Ghanaie 2013.
Methods | A double‐blind, placebo‐controlled RCT. | |
Participants | Setting: Alzahra educational hospital in Rasht city, Iran. Inclusion criteria
Exclusion criteria
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Interventions | Intervention (N = 36): 20 mg isosorbide‐5‐mononitrate tablets vaginally twice each 12 h prior to admission for IOL. Women asked to come back urgently to the hospital in case they had leakage, contractions or bleeding. If they had no symptoms they should come back after 12 h. In the next visit, women were asked about the side effects of the tablets including headache and palpitations. If the contraction had not started, another 20 mg of IMN was administered and the patients were asked to come back after 12 h. Immediately after hospitalisation, the Bishop score was assessed and induction with oxytocin was commenced. Control (N = 36): 2 placebo tablets of similar design inserted vaginally twice each 12 h, prior to admission for IOL (according to regimen described above). |
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Outcomes | Change in Bishop score Mean time to active phase of labour Admission to birth interval Type of birth CS indications (meconium, failure to progress, fetal distress) Min Apgar Headache Palpitation Need for NICU Fetal complications Need for blood transfusion |
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Notes | Article abstract in English, full article in Iranian. An Iranian‐speaking colleague (E Shakibazadeh) kindly completed data extraction for risk of bias assessment and additional data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly allocated to 2 intervention and control groups using random blocks. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Women | Unclear risk | The authors have suggested that their study is a double blind study. However, there is no further information provided. |
Blinding (performance bias and detection bias) Clinical staff | Unclear risk | The authors have suggested that their study is a double blind study. However, there is no further information provided. |
Blinding (performance bias and detection bias) Outcome assessor | Unclear risk | The authors have suggested that their study is a double blind study. However, there is no further information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Full translation required. |
Selective reporting (reporting bias) | Unclear risk | all specified outcomes were reported. |
Other bias | Unclear risk | Full translation required. |