Asgharnia 2002.
| Methods | Randomised controlled trial. | |
| Participants | 120 women in preterm labour between 24‐32 weeks' gestation with intact membranes and cervical dilation ≥ 2 cm. Exclusion criteria: PROM, complete cervical dilatation, severe haemorrhage, chorioamnionitis, high‐order multiple pregnancy (≥ triplets), fetal or placental abnormality or sensitivity to tocolytic drugs. |
|
| Interventions | COX group: indomethacin. 25 mg every 6 h (p.o.) up to maximum of 4 doses. Control group: MgSO4. Bolus dose of 4 g (i.v.) followed by 2 g/h (i.v.) given in 5% dextrose at 10‐25 µg/min (i.v.). Both groups: antibiotics as required and 5 mg dexamethasone every 12 h up to 4 doses. |
|
| Outcomes | Gestational age, mode of delivery, frequency of uterine contractions, dilatation and effacement and delivery delay. | |
| Notes | This paper was published in a non‐English language and has been translated for the purpose of this review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unable to determine how randomisation was performed. |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated, but there is no mention of simultaneous placebo treatment to adjust for differences in drug administration and it is likely that participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not stated, but there is no mention of simultaneous placebo treatment to adjust for differences in drug administration and it is likely that participants and personnel were not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised women were included in reporting. |
| Selective reporting (reporting bias) | Unclear risk | Unable to determine. |
| Other bias | Unclear risk | Unable to determine. |