Haghighi 2005.
Methods | Randomised by sequential use of opaque, sealed envelopes numbered using random‐number tables. Double blinding implied. No power calculation. No intention‐to‐treat analysis. | |
Participants | Iran. 150 pregnant women in preterm labour (defined as more than 8 uterine contractions per hr that lasted longer than 30 seconds and progressive cervical dilatation z1 cm during a 3.5‐h observation) between 33 and 36 weeks with a singleton pregnancy. | |
Interventions | 1. Isosorbide dinitrate sublingual tablet 5 mg, repeated every 30 minutes up to 40 mg or stop of contractions. 10 mg 1 hour after halt of contractions and every 6 hrs for 48 hrs (n = 75). 2. Placebo (n = 75). |
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Outcomes | Primary outcome was preterm birth. Secondary outcomes were adverse effects and Apgar scores. | |
Notes | Both groups first administered 50 mg i.v. of meperidine in 500 mL of Ringer solution over 30 minutes, followed by 100 mL per hr of the same for 3 hrs. No information on whether women got steroids and/or antibiotic therapy. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐number tables. |
Allocation concealment (selection bias) | Low risk | Envelopes sequentially numbered, sealed and opaque. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded, unclear re personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether assessors blinded or not. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the 81 women randomised to isosorbide dinitrate group, 6 were excluded for reasons that may have related to treatment allocation (hypotension). |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit a judgement. |
Other bias | Unclear risk | Little information on participant characteristics. |