Rezk 2014.
| Methods | 2‐arm RCT | |
| Participants | Describe setting: Egypt Inclusion criteria: the study was conducted on 80 healthy pregnant women with previous 1 lower segment CS at 37 weeks and beyond, with a BS of ≤ 6, intact membranes, reactive non‐stress test, normal umbilical arterial Doppler indices, absence of labour and willingness of women to participate in the study. The indications for the induction of labour were pregnancy‐induced hypertension, oligohydramnios, intrauterine growth restrictions and controlled diabetes mellitus Exclusion criteria: women with intrauterine fetal death, twins pregnancy, polyhydramnios, placenta previa, severe anaemia, severe hypertension, uncontrolled diabetes, coagulopathy and any contraindication for the labour induction were excluded from the study |
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| Interventions | Experimental intervention: intracervical Foley catheter was inserted, inflated and placed on traction. Under aseptic conditions, with the women lying in the lithotomy position, the cervix was assessed and Foley catheter No. 14‐16 Fr was inserted into the endocervical canal, beyond the internal os and the balloon was inflated with 50‐60 mL of normal saline. The catheter was strapped to the thigh with gentle traction. The catheter was checked for its position and the traction at 3‐6 h intervals. The catheter was either removed at 12 h or expelled spontaneously and it was checked whether the BS had improved or whether a spontaneous rupture of the membranes had occurred. Total number randomised: n = 40 Comparison intervention: women received moistened 1 tablet of isosorbide mononitrate 40 mg (Monomak, October Pharma, Egypt) inserted into the posterior fornix of the vagina once. Total number randomised: n = 40 Women were examined regularly at 3 h, 6 h, 9 h, 12 h and 24 h after starting the method of induction to evaluate the change in BS. Vital signs were monitored every 30 min. AROM was performed for all women when their cervical dilatation reached 3‐4 cm and IV oxytocin infusion was started if there was no efficient uterine contractions. An oxytocin infusion was started at 2 mU/min and increased in increments of 1‐2 mU/min at 15‐30 min intervals as needed to achieve adequate uterine contraction pattern (≥ 200 MVU). Opiate and epidural analgesia was given on the woman’s request and at the discretion of the obstetrician. Continuous CTG was done during delivery and the modified WHO partograph was followed up for the labour management) |
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| Outcomes | Primary outcome measures included changes in BS, time from initiation till the onset of labour, the induction to delivery interval, the mode of delivery and the length of the second and third stages of labour. Maternal adverse effects, acceptability and neonatal outcome (Apgar score at 5 min, neonatal weight and admission to neonatal intensive care unit) were recorded as secondary outcomes. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation in 1:1 ratio was carried out using computer‐generated simple random tables |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind the study participants from knowledge of which intervention a participant received because methods were clearly different |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow diagram, all women accounted for |
| Selective reporting (reporting bias) | Unclear risk | This study was assessed from a published report without access to the protocol, so we do not know if all prespecified outcomes were reported |
| Other bias | Low risk | Groups appear to be comparable at baseline |