Methods | RCT 2-arm parallel group design. | |
Participants | 120 women attending an antenatal clinic in a hospital in France, 1990-91 Inclusion criteria: termpregnancy scheduled for induction (range of indications), Bishop score < 4 Exclusion criteria: malpresentation, ruptured membranes, multiple pregnancy, > 1 previous CS or known medical condition |
|
Interventions | Intervention group: active tablets mifepristone 200 mg. All women received a box with 2 tablets, the first to be taken on the morning of day 1 and the second on the morning of day 2 Comparison group: placebo tablets. Same regimen as intervention group IOL scheduled for 4 days after intervention, women reported to the hospital each day over the 4 day study period and were asked to report drug reactions, pain, bleeding or contractions |
|
Outcomes | Labour within 4-day study period, other induction agents required, duration of labour, mode of birth, Apgar score < 7 at 5 min | |
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Tablets were supplied by pharmacy according to a “balanced randomisation list”. Block size 4 |
Allocation concealment? | Yes | Small block size might mean that allocation order could potentially be anticipated in advance but the drug packs were described as being of similar appearance |
Blinding? Women |
Yes | Described as a double-blind study. |
Blinding? Clinical staff |
Yes | Placebo described as being of similar appearance. |
Blinding? Outcome assessor |
Yes | |
Incomplete outcome data addressed? All outcomes |
Unclear | 120 women were randomised but 8 were excluded from the results because of a deterioration in their condition within 12 hours of the first pill (3 in the mifepristone group and 5 in the placebo group) |
Free of other bias? | Unclear | Additional induction agents were used for some women so labour and other outcomes may be affected by co-interventions |