Yilmaz 2009.
| Methods | Study design: randomised controlled trial. Allocation generation: computer‐generated random number. Allocation concealment: opaque, sealed envelopes that were consecutively numbered. Blinding: patients and physicians blinded. Loss to follow‐up: Intervention: 10%. Control: 9%. |
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| Participants | Total number of participants randomised: 160. Inclusion criteria: primigravidae, 18‐30 years old, with gestational age 40+, healthy, with single fetus in vertex presentation, needing induction due to oligohydramnios, rupture of membranes or post‐term. Exclusion criteria: spontaneous labour, fetal weight > 4000 g, CPD, non‐reassuring CTG, allergy to meperidine or valethamate bromide, previous uterine surgery, active PV bleeding, placenta previa, use of analgesia prior to randomisation. |
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| Interventions | Intervention: 1. Meperidine 50 mg (1 mL) in 9 mL NaCl IVI between 4 and 6 cm dilatation. n = 53. 2. Valethamate bromide 16 mg (2 mL) IVI in 8 mL of NaCl between 4 and 6 cm dilatation. n = 53. Control: NaCl 10 mL IVI between 4 and 6 cm dilatation. n = 54. |
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| Outcomes | Primary outcomes: 1. Duration of first stage or labour (time from intervention to complete dilatation). 2. Duration of second stage. 3. Total duration of labour. Secondary outcomes: 1. Mode of delivery. 2. Cervical lacerations. 3. Adverse maternal and fetal events. |
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| Notes | Ethics: approval by Human Research Review Committee Location: Turkey. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers. |
| Allocation concealment (selection bias) | Low risk | Opaque, sealed and consecutively numbered envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants blinded, nurses not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants are accounted for, flow‐chart present. |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes have been reported. Primary outcomes: time to complete dilation, duration of second stage of labour, labour duration ‐ no missing outcome data. Secondary outcomes: mode of delivery, presence of cervical lacerations and adverse maternal and neonatal events ‐ no missing outcome data. |
| Other bias | Low risk | No other potential bias detected. Drug company sponsorship: no. |
CPD: cephalopelvic disproportion CTG: cardiotocography h: hour(s) HBB: hyoscine butyl‐bromide IM: intramuscular IMI: intramuscular injection IVI: intravenous injection IUGR: intrauterine growth restriction NaCl: sodium chloride PI: principal investigator PV bleeding: vaginal bleeding RCT: randomised controlled trial ROM: rupture of membranes SD: standard deviation