Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Drug: Placebos
- Registration Number
- NCT03544606
- Lead Sponsor
- ahmed nagy shaker ramadan
- Brief Summary
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?
- Detailed Description
* 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- Singleton pregnancy.
- Cephalic presentation.
- Bishop score < 6.
- Average size of the fetus.
- Adequate pelvic dimensions.
- Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
-
• Previous uterine scar.
- Patients with regular uterine contractions.
- Malpresentation.
- Multifetal gestation.
- Prelabour rupture of membranes.
- Established fetal distress.
- Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
- Antepartum hemorrhage.
- Active genital herpes infection.
- Severe maternal illness (e.g. severe preeclampsia).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebos group Placebos In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given isosorbide mononitrate group isosorbide mononitrate In vaginal IMN group (group 1) 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.
- Primary Outcome Measures
Name Time Method admission-delivery interval up to 24 hours The time from initiation labor induction and delivery of placenta
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
faculty of medicine - Kafr Elsheikh university
🇪🇬Kafr Ash Shaykh, Egypt