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Table 3 Other secondary trial outcomes

From: Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial

Outcome Metformin Placebo p value
Open label antiglycemic agenta 3/49 (6 %) 1/50 (2 %) 0.36
Nauseab 2/49 (4 %) 0/50 (0 %) 0.24
Vomitingb 1/48 (2 %) 0/50 (0 %) 0.49
Diarrheab 3/48 (6 %) 1/50 (2 %) 0.36
Mode of delivery
Spontaneous vertex delivery 19/52 (37 %) 10/51 (20 %) 0.16
Vacuum/Forceps delivery 4/52 (8 %) 5/51 (9.8 %)  
Cesarean delivery 29/52 (56 %) 36/51 (71 %)  
  n = 52 n = 51  
Estimated blood loss (ml) 300 [213–475] 300 [300–400] 0.80
  n = 48 n = 50  
VNRS SMBGc 9 [8-10] 9 [8-10] 0.46
VNRS Allocated Medicined 9 [1-10] 9 [1-10] 0.23
  n = 52 n = 51  
Birth weight (kg) 2.51 ± 0.61 2.66 ± 0.56 0.21
  n = 52 n = 51  
Apgar Score at 1 minute 9 [9] 9 [9] 0.68
Apgar Score at 5 minutes 10 [10] 10 [10] 0.23
  n = 46 n = 50  
Umbilical arterial blood pH 7.30 [7.24–7.35] 7.32 [7.25–7.35] 0.43
  n = 45 n = 47  
Umbilical arterial base deficit 2.1 [0.7–4.4] 1.8 [0.8–3.7] 0.52
SCN/NICUe Admission 18/52 (35 %) 14/51 (28 %) 0.43
Indication for NICU admission
 Prematurity 6 (33.3 %) 4 (28.6 %) 0.59
Transient tachypnea of newborn 5 (27.8 %) 2 (14.3 %)  
Presumed sepsis 2 (11.1 %) 4 (28.6 %)  
Othersf 5 (27.8 %) 4 (28.6 %)  
  1. Data expressed as number (%), mean ± standard deviation, median [interquartile range] and number (%). Analyses by Student t test for comparisons of means, Mann Whitney U test for comparison of non-parametric or ordinal data, Chi square test for categorical datasets (Fisher’s exact test for 2 × 2 categorical datasets if any cell < 5). All tests 2-sided
  2. aMetformin or insulin if BSP > 11 mmol/L or at providers’ discretion for severe hyperglycemia
  3. bAny reported episode recorded during the 3-day trial
  4. cVisual numerical rating scale (scored 0–10, higher score greater satisfaction) for experience with self-monitoring of capillary blood glucose
  5. d Visual numerical rating scale (scored 0–10, higher score greater satisfaction) for experience with allocated medicine
  6. eSpecial care nursery/Neonatal intensive care unit
  7. f Others: neonatal jaundice 5, respiratory distress syndrome 2, duodenal atresia 1 and suspected hypoxic ischemic encephalopathy 1
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