Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor

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?

Study Overview

• Status: Completed
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Drug: isosorbide mononitrate; Drug: Placebos

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).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt
    • faculty of medicine - Kafr Elsheikh university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Effox 40 mg
Placebo Comparator: 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	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; Other Names: pyridoxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
admission-delivery interval	The time from initiation labor induction and delivery of placenta	up to 24 hours

Collaborators and Investigators

• Sponsor: ahmed nagy shaker ramadan
• Collaborators: Kafrelsheikh University
• Investigators: Principal Investigator: Ahmed N Shaker, MD, faculty of medicine - Kafr Elsheikh university

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Natriuretic Agents; Micronutrients; Diuretics, Osmotic; Diuretics; Vitamins; Vitamin B Complex; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Pyridoxine
• Other Study ID Numbers: ISMN and labor induction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data supporting this research is available upon request. Please contact corresponding Author at ahmedafifi38527@postgrad.kasralainy.edu.eg for access to the relevant datasets. We are committed to transparency and facilitating the reproducibility of our findings, and we welcome inquiries regarding the data used in this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No