Qublan 2001.
| Study characteristics | ||
| Methods | Type of study: RCT Method of treatment allocation: random‐number table generated randomisation sequence Allocation concealment unclear. Stratification: none stated Placebo: no Sample size calculation: no Intention‐to‐treat analyses: yes Losses to follow‐up: no | |
| Participants | Location: 2 military hospitals in Jordan Eligibility criteria: women with singleton pregnancies and PROM Gestational age range: 27‐34 weeks Exclusion criteria: lethal congenital anomaly, fetal death, infection, expected delivery within 12 hours Total recruited: 139 women and infants; 72 women and infants in the treatment arm and 67 women and infants in the control arm | |
| Interventions | The treatment group received 4 doses of 6 mg dexamethasone IM 12 hours apart, repeated if women had not delivered after 1 week. The control group received expectant management. | |
| Outcomes | Maternal outcomes (chorioamnionitis, endometritis), fetal/neonatal outcomes (fetal death, neonatal death, RDS, IVH, proven neonatal infection while in NICU, necrotising enterocolitis, Apgar < 7) and health service outcome reported (length of neonatal hospitalisation) | |
| Notes | Study authors contacted for further information but no reply. Discrepancy in number of infants with necrotising enterocolitis in manuscript Study dates: January 1997‐February 1999 Funding: not stated Declarations of interest: not reported |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random‐number table generated randomisation sequence. |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel was not possible due to the nature of the comparison. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment was not described. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up or exclusions stated |
| Selective reporting (reporting bias) | Unclear risk | Discrepancy in number of infants with necrotising enterocolitis in manuscript |
| Other bias | Low risk | No indication of any other source of bias |