Trials / Completed
CompletedNCT03544606
Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- ahmed nagy shaker ramadan · Academic / Other
- Sex
- Female
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isosorbide mononitrate | 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. |
| DRUG | Placebos | In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-06-15
- Completion
- 2024-06-30
- First posted
- 2018-06-04
- Last updated
- 2024-08-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03544606. Inclusion in this directory is not an endorsement.