingual | 7 (25) | 9/27 (33) | 0.50 |
| Breastfed for first 6 months‡ | 6/27 (22) | 9/27 (33) | 0.36 |
| Use of day care | 19 (68) | 18/27 (67) | 0.32 |
| Pregnancy outcome | |||
| Corticosteroids during pregnancy | 5 (18) | 5 (17) | 0.95 |
| PPROM | 4 (14) | 3 (10) | 0.71 |
| Complied with treatment§ | 20 (71) | 15/28 (54) | 0.21 |
| Neonatal outcome | |||
| Male gender | 19 (68) | 13 (45) | 0.08 |
| Composite adverse neonatal outcome¶ | 0 (0) | 2 (7) | 0.49 |
| Admission to NICU | 0 (0) | 5 (17) | 0.05 |
| GA at birth (weeks) | 38 + 6 (37 + 1 to 40 + 2) | 38 + 5 (37 + 6 to 40 + 1) | 0.82 |
| GA at birth < 32 weeks | 0 (0) | 3 (10) | 0.24 |
| GA at birth < 34 weeks | 2 (7) | 3 (10) | 1.00 |
| GA at birth < 37 weeks** | 5 (18) | 4 (14) | 0.73 |
| Birth weight (g) | 3013 (2603–3506) | 3360 (2915–3755) | 0.13 |
| Birth weight < 2500 g | 5 (18) | 4 (14) | 0.73 |
| Birth weight < 1500 g | 0 (0) | 2 (7) | 0.49 |
Data are given as median (interquartile range), n (%) or n/N (%).
Parental education: ‘low level’ (< 6 total years postelementary schooling) if at least one parent had a low level of education (but not if one parent had a high level); ‘middle level’ (6–8 total years postelementary schooling) if both parents had middle level of education; ‘high level’ (> 8 total years of postelementary schooling) if at least one parent was highly educated.
Two biological parents or one biological and one non‐biological parent.
Breastfeeding exclusively or in combination with formula for at least 6 months.
Used ≥ 80% of study medication.
Composite adverse neonatal outcome until 10 weeks after expected date of delivery, containing following components: respiratory distress syndrome, bronchopulmonary dysplasia, intracerebral hemorrhage > Grade II, necrotizing enterocolitis > Stage 1, proven sepsis and death before discharge.
Total number of children born < 37 weeks, i.e. includes children born < 34 weeks and < 32 weeks.
BSID‐III, Bayley Scales of Infant and Toddler Development, third edition; GA, gestational age; NICU, neonatal intensive care unit; PPROM, preterm prelabor rupture of membranes.