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

NCT03544606 | Completed Phase 4

• 1 other identifier: ISMN and labor induction
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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?

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• admission-delivery interval

  The time from initiation labor induction and delivery of placenta

  up to 24 hours

Study Arms (2)

isosorbide mononitrate group

EXPERIMENTAL

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

placebos group

PLACEBO COMPARATOR

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

Interventions

isosorbide mononitrate DRUG

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.

Also known as: Effox 40 mg

isosorbide mononitrate group

Placebos DRUG

In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given

Also known as: pyridoxine

placebos group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ahmed nagy shaker ramadan: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

faculty of medicine - Kafr Elsheikh university

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Interventions

isosorbide-5-mononitrate; Pyridoxine

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed N Shaker, MD

  faculty of medicine - Kafr elsheikh university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 4, 2018
• Study Start: December 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)