Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
NCT ID: NCT03544606
Last Updated: 2024-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2023-12-01
2024-06-30
Brief Summary
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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?
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
Group 1:
80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)
Group 2:
80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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isosorbide mononitrate group
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.
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.
placebos group
In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
Placebos
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
Interventions
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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.
Placebos
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
20 Years
35 Years
FEMALE
No
Sponsors
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Kafrelsheikh University
OTHER
ahmed nagy shaker ramadan
OTHER
Responsible Party
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ahmed nagy shaker ramadan
director
Principal Investigators
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Ahmed N Shaker, MD
Role: PRINCIPAL_INVESTIGATOR
faculty of medicine - Kafr elsheikh university
Locations
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faculty of medicine - Kafr Elsheikh university
Kafr ash Shaykh, , Egypt
Countries
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Other Identifiers
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ISMN and labor induction
Identifier Type: -
Identifier Source: org_study_id
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