Yazdizadeh 2013.
| Methods | A randomised double‐blind, placebo‐controlled trial conducted in Sina Hospital (an education hospital in Ahvaz, Iran) between June to October 2010. Trial was conducted in an outpatient setting. | |
| Participants | 90 primiparous women presenting to the hospital with any sign of labour were recruited for the study. Inclusion criteria: primiparous women, between age 18‐35 years, Bishop score < 6, BMI between 19.8‐26, cephalic presentation, singleton fetus, normal stress test or biophysical profile in last 48 hours and gestation age of 40‐42 weeks. Exclusion criteria: women with headache, alcohol abuse, polyhydramnios, placenta praevia or abruption and with any contraindication to induction of labour were excluded from the study. |
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| Interventions | 90 women recruited in the study were randomised into 2 groups. ISMN group received 2 doses of 40 mg ISMN vaginally at 0 and 12 hours. The other group received placebo tablets vaginally at 0 and 12 hours. | |
| Outcomes |
Maternal: changes in Bishop score, duration between drug administration to active phase of labour, induction to delivery interval, amount of oxytocin used, length of second and third stages of labour and caesarean section rates. Fetal: Apgar scores at 1st and 5th minute after birth. |
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| Notes | This trial recruited women coming with signs of labour. | |
| 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 | Coded drug boxes. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10 dropouts from the study not explained. |
| Selective reporting (reporting bias) | Unclear risk | Unclear. |
| Other bias | Unclear risk | Unclear. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both patient and therapist blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No evidence to the contrary. |
AFI: amniotic fluid index BMI: body mass index CTG: cardiotocograph EFW: estimated fetal weight FHR: fetal heart rate GTN: glyceral trinitrate ISDN: isosorbide dinitrate ISMN: isosorbide mononitrate ITT: intention‐to‐treat IUGR: intrauterine growth restriction mcg: microgram mg: milligram NICU: neonatal intensive care unit PET: pre‐eclamptic toxaemia PGE2: prostaglandin E2