Lin 2009.
Methods | Randomised, unblinded, controlled trial. | |
Participants | 45 women with spontaneous preterm labour (duration of contractions 30 sec or more at a rate of ≥ 4/min, cervical dilation of 0‐3 cm and cervical effacement of ≥ 50%) at 24‐33 weeks' gestation. Exclusion criteria: multiple pregnancy (> twins), ruptured membranes, major vaginal bleeding (continuous vaginal bleeding or bleeding volume > 100 mL); pre‐eclampsia or hypertension (blood pressure > 140/90 mmHg), temperature > 37.5°C, urinary tract infection, fetal placental/amniotic abnormalities (e.g. major fetal anomalies, chorioamnionitis, polyhydramnios, fetal growth restriction or placenta praevia), serious maternal disease (e.g. cardiovascular disease, hyperthyroidism, diabetes, pheochromocytoma or asthma), contraindications to the use of betamimetics, alcohol or drug abuse, exposure to NSAID tocolytic drugs < 12 hr of study entry, hypersensitivity to any component of the study drugs and participation in an clinical trial < 1 month. |
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Interventions | ORA group: atosiban. A bolus dose (6.75 mg in 0.9 mL saline, i.v.) followed by infusion at 18 mg/h (300 µg/min) for 3 h and then 6 mg/h (100 µg/min) for 15 h. Control group: ritodrine. Initial infusion of 20 mL/h (66.6 µg/min, i.v.) and increased by 10 mL/h (33.3 µg/min) every 10‐30 min, until the desirable uterine response (uterine quiescence < 4 contractions/h) was obtained. Both atosiban and ritodrine was administered for maximum 18 h during first treatment. |
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Outcomes | Compare the tocolytic efficacy and safety profile of atosiban and ritodrine in an Asian population. Monitoring of adverse events, particularly tachycardia. Primary endpoint: to compare the proportion of women who did not deliver and did not receive an alternative tocolytic therapy after 7 days of treatment. Secondary endpoints: proportion of women who did not deliver after 2 days of treatment and did not require an alternative tocolytic. Other parameter measured: frequency of uterine contractions, gestational age at delivery, birthweight, maternal and fetal deaths and early drug discontinuation with/without alternative tocolytic treatment. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Women were computer‐randomized into two groups." Unable to determine how randomisation was performed. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | There was no blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women were included in the intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported as expected. |
Other bias | Low risk | None apparent. |