The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor. Research Hypothesis: In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery. Research Questions: Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?
* Type of Study : Prospective double blind randomized controlled clinical trial. * Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital. * Study Period : Expected 6 months from December 2023 to June 2024. * Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
160
40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
faculty of medicine - Kafr Elsheikh university
Kafr ash Shaykh, Egypt
admission-delivery interval
The time from initiation labor induction and delivery of placenta
Time frame: up to 24 hours
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