| Methods |
Random allocation derived from a table of random numbers. Method of concealment not described. |
| Participants |
Women at or beyond 287 days of gestation, with a single fetus in cephalic presentation. Weight between 2500 g and 4500 g, AFI between 5 and 25 cm, reactive NST and uterine contractions less than one per 5 minutes. Exclusion: absent prenatal care, previous uterine surgery, medical or psychiatric illness or drug use. |
| Interventions |
Four groups:
1 No sweeping and placebo gel.
2 No sweeping and PGE2 gel.
3 Sweeping and placebo gel.
4 Sweeping and PGE2 gel. |
| Outcomes |
Interval from admission to delivery. Cesarean section and instrumental delivery, induction of labour, oxytocin augmentation, epidural analgesia, number of visits.
Apgar score, admission at neonatal intensive care unit, meconium stained liquor. |
| Notes |
Unequal number of women in the four groups, reasons not explained in the methods section. Exclusions after randomisation because of missing data (delivery outside the hospital): 7 women (0/28, 3/40, 1/51, 3/31 in groups 1 to 4, respectively). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
