Clinical trial NCT03544606: Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
Official title: Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Kafrelsheikh University
First posted: 2018-06-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided into 2 groups.

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.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* • 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).

Primary outcomes:
measure: admission-delivery interval
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of medicine - Kafr Elsheikh university
Study officials:
affiliation: faculty of medicine - Kafr elsheikh university
name: Ahmed N Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: