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. 2014 May 8;2014(5):CD002860. doi: 10.1002/14651858.CD002860.pub2

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).
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.