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. 2017 Sep 13;2017(9):CD007701. doi: 10.1002/14651858.CD007701.pub3

Ghanaie 2013.

Methods A double‐blind, placebo‐controlled RCT.
Participants Setting: Alzahra educational hospital in Rasht city, Iran.
Inclusion criteria
  • Nulliparous women

  • No complications in pregnancy

  • GA > 40 weeks (based on sonography < 20 weeks)

  • Singleton pregnancy

  • Cephalic presentation

  • Bishop score ≥ 4

  • AFI ≥ 5

  • Normal FHR

  • Intact membranes


Exclusion criteria
  • Having regular contractions (at least 3 x 45 minute contractions in 10 minutes)

  • History of headache

  • IMN intolerance

  • History of cardiopulmonary disease

  • Placenta previa or vaso previa

  • Cord prolapse

  • History of CS or myomectomy

  • Cephalo‐pelvic disproportion (CPD)

  • Cervical cancer

  • Abnormal FHR (tachycardia, bradycardia, deceleration)

  • Twin pregnancy

  • Non‐cephalic presentation

  • Polyhydramnios

  • High blood pressure (≥ 160/110 mg and proteinuria ≥+1)

  • Fetal weight ≥ 3500 g (based on estimated fetal weight (EFW) or sonography)

  • Small mother

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).
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
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.