Behrad 2003.
Methods | Randomised controlled trial. | |
Participants |
Setting: Imam Reza’s Hospital, Iran. Participants: women (n = 100; 50 in the low‐dose group, 50 in the high‐dose group) between 24‐35 weeks' gestation with spontaneous preterm labour. Singleton and twin pregnancies were included. Definition of preterm labour: uterine contractions of more than 4 contractions per 20 minutes plus 1 of: cervical dilatation of at least 1 cm but less than 5 cm diameter, cervical effacement ≥ 80%, and/or progressive cervical dilatation and effacement. Exclusion criteria: higher‐order multiple gestations, rupture of membranes, non‐reassuring fetal assessment (abnormalities of the fetal heart rate pattern), evidence of intrauterine infection (temperature ≥ 38°C, leucocytosis, uterine tenderness, malodorous discharge), vaginal bleeding, patients with a history of diabetes mellitus, myasthenia gravis, any other neuromuscular diseases, impaired renal function (serum creatinine > 1.2 mg/dL), hypotension (mean arterial pressure < 70 mm Hg), maternal bradycardia (heart rate < 60 beats per minute), atrioventricular block, inability or refusal to provide informed consent. |
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Interventions | All women
Low‐dose group
High‐dose group
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Outcomes | Primary
Secondary
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Notes | Mean age of women: 23.8 ± 5.2 years in the low‐dose group; 24 ± 4.4 years in the high‐dose group. Twin gestations: 3/50 in the low‐dose group; 1/50 in the high‐dose group. Approval for this study was granted from the institutional review board of the University of Mashhad Medical Sciences. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned by computer‐generated number allocation. |
Allocation concealment (selection bias) | Low risk | Consecutively numbered opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details were given regarding blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details were given regarding blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up were reported. |
Selective reporting (reporting bias) | Low risk | No obvious risk of selecting reporting. |
Other bias | Low risk | No obvious risk of other bias. |